Publications by authors named "Lee S Cohen"

114 Publications

Association of adverse prenatal exposure burden with child psychopathology in the Adolescent Brain Cognitive Development (ABCD) Study.

PLoS One 2021 28;16(4):e0250235. Epub 2021 Apr 28.

Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA, United States of America.

Objective: Numerous adverse prenatal exposures have been individually associated with risk for psychiatric illness in the offspring. However, such exposures frequently co-occur, raising questions about their cumulative impact. We evaluated effects of cumulative adverse prenatal exposure burden on psychopathology risk in school-aged children.

Methods: Using baseline surveys from the U.S.-based Adolescent Brain and Cognitive Development (ABCD) Study (7,898 non-adopted, unrelated children from 21 sites, age 9-10, and their primary caregivers), we examined 8 retrospectively-reported adverse prenatal exposures in relation to caregiver-reported total and subscale Child Behavior Checklist (CBCL) scores. We also assessed cumulative effects of these factors on CBCL total as a continuous measure, as well as on odds of clinically significant psychopathology (CBCL total ≥60), in both the initial set and a separate ABCD sample comprising an additional 696 sibling pairs. Analyses were conducted before and after adjustment for 14 demographic and environmental covariates.

Results: In minimally and fully adjusted models, 6 exposures (unplanned pregnancy; maternal alcohol, marijuana, and tobacco use early in pregnancy; pregnancy complications; and birth complications) independently associated with significant but small increases in CBCL total score. Among these 6, none increased the odds of crossing the threshold for clinically significant symptoms by itself. However, odds of exceeding this threshold became significant with 2 exposures (OR = 1.86, 95% CI 1.47-2.36), and increased linearly with each level of exposure (OR = 1.39, 95% CI 1.31-1.47), up to 3.53-fold for ≥4 exposures versus none. Similar effects were observed in confirmatory analysis among siblings. Within sibling pairs, greater discordance for exposure load associated with greater CBCL total differences, suggesting that results were not confounded by unmeasured family-level effects.

Conclusion: Children exposed to multiple common, adverse prenatal events showed dose-dependent increases in broad, clinically significant psychopathology at age 9-10. Fully prospective studies are needed to confirm and elaborate upon this pattern.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0250235PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8081164PMC
April 2021

The safety of asthma medications during pregnancy and lactation: Clinical management and research priorities.

J Allergy Clin Immunol 2021 Jun 10;147(6):2009-2020. Epub 2021 Mar 10.

Kaiser Permanente Medical Center, San Diego, Calif.

Asthma is one of the most common underlying diseases in women of reproductive age that can lead to potentially serious medical problems during pregnancy and lactation. A group of key stakeholders across multiple relevant disciplines was invited to take part in an effort to prioritize, strategize, and mobilize action steps to fill important gaps in knowledge regarding asthma medication safety in pregnancy and lactation. The stakeholders identified substantial gaps in the literature on the safety of asthma medications used during pregnancy and lactation and prioritized strategies to fill those gaps. Short-term action steps included linking data from existing complementary study designs (US and international claims data, single drug pregnancy registries, case-control studies, and coordinated systematic data systems). Long-term action steps included creating an asthma disease registry, incorporating the disease registry into electronic health record systems, and coordinating care across disciplines. The stakeholders also prioritized establishing new infrastructures/collaborations to perform research in pregnant and lactating women and to include patient perspectives throughout the process. To address the evidence gaps, and aid in populating product labels with data that inform clinical decision making, the consortium developed a plan to systematically obtain necessary data in the most efficient and timely manner.
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http://dx.doi.org/10.1016/j.jaci.2021.02.037DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8185876PMC
June 2021

Reproductive safety of aripiprazole: data from the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics.

Arch Womens Ment Health 2021 Mar 12. Epub 2021 Mar 12.

Ammon-Pinizzotto Center for Women's Mental Health, Massachusetts General Hospital, Boston, MA, USA.

Aripiprazole has become one of the most commonly prescribed psychotropics, making a more comprehensive understanding of its reproductive safety profile a priority. The goal of the current analysis was to determine the risk of major malformations in infants exposed during the first trimester of pregnancy to aripiprazole compared to infants whose mothers had psychiatric diagnoses but did not use an atypical antipsychotic during pregnancy. The National Pregnancy Registry for Atypical Antipsychotics is a prospective pharmacovigilance program in which pregnant women are enrolled and interviewed during pregnancy and the postpartum period. Medical records are assessed to confirm presence or absence of major malformations. Pregnant women ages 18-45 with psychiatric diagnoses are enrolled. As of April 2020, N = 848 women who had delivered infants were eligible for analyses. A total of 158 women with first trimester exposure to aripiprazole were compared to 690 controls. For 163 infants born to women in the exposed group, seven major malformations were confirmed (4.29%), compared to fourteen of the 690 unexposed infants (1.99%). The unadjusted odds ratio for major malformations between aripiprazole-exposed and unexposed infants was 2.21 (95% confidence interval [CI] = (0.88, 5.57) The adjusted odds ratio for major malformations was 1.35 (95% confidence interval [CI] = (0.43, 4.20). After adjustment for confounding variables, the risk of major malformations after first trimester exposure to aripiprazole was not significant compared to controls. While these results are reassuring, they are limited by relatively small numbers of participants. Future analyses with larger numbers are expected to provide more of a complete and precise reproductive safety profile regarding aripiprazole use during pregnancy. Trial registration: clinicaltrials.gov NCT01246765.
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http://dx.doi.org/10.1007/s00737-021-01115-6DOI Listing
March 2021

The Course of ADHD during Pregnancy.

J Atten Disord 2020 Dec 11:1087054720975864. Epub 2020 Dec 11.

Massachusetts General Hospital, Boston, USA.

Objective: The aim of this study was to characterize the course of ADHD during pregnancy.

Method: Women ages 18 to 45 were followed prospectively at <20 weeks, 24 weeks, and 36 weeks pregnant. Three groups emerged: women who discontinued, maintained, or adjusted their ADHD medications. ADHD symptoms were recorded using the AISRS. Anxiety, depression, stress, and functional impairment were monitored.

Results: A total of 25 women with ADHD were eligible for analysis. No significant difference observed between three groups in AISRS scores. Significant differences found between medication discontinuers vs adjusters for both mood and family functioning (EPDS, 5.3, < .0001; WFIRS, 3.3, = .0309). Significant differences also found between discontinuers vs maintainers for mood and family functioning (EPDS, 4.98, = .0009; WFIRS, 3.09, = .0197).

Conclusion: This preliminary study provides novel insight into the course of ADHD during pregnancy, underscoring mood and family functioning as critical domains that may contribute to growing use of psychostimulants during pregnancy.
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http://dx.doi.org/10.1177/1087054720975864DOI Listing
December 2020

Challenges in Determining Outcomes of Prenatal Exposure to Antidepressants.

J Clin Psychiatry 2020 05 12;81(3). Epub 2020 May 12.

Massachusetts General Hospital, Boston, Massachusetts

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http://dx.doi.org/10.4088/JCP.20com13269DOI Listing
May 2020

Impact of Estradiol Variability and Progesterone on Mood in Perimenopausal Women With Depressive Symptoms.

J Clin Endocrinol Metab 2020 03;105(3)

Division of Intramural Science, National Institute of Environmental Health Sciences, NIH.

Context: Women are at increased risk for depressive symptoms during the menopause transition. Changes in estradiol secretion and presence of vasomotor symptoms (VMS) contribute to perimenopausal depressive symptoms, but links with progesterone have not been investigated.

Objective: To determine whether estradiol variability, ovulatory levels of progesterone, and VMS burden are independently associated with perimenopausal depressive symptomatology.

Design And Intervention: Depressive symptoms, serum levels of estradiol and progesterone, and VMS frequency were assessed weekly in an 8-week observational study. Association of mood with estradiol variability, ovulatory levels of progesterone, and VMS frequency were estimated using generalized estimating equation models.

Setting: Academic medical center.

Patients: Fifty unmedicated perimenopausal women with mild-to-moderate depressive symptoms (mean Montgomery-Åsberg Depression Rating Scale [MADRS] score 15.5 ± 5.3).

Main Outcome Measure: Depressive symptoms (MADRS score).

Results: During the study, 90.0% of participants had varying estradiol levels, 51.1% had ovulatory progesterone levels, and 90% had VMS. Greater estradiol variability and absence of progesterone levels consistent with ovulation, but not VMS frequency, are associated with higher levels of depressive symptoms (β = 0.11 [95% confidence interval (95% CI), 0.04 to 0.18; P = 0.001]; β = -2.62 [95% CI, -4.52 to -0.71; P = 0.007], respectively), after accounting for higher body mass index, lifetime history of depression, and stressful life events.

Conclusions: Increasing dysregulation of ovarian hormones, but not VMS, associates with more depressive symptom burden during perimenopause. These results suggest that perimenopausal mood instability is driven by the underlying hormonal dysregulation of the menopause transition involving changes in both estradiol and progesterone.
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http://dx.doi.org/10.1210/clinem/dgz181DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7075107PMC
March 2020

The impact of obesity on pregnancy outcomes among women with psychiatric disorders: Results from a prospective pregnancy registry.

J Psychosom Res 2019 08 4;123:109735. Epub 2019 Jun 4.

Massachusetts General Hospital, Ammon-Pinizzotto Center for Women's Mental Health, 185 Cambridge Street, Suite 2200, Boston, MA 02114, USA.

Objective: Obesity is associated with an increased risk of adverse pregnancy outcomes. As individuals with psychiatric disorders are at a higher risk of obesity than the general population, we aimed to examine the effect of obesity on neonatal and maternal outcomes in this population.

Methods: Pregnant women with psychiatric disorders were enrolled in the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications (NCT01246765) and followed prospectively until 6 months postpartum. Pre-pregnancy body mass index was used to categorize participants as normal-weight, overweight, and obese to assess comparative risk of adverse outcomes.

Results: Within our sample of 584 participants (N = 252 normal-weight; N = 170 overweight; N = 162 obese), obesity was not significantly associated with higher risk for birth defects (OR: 3.19; 95% CI:0.79,12.95; p = 0.10; unadjusted due to the rarity of this outcome in the sample). After adjustment, women with obesity were at higher risk for gestational diabetes (p = 0.011; OR:3.23; 95% CI:1.30,7.98), as were women in the overweight BMI category (p = 0.003; OR:3.77; 95% CI:1.58,9.00). Among women with obesity, there was a tendency for a higher C-section rate (p = 0.07) compared to women in the normal-weight BMI category. Other outcomes were not significantly different among groups.

Conclusions: Peripartum complications associated with obesity are common among women with psychiatric illness; thus, it is important to develop antenatal weight management interventions for this population.
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http://dx.doi.org/10.1016/j.jpsychores.2019.109735DOI Listing
August 2019

Safety of Psychotropic Medications During Pregnancy.

Clin Perinatol 2019 06 28;46(2):215-234. Epub 2019 Mar 28.

Perinatal and Reproductive Psychiatry Program, Massachusetts General Hospital Center for Women's Mental Health, Harvard Medical School, Simches Research Building, 185 Cambridge Street, Suite 2200, Boston, MA 02114, USA.

Risks, benefits, alternatives, and appropriateness of psychotropic medications, including risks of no treatment, are discussed for antidepressants, mood-stabilizing medications, anxiolytic/sedative hypnotic medications, stimulants, and medication-assisted treatment of substance use disorders. Early screening, diagnosis, and intervention prior to and/or during pregnancy often reduce morbidity and mortality of mental health disorders for mothers and infants.
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http://dx.doi.org/10.1016/j.clp.2019.02.004DOI Listing
June 2019

A prenatal supplement with methylfolate for the treatment and prevention of depression in women trying to conceive and during pregnancy.

Ann Clin Psychiatry 2019 02;31(1):4-16

Psychiatry Department, Ammon-Pinizzotto Center for Women's Mental Health, Massachusetts General Hospital, Boston, MA 02114 USA. E-MAIL:

Background: Women often seek antidepressant alternatives for major depressive disorder (MDD) in anticipation of or during pregnancy. In this preliminary study, EnBrace HR, a prenatal supplement containing methylfolate, was investigated for depressive relapse prevention and for acute treatment of MDD in women planning pregnancy or during pregnancy.

Methods: This 12-week open-label study included women with histories of MDD who were planning pregnancy or pregnant < 28 weeks. At enrollment, Group 1 participants were well (not depressed) and planned to discontinue antidepressants for pregnancy. Group 2 participants were depressed. Primary outcome variables by group included MDD relapse and depressive symptoms, verified with the Mini-International Neuropsychiatric Interview and the Montgomery-Åsberg Depression Rating Scale (MADRS), respectively. Biomarkers of inflammation and the folate cycle were collected.

Results: Group 1 participants (N = 11) experienced lower rates of depressive relapse (27.3% = .005) than expected from a historical comparison group and no significant changes in MADRS scores. Group 2 participants (N = 6) experienced significant improvements in MADRS scores ( = .001), with 5 (83.3%) improving >50% and 1 improving 33.3%. One adverse event occurred, a hospitalization for depression.

Conclusions: Results suggest EnBrace HR is a well-tolerated intervention with potential efficacy for prevention and treatment of perinatal depression. Larger controlled trials are necessary.
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February 2019

Course of major depressive disorder after pregnancy and the postpartum period.

Depress Anxiety 2018 12 7;35(12):1130-1136. Epub 2018 Sep 7.

Center for Women's Mental Health, Massachusetts General Hospital, Boston, Massachusetts.

Background: Maternal major depressive disorder (MDD) has an adverse effect on child development and increases risk for child psychopathology. It is paramount to understand the course of maternal depression during the childhood years particularly before, during, and after pregnancy.

Objective: To follow the course of MDD in women with prior histories of depression followed during an index pregnancy.

Methods: Subjects were women with histories of MDD who had participated in prior prospective, observational studies during pregnancy. In the follow-up, participants completed a structured interview that addressed (1) the course of MDD since their index pregnancy, (2) new psychiatric diagnoses, and (3) the course of MDD and treatment across subsequent pregnancies.

Results: Out of 129 eligible women, 48.8% participated (N = 63) with an average/mean time of 12.9 years (SD = 1.9, 8.8-16.7) elapsed since participation in the prior pregnancy studies. Although approximately one third reported sustained remission from MDD since the pregnancy during which they had been originally followed, of the remaining two thirds of women who reported subsequent depressive episodes, almost one fifth (∼12% of the total sample) endorsed depression more than 50% of the time following their index pregnancy. A total of 6.3% of the women with previous validated diagnoses of MDD reported new diagnoses of bipolar disorder. Women reported similar treatment choices regarding the use of antidepressants during pregnancies subsequent to the one followed in the previous study.

Conclusion: Women with MDD experienced high rates of recurrent depression across the childbearing years. This represents a critical variable for clinical care and research.
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http://dx.doi.org/10.1002/da.22836DOI Listing
December 2018

Guidelines for the Evaluation and Treatment of Perimenopausal Depression: Summary and Recommendations.

J Womens Health (Larchmt) 2019 02 5;28(2):117-134. Epub 2018 Sep 5.

11 Department of Psychiatry, Queen's University School of Medicine, Ontario Canada.

There is a new appreciation of the perimenopause-defined as the early and late menopause transition stages as well as the early postmenopause-as a window of vulnerability for the development of both depressive symptoms and major depressive episodes. However, clinical recommendations on how to identify, characterize and treat clinical depression are lacking. To address this gap, an expert panel was convened to systematically review the published literature and develop guidelines on the evaluation and management of perimenopausal depression. The areas addressed included: (1) epidemiology; (2) clinical presentation; (3) therapeutic effects of antidepressants; (4) effects of hormone therapy; and (5) efficacy of other therapies (e.g., psychotherapy, exercise, and natural health products). Overall, evidence generally suggests that most midlife women who experience a major depressive episode during the perimenopause have experienced a prior episode of depression. Midlife depression presents with classic depressive symptoms commonly in combination with menopause symptoms (i.e., vasomotor symptoms, sleep disturbance), and psychosocial challenges. Menopause symptoms complicate, co-occur, and overlap with the presentation of depression. Diagnosis involves identification of menopausal stage, assessment of co-occurring psychiatric and menopause symptoms, appreciation of the psychosocial factors common in midlife, differential diagnoses, and the use of validated screening instruments. Proven therapeutic options for depression (i.e., antidepressants, psychotherapy) are the front-line treatments for perimenopausal depression. Although estrogen therapy is not approved to treat perimenopausal depression, there is evidence that it has antidepressant effects in perimenopausal women, particularly those with concomitant vasomotor symptoms. Data on estrogen plus progestin are sparse and inconclusive.
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http://dx.doi.org/10.1089/jwh.2018.27099.mensocrecDOI Listing
February 2019

Guidelines for the evaluation and treatment of perimenopausal depression: summary and recommendations.

Menopause 2018 10;25(10):1069-1085

Department of Psychiatry, Queen's University School of Medicine, Ontario CA.

There is a new appreciation of the perimenopause - defined as the early and late menopause transition stages as well as the early postmenopause - as a window of vulnerability for the development of both depressive symptoms and major depressive episodes. However, clinical recommendations on how to identify, characterize and treat clinical depression are lacking. To address this gap, an expert panel was convened to systematically review the published literature and develop guidelines on the evaluation and management of perimenopausal depression. The areas addressed included: 1) epidemiology; 2) clinical presentation; 3) therapeutic effects of antidepressants; 4) effects of hormone therapy; and 5) efficacy of other therapies (eg, psychotherapy, exercise, and natural health products). Overall, evidence generally suggests that most midlife women who experience a major depressive episode during the perimenopause have experienced a prior episode of depression. Midlife depression presents with classic depressive symptoms commonly in combination with menopause symptoms (ie, vasomotor symptoms, sleep disturbance), and psychosocial challenges. Menopause symptoms complicate, co-occur, and overlap with the presentation of depression. Diagnosis involves identification of menopausal stage, assessment of co-occurring psychiatric and menopause symptoms, appreciation of the psychosocial factors common in midlife, differential diagnoses, and the use of validated screening instruments. Proven therapeutic options for depression (ie, antidepressants, psychotherapy) are the front-line treatments for perimenopausal depression. Although estrogen therapy is not approved to treat perimenopausal depression, there is evidence that it has antidepressant effects in perimenopausal women, particularly those with concomitant vasomotor symptoms. Data on estrogen plus progestin are sparse and inconclusive.
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http://dx.doi.org/10.1097/GME.0000000000001174DOI Listing
October 2018

Psychiatric Medications and Reproductive Safety: Scientific and Clinical Perspectives Pertaining to the US FDA Pregnancy and Lactation Labeling Rule.

J Clin Psychiatry 2018 07 17;79(4). Epub 2018 Jul 17.

Pregnancy labeling of prescription medications in the US is in the midst of a major transformation. The FDA's previous system, which used letter ratings to convey drug safety, was simple but led to misunderstandings-both faulty assurances and undue concerns. The new system, established under the Pregnancy and Lactation Labeling Rule, aims for more descriptive and up-to-date explanations of risk as well as context needed for informed decision-making based on available data. In April 2017, a conference titled "Pharmacovigilance, Reproductive Safety, and the Pregnancy and Lactation Labeling Rule" brought together clinicians and researchers, FDA officials, and representatives of the public and industry to discuss a host of questions relating to the new system. This Academic Highlights article summarizes their discussions, which included topics such as how the new system came about and how the new labeling can be used effectively to inform physician-patient conversations about use of medications during pregnancy and ultimately the clinical decisions that follow.​​.
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http://dx.doi.org/10.4088/JCP.18ah38120DOI Listing
July 2018

Risk of Major Malformations in Infants Following First-Trimester Exposure to Quetiapine.

Am J Psychiatry 2018 12 16;175(12):1225-1231. Epub 2018 Aug 16.

From the Department of Psychiatry and the Ammon-Pinizzotto Center for Women's Mental Health, Massachusetts General Hospital, Boston; Harvard Medical School, Boston; the Neurological Institute, Cleveland Clinic, Cleveland; the Prenatal Diagnosis and Medical Genetics Program, Mount Sinai Hospital, Toronto; and the Harvard T.H. Chan School of Public Health, Harvard University, Boston.

Objective: Second-generation antipsychotics are commonly prescribed to reproductive-age women for the treatment of a spectrum of psychiatric disorders. Quetiapine is the most commonly prescribed medication in this class, and therefore a better understanding of its reproductive safety profile is critical. The goal of this study was to determine the risk of major malformations among infants exposed to quetiapine during pregnancy compared with a group of infants whose mothers had a history of psychiatric morbidity but who did not use a second-generation antipsychotic during pregnancy.

Method: The National Pregnancy Registry for Atypical Antipsychotics interviews pregnant women ages 18-45 during pregnancy and the postpartum period. Obstetric, labor, and delivery medical records and pediatric medical records from the first 6 months of life were screened for evidence of major malformations, followed by adjudication by a blinded dysmorphologist. Women with first-trimester exposure to quetiapine were compared with control subjects without exposure to second-generation antipsychotics.

Results: As of March 2017, 888 women had enrolled prospectively and 357 were eligible for analysis. Of these, 152 women with first-trimester exposure to quetiapine were compared with 205 control subjects without any second-generation antipsychotic exposure. For the 155 infants born to women in the exposed group (including three sets of twins), two major malformations were confirmed (1.3%), compared with three major malformations among the 210 infants born in the unexposed group (including five sets of twins) (1.4%). The unadjusted odds ratio for major malformations between infants with and without quetiapine exposure was 0.90 (95% CI=0.15, 5.46), which is consistent with the pooled estimate of the available controlled data on fetal exposure to quetiapine.

Conclusions: These data regarding the safety of fetal exposure to quetiapine in a small sample of well-characterized participants are reassuring given that the confidence interval does not exceed a fivefold increased risk of major malformations relative to psychiatric control subjects. Future analyses based on ongoing data collection will produce more precise estimates.
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http://dx.doi.org/10.1176/appi.ajp.2018.18010098DOI Listing
December 2018

Predictors of Depressive Relapse in Women Undergoing Infertility Treatment.

J Womens Health (Larchmt) 2018 11 1;27(11):1408-1414. Epub 2018 Aug 1.

1 Ammon-Pinizzotto Center for Women's Mental Health, Massachusetts General Hospital , Boston, Massachusetts.

Background: Despite high prevalence rates among women of mood disorders and of infertility, there is a paucity of systematic data to inform the treatment of women at risk for psychiatric morbidity in the context of assisted reproductive technologies (ART). The objective was to delineate predictors of depressive relapse in women with histories of mood disorders during ART, including the role of psychotropic medication continuation.

Methods: This was a prospective observational study of women undergoing ART with past diagnoses of major depressive disorder (MDD) or bipolar depression. For 6-months, follow-up included assessments of mood, perceived stress, and partner support. A subsample participated in biomarker collection. Depressive relapse was confirmed using Mini-International Neuropsychiatric Interview.

Results: N = 38 were evaluable. Participants with MDD (N = 25) experienced a depressive relapse rate of 44.0%. Relapse rates among antidepressant maintainers (N = 15; relapse rate = 40.0%) and antidepressant discontinuers (N = 10; relapse rate = 50.0%) were not significantly different. Among participants with bipolar disorder (N = 13), the overall relapse rate was 30.8%. Among psychotropic medication maintainers (N = 10), 40.0% relapsed, and among discontinuers (N = 3), none relapsed. Scores on the Perceived Stress Scale correlated with relapse risk (odds ratio [OR] = 1.17, 95% confidence interval [CI]: 1.08-1.26, p = 0.0065). C-reactive protein was associated with relapse (OR = 1.92, 95% CI: 1.43-2.55, p < 0.0001); blood cortisol and interleukin-6 were not.

Conclusions: Risk of depressive relapse among women undergoing ART is considerable. Medication continuation does not adequately confer relapse prevention. Stress and inflammation appear to contribute to risk of relapse. Additional strategies to mitigate depressive relapse in at-risk women undergoing ART are needed.
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http://dx.doi.org/10.1089/jwh.2017.6878DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6247370PMC
November 2018

Obstetrical and neonatal outcomes after benzodiazepine exposure during pregnancy: Results from a prospective registry of women with psychiatric disorders.

Gen Hosp Psychiatry 2018 Jul - Aug;53:73-79. Epub 2018 May 29.

Massachusetts General Hospital, Center for Women's Mental Health, 185 Cambridge St, Boston, MA 02114, United States.

Objective: The goal of this analysis was to examine the effect of benzodiazepine use during pregnancy on maternal and neonatal outcomes in a cohort of women with psychiatric disorders.

Methods: 794 evaluable women from the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications were followed across pregnancy (N = 144 exposed to benzodiazepines and N = 650 unexposed). Data obtained through maternal report and medical records included maternal outcomes (cesarean section, preeclampsia) and neonatal outcomes (birth weight, breathing difficulty, feeding difficulty, head circumference, 5-minute Apgar score, muscular and/or extrapyramidal symptoms, NICU admission, prematurity).

Results: In adjusted analyses, infants exposed to benzodiazepines in utero were more likely to be admitted to the NICU (OR: 2.02, 95% CI: 1.11, 3.66) and to have small head circumferences (OR: 3.89, 95% CI: 1.25, 12.03) compared to unexposed infants. Other neonatal adverse effects such as respiratory distress or muscular symptoms including hypotonia were not observed. There were no significant differences in adverse obstetrical outcomes.

Conclusions: Infants exposed to benzodiazepines during pregnancy had an increased risk of NICU admissions and small head circumferences. Confounding from psychiatric symptoms and other variables cannot be ruled out as contributors to these findings.
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http://dx.doi.org/10.1016/j.genhosppsych.2018.05.010DOI Listing
November 2018

Continuation of Atypical Antipsychotic Medication During Early Pregnancy and the Risk of Gestational Diabetes.

Am J Psychiatry 2018 06 7;175(6):564-574. Epub 2018 May 7.

From the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston; the Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston; the Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston; and the Perinatal and Reproductive Psychiatry Program, Center for Women's Mental Health, Massachusetts General Hospital, Boston.

Objective: Some atypical antipsychotics are associated with metabolic side effects, which are risk factors for gestational diabetes. The authors examined the risk of developing gestational diabetes associated with the continuation of treatment with aripiprazole, ziprasidone, quetiapine, risperidone, and olanzapine during pregnancy compared with discontinuation of these antipsychotic drugs.

Method: Nondiabetic pregnant women who were linked to a live-born infant and enrolled in Medicaid (2000-2010) and who received one or more prescriptions dispensed for an antipsychotic drug during the 3 months before pregnancy were included in the analyses. Among 1,543,334 pregnancies, some expectant mothers at baseline were receiving treatment with aripiprazole (N=1,924), ziprasidone (N=673), quetiapine (N=4,533), risperidone (N=1,824), or olanzapine (N=1,425). For each antipsychotic drug, women with two or more dispensings ("continuers") were compared with women with no dispensings ("discontinuers") during the first half of pregnancy. A generalized linear model and propensity-score stratification were used to obtain absolute and relative risks of developing gestational diabetes, with adjustment for confounders.

Results: Women who continued antipsychotic treatment during pregnancy generally had higher comorbidity and longer baseline antipsychotic use. The crude risk of developing gestational diabetes among continuers compared with discontinuers, respectively, was 4.8% and 4.5% for aripiprazole, 4.2% and 3.8% for ziprasidone, 7.1% and 4.1% for quetiapine, 6.4% and 4.1% for risperidone, and 12.0% and 4.7% for olanzapine. The adjusted relative risks were 0.82 (95% CI=0.50-1.33) for aripiprazole, 0.76 (95% CI=0.29-2.00) for ziprasidone, 1.28 (95% CI=1.01-1.62) for quetiapine, 1.09 (95% CI=0.70-1.70) for risperidone, and 1.61 (95% CI=1.13-2.29) for olanzapine.

Conclusions: Compared with women who discontinued use of an atypical antipsychotic medication before the start of pregnancy, women who continued treatment with olanzapine or quetiapine had an increased risk of gestational diabetes that may be explained by the metabolic effects associated with these two drugs.
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http://dx.doi.org/10.1176/appi.ajp.2018.17040393DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5988929PMC
June 2018

Gestational Weight Gain and Pre-pregnancy Body Mass Index Associated With Second-Generation Antipsychotic Drug Use During Pregnancy.

Psychosomatics 2018 Mar - Apr;59(2):125-134. Epub 2017 Sep 21.

Massachusetts General Hospital, Department of Psychiatry, Ammon-Pinizzotto, Center for Women's Mental Health, Boston, MA.

Background: Obesity during pregnancy is the most common high-risk obstetric condition, resulting in increased rates of adverse maternal and neonatal outcomes. Individuals with psychiatric disorders have a higher risk of obesity than the general population, but data regarding implications of obesity in women with psychiatric disorders are sparse.

Objective: The objective of this study was to assess pre-pregnancy weights and gestational weight gain in women who were exposed to second-generation antipsychotics (SGAs) during pregnancy compared to controls.

Methods: We assessed pre-pregnancy weights and gestational weight gain from the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics for patients exposed to SGAs and controls unexposed to these medicines during pregnancy. Both groups experienced similar psychiatric morbidity.

Results: A total of 403 participants had evaluable data for these analyses (N = 279 exposed to SGAs; N = 124 controls). The mean pre-pregnancy weight, body mass index (BMI), and likelihood to begin pregnancy with an obese BMI were significantly higher in the exposed group compared to controls (p = 0.0003, p < 0.0001, and p < 0.0001 respectively), as were the mean weight and BMI at delivery (p < 0.0001). The mean weight gain did not differ significantly between groups. Across pre-pregnancy BMI categories, both groups gained more than the recommended amount of weight during pregnancy.

Conclusion: We found that women exposed to SGAs began pregnancy with higher BMIs than controls. Both exposed and unexposed groups experienced similar weight gain during pregnancy. Strategies are needed to prevent excessive gestational weight gain and to reduce pre-pregnancy obesity in women with psychiatric disorders, especially those treated with SGAs.
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http://dx.doi.org/10.1016/j.psym.2017.09.002DOI Listing
March 2019

Vortioxetine for major depressive disorder, vasomotor, and cognitive symptoms associated with the menopausal transition.

Ann Clin Psychiatry 2017 Nov;29(4):249-257

Ammon-Pinizzotto Center for Women's, Mental Health, Massachusetts General Hospital, Boston, MA, USA. E-mail:

Background: In a preliminary trial, we assessed the efficacy of vortioxetine for major depressive disorder (MDD) during the menopausal transition. Secondary outcomes included hot flashes (HFs), anxiety, and cognitive complaints.

Methods: Perimenopausal and early postmenopausal women with MDD (N = 27) received 8 weeks of open-label, flexible-dose treatment with vortioxetine. The Montgomery-Åsberg Depression Rating Scale (MADRS) was the primary outcome measure. Secondary measures included: HF frequency, the Greene Climacteric Scale (GCS), Menopause-Specific Quality of Life Questionnaire (MEN-QOL), Beck Anxiety Inventory (BAI), Cognitive and Physical Functioning Questionnaire (CPFQ), Digit Symbol Substitution Test (DSST), and Cogstate testing.

Results: Of the 27 women, 24 (88.8%) were evaluated (≥1 follow-up), and 21 (77.8%) completed the study; 1 discontinued because of adverse effects. The mean MADRS score decreased significantly (P = .0001) from 31.3 (standard deviation [SD] = 5.5) at pretreatment to 8.1 (SD = 7.8) at posttreatment. The depression response rate (≥50% reduction in MADRS) and remission rate (final MADRS ≤10) were 75% and 70.8%, respectively. GCS, MEN-QOL, BAI, CPFQ, and DSST scores improved significantly (P = .0030, P = .0001, P = .0001, P = .0001, and P = .0133, respectively); Cogstate test scores did not. Frequency and severity of HFs improved significantly (P = .0291 and P = .0299, respectively).

Conclusions: These data support further study of vortioxetine for treating menopausal depression and associated symptoms.
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November 2017

Treatment of Premenstrual Breakthrough of Depression With Adjunctive Oral Contraceptive Pills Compared With Placebo.

J Clin Psychopharmacol 2017 Oct;37(5):609-614

From the *Women's Hormones and Aging Research Program, Department of Psychiatry, Brigham and Women's Hospital and Dana Farber Cancer Institute/Harvard Medical School; and †Center for Women's Mental Health, Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, MA.

Purpose/background: Two-thirds of women with depressive disorders report reemergence of depression premenstrually, or premenstrual exacerbation (PME), despite effective treatment of the underlying mood disorder during the remainder of the cycle. There is a paucity of studies that rigorously assess treatments targeting PME. Open-label data suggest that augmentation of antidepressants with the oral contraceptive pill (OCP) drospirenone and ethinyl estradiol (DRSP/EE) improves depressive symptoms that break through treatment premenstrually. We now report results of a randomized placebo-controlled OCP augmentation trial.

Methods: Women with unipolar depressive disorders in remission on stable antidepressant doses with a 30% increase in Montgomery-Åsberg Depression Rating Scale (MADRS) scores from the follicular to luteal phase were randomized to double-blind augmentation of antidepressant with either DRSP/EE or placebo for 2 months. The MADRS and Daily Record of Severity of Problems (DRSP) measures were anchored to the menstrual cycle phase.

Findings/results: Of 32 women randomized, 25 (n = 12 DRSP/EE, n = 13 placebo) completed the trial. Premenstrual MADRS scores declined by a median of 43.6% and 38.9% (P = 0.59), and premenstrual DRSP scores declined by a median of 23.5% and 20.9% (P = 0.62) in the DRSP/EE and placebo groups, respectively. There was a trend toward greater improvement in premenstrual DRSP scores for women with fewer lifetime depressive episodes (r = -0.40, P = 0.06).

Implications/conclusions: Findings from this small randomized trial suggest that OCP augmentation of antidepressants may not be effective for treating premenstrual breakthrough of depression. Future studies should target women established to have hormonal sensitivity prior to antidepressant therapy and those with fewer lifetime depressive episodes.
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http://dx.doi.org/10.1097/JCP.0000000000000761DOI Listing
October 2017

Use of atypical antipsychotics in pregnancy and maternal gestational diabetes.

J Psychiatr Res 2017 12 29;95:84-90. Epub 2017 Jul 29.

Ammon-Pinizzotto Center for Women's Mental Health, Department of Psychiatry Massachusetts General Hospital, Harvard Medical School, Boston, USA.

Background: Second generation antipsychotic medications (SGAs) are widely used by reproductive-age women to treat a number of psychiatric illnesses. Some SGAs have been associated with an increased risk of developing diabetes, although information regarding their diabetogenic effect in pregnant women is scarce.

Objective: To evaluate the risk of gestational diabetes (GDM) among women treated with SGA.

Method: The Massachusetts General Hospital (MGH) National Pregnancy Registry for Atypical Antipsychotics (NPRAA) collects data on drug use, pregnancy outcomes, and other characteristics from pregnant women, ages 18-45 years, using 3 phone interviews conducted at (1) enrollment during pregnancy, (2) 7 months' gestation, and (3) 2-3 months postpartum. Information on GDM was abstracted from obstetric and delivery medical records. The study population was restricted to women without pre-gestational diabetes. Pregnancies exposed to SGAs during the first trimester were compared with a reference group of women with psychiatric conditions but not treated with SGAs during pregnancy. Generalized linear models were used to estimate adjusted odds ratios (OR) and 95% confidence intervals (CI) for GDM.

Results: Of 303 women exposed to SGAs, 33 (10.9%) had GDM compared to 16 (10.7%) in the 149 non-exposed women. The crude OR of GDM for SGA was 1.02 (95% CI, 0.54-1.91). After adjustment for maternal age, race, marital status, employment status, level of education, smoking, and primary psychiatric diagnosis, the OR moved to 0.79 (0.40-1.56).

Conclusions: Findings did not suggest an increased risk of GDM associated with exposure to SGAs during pregnancy in women who had used SGA before pregnancy without developing diabetes, compared to psychiatrically ill women who were not exposed to SGA.

Trial Registration: ClinicalTrials.gov identifier: NCT01246765.
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http://dx.doi.org/10.1016/j.jpsychires.2017.07.025DOI Listing
December 2017

The global prevalence of postpartum psychosis: a systematic review.

BMC Psychiatry 2017 07 28;17(1):272. Epub 2017 Jul 28.

Center for Women's Mental Health, Perinatal and Reproductive Psychiatry Clinical Research Program, Massachusetts General Hospital, Simches Research Building, 185 Cambridge St Suite 2200, Boston, MA, 02114, USA.

Background: Mental health is a significant contributor to global burden of disease and the consequences of perinatal psychiatric morbidity can be substantial. We aimed to obtain global estimates of puerperal psychosis prevalence based on population-based samples and to understand how postpartum psychosis is assessed and captured among included studies.

Methods: In June 2014, we searched PubMed, CiNAHL, EMBASE, PsycINFO, Sociological Collections, and Global Index Medicus for publications since the year 1990. Criteria for inclusion in the systematic review were: use of primary data relevant to pre-defined mental health conditions, specified dates of data collection, limited to data from 1990 onwards, sample size >200 and a clear description of methodology. Data were extracted from published peer reviewed articles.

Results: The search yielded 24,273 publications, of which six studies met the criteria. Five studies reported incidence of puerperal psychosis (ranging from 0.89 to 2.6 in 1000 women) and one reported prevalence of psychosis (5 in 1000). Due to the heterogeneity of methodologies used across studies in definitions and assessments used to identify cases, data was not pooled to calculate a global estimate of risk.

Conclusions: This review confirms the relatively low rate of puerperal psychosis; yet given the potential for serious consequences, this morbidity is significant from a global public health perspective. Further attention to consistent detection of puerperal psychosis can help provide appropriate treatment to prevent harmful consequences for both mother and baby.
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http://dx.doi.org/10.1186/s12888-017-1427-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5534064PMC
July 2017

Antipsychotic Medication Use Among Publicly Insured Pregnant Women in the United States.

Psychiatr Serv 2017 Nov 15;68(11):1112-1119. Epub 2017 Jun 15.

Dr. Park, Dr. Huybrechts, Dr. Bateman, Dr. Desai, Dr. Patorno, and Ms. Mogun are with the Department of Medicine, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston. Dr. Park is also with the Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, where Dr. Jacqueline Cohen and Dr. Hernandez-Diaz are affiliated. Dr. Bateman is also with the Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston. Dr. Lee Cohen is with the Center for Women's Mental Health, Department of Psychiatry, Massachusetts General Hospital, Boston.

Objective: Given the increasing use and broadening of indications for use of antipsychotic medications in the general population, as well as the paucity of information on the safety of this drug class during pregnancy, the study documented patterns of antipsychotic medication use among pregnant women.

Methods: Medicaid Analytic eXtract data (2001-2010) from pregnant women who delivered live-born infants were used. Antipsychotic use at both the class and the individual drug level was defined based on dispensed outpatient prescriptions. Users' characteristics, including mental disorder diagnoses, were described. Temporal trends in use, as well as discontinuation patterns and psychotropic polytherapy, during pregnancy were evaluated.

Results: Among 1,522,247 pregnancies, the prevalence of use of second-generation antipsychotics at any time during pregnancy increased threefold, from .4% to 1.3%, over the ten-year period, while the use of first-generation antipsychotics remained stable at around .1%. The increased use of second-generation antipsychotics was largely driven by more frequent use among patients with bipolar disorder. Quetiapine and aripiprazole were the most frequently dispensed drugs, and polytherapy with antipsychotics and antidepressants (65.2%), benzodiazepines (24.9%), and other mood stabilizers (22.0%) was common. More than 50% of women receiving an antipsychotic in the three months prior to pregnancy discontinued the drug during pregnancy.

Conclusions: A growing number of pregnant women in Medicaid are exposed to second-generation antipsychotics, frequently in combination with other psychotropic medications. This study highlights the importance of documenting the use and safety of these drugs during pregnancy to inform therapeutic decision making for pregnant women with psychiatric disorders.
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http://dx.doi.org/10.1176/appi.ps.201600408DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5665733PMC
November 2017

Delusional Pregnancy Presenting to the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics.

J Clin Psychopharmacol 2017 08;37(4):472-474

Massachusetts General Hospital, Center for Women's Mental Health, Boston, MA. Massachusetts General Hospital, Center for Women's Mental Health, Boston, MA; Massachusetts General Hospital, Center for Women's Mental Health, Boston, MA and Cleveland Clinic, Cleveland Clinic Neurological Institute, Cleveland, OH Massachusetts General Hospital, Center for Women's Mental Health, Boston, MA.

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http://dx.doi.org/10.1097/JCP.0000000000000732DOI Listing
August 2017

Lithium Use in Pregnancy and the Risk of Cardiac Malformations.

N Engl J Med 2017 06;376(23):2245-2254

From the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine (E.P., K.F.H., B.T.B., R.J.D., H.M.), and the Department of Anesthesiology, Perioperative and Pain Medicine (B.T.B.), Brigham and Women's Hospital and Harvard Medical School, the Department of Epidemiology, Harvard T.H. Chan School of Public Health (J.M.C., S.H.-D.), and the Center for Women's Mental Health, Department of Psychiatry, Massachusetts General Hospital (L.S.C.) - all in Boston.

Background: There has been concern that exposure to lithium early in pregnancy may be associated with a marked increase in the risk of Ebstein's anomaly (a right ventricular outflow tract obstruction defect) in infants and overall congenital cardiac defects, but data are conflicting and limited.

Methods: We conducted a cohort study involving 1,325,563 pregnancies in women who were enrolled in Medicaid and who delivered a live-born infant between 2000 and 2010. We examined the risk of cardiac malformations among infants exposed to lithium during the first trimester as compared with unexposed infants and, in secondary analyses, with infants exposed to another commonly used mood stabilizer, lamotrigine. Risk ratios and 95% confidence intervals were estimated with control for psychiatric and medical conditions, medications, and other potential confounders.

Results: Cardiac malformations were present in 16 of the 663 infants exposed to lithium (2.41%), 15,251 of the 1,322,955 nonexposed infants (1.15%), and 27 of the 1945 infants exposed to lamotrigine (1.39%). The adjusted risk ratio for cardiac malformations among infants exposed to lithium as compared with unexposed infants was 1.65 (95% confidence interval [CI], 1.02 to 2.68). The risk ratio was 1.11 (95% CI, 0.46 to 2.64) for a daily dose of 600 mg or less, 1.60 (95% CI, 0.67 to 3.80) for 601 to 900 mg, and 3.22 (95% CI, 1.47 to 7.02) for more than 900 mg. The prevalence of right ventricular outflow tract obstruction defects was 0.60% among lithium-exposed infants versus 0.18% among unexposed infants (adjusted risk ratio, 2.66; 95% CI, 1.00 to 7.06). Results were similar when lamotrigine-exposed infants were used as the reference group.

Conclusions: Maternal use of lithium during the first trimester was associated with an increased risk of cardiac malformations, including Ebstein's anomaly; the magnitude of this effect was smaller than had been previously postulated. (Funded by the National Institute of Mental Health.).
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http://dx.doi.org/10.1056/NEJMoa1612222DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5667676PMC
June 2017

A longitudinal study of neurotrophic, oxidative, and inflammatory markers in first-onset depression in midlife women.

Eur Arch Psychiatry Clin Neurosci 2018 Dec 26;268(8):771-781. Epub 2017 May 26.

Women's Health Concerns Clinic, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.

Prospective studies have shown during the years preceding and following menopause, also known as "menopause transition", that midlife women are at higher risk for developing first-onset major depressive disorder (MDD). The biological factors associated with risk and resilience in this population are, however, largely unknown. Considering the growing body of evidence suggesting that inflammation, oxidative stress, and brain-derived neurotrophic factor (BDNF) are associated with the pathophysiology of MDD, we investigated serum levels of protein carbonyl, lipid peroxidation (thiobarbituric acid reactive substances-TBARS), thiol group content, BDNF, 3-nitrotyrosine, and heat shock protein 70 (HSP70) in a longitudinal cohort of first-onset MDD. One hundred and forty-eight women from the Harvard Study of Moods and Cycles, a prospective study of midlife women monitored throughout the transition to menopause, were studied. Within- and between-groups analyses of these peripheral markers were conducted in 37 women who developed and 111 women that did not develop MDD during the 3-year follow-up period. In women who developed MDD, HSP70 and 3-nitrotyrosine were elevated at baseline, whereas TBARS were elevated 6 months prior to development of MDD, as compared to those who did not develop MDD. Within-group analyses showed that HSP70, 3-nitrotyrosine, and BDNF decreased over time, whereas protein carbonyl was elevated only at 12 months prior to development of MDD. In women who did not develop MDD, HSP70 and thiol decreased over time. The development of MDD in midlife women may be associated with a systemic cascade of pro-oxidative and pro-inflammatory events including increased HSP70, 3-nitrotyrosine, protein carbonyl, and lipid peroxidation and decreased BDNF.
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http://dx.doi.org/10.1007/s00406-017-0812-zDOI Listing
December 2018

Prospective Longitudinal Study of Predictors of Postpartum-Onset Depression in Women With a History of Major Depressive Disorder.

J Clin Psychiatry 2017 Sep/Oct;78(8):1110-1116

Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at University of California, Los Angeles, California, USA.

Objective: Risk factors for postpartum depression in euthymic pregnant women with histories of major depressive disorder (MDD) were evaluated.

Methods: From April 2003 to March 2009, 343 pregnant women with a history of Structured Clinical Interview for DSM-IV (SCID)-diagnosed major depressive disorder were prospectively assessed from the third trimester into the postpartum period using the SCID mood module and 17-item Hamilton Depression Rating Scale (HDRS). Data from 300 subjects who completed at least 2 mood module assessments (1 within 60 days before and the other within 60 days after delivery) were analyzed for predictive associations between variables assessed in the third trimester and the development of a postpartum depression.

Results: The majority of women were euthymic in pregnancy by SCID criteria. Women with third trimester SCID-diagnosed depression (n = 45) versus euthymia (n = 255) had a significantly higher risk for having depression after delivery (24% vs 11%, P = .013). For pregnant euthymic women, third trimester total HDRS scores significantly predicted postpartum depression (P < .0001); specifically, scores on 3 HDRS items alone-work activities, early insomnia, and suicidality-significantly predicted postpartum depression. Antidepressant use in the third trimester in euthymic women did not confer protection against the onset of postpartum depression.

Conclusions: Among women with a history of MDD who are euthymic in the third trimester, 3 HDRS items-work activities, early insomnia, and suicidality-may be useful as screening items for clinicians working with pregnant women with histories of MDD to identify a group at risk for developing postpartum depression. Additionally, in euthymic women with a history of MDD, antidepressant use in the third trimester may not reduce the risk of developing postpartum depression.
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http://dx.doi.org/10.4088/JCP.15m10427DOI Listing
November 2017

Neurodevelopmental Implications of Fetal Exposure to Selective Serotonin Reuptake Inhibitors and Untreated Maternal Depression: Weighing Relative Risks.

JAMA Psychiatry 2016 11;73(11):1170-1172

Ammon-Pinizzotto Center for Women's Mental Health, Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston.

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http://dx.doi.org/10.1001/jamapsychiatry.2016.2705DOI Listing
November 2016

Independent Contributions of Nocturnal Hot Flashes and Sleep Disturbance to Depression in Estrogen-Deprived Women.

J Clin Endocrinol Metab 2016 10 28;101(10):3847-3855. Epub 2016 Sep 28.

Department of Psychiatry (H.J., S.K., J.C.), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115; Department of Psychosocial Oncology and Palliative Care (H.J.), Dana Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts 02215; Department of Psychiatry (H.J., M.P.F., N.E., L.S.C.), Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts 02114; Department of Medicine (S.L.C.), Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, Worcester, Massachusetts 01655; Division of Sleep Medicine (D.P.W.), Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115; Sleep Division, Department of Neurology (M.T.B.), and Reproductive Endocrine Unit, Department of Medicine (J.E.H.), Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts 02114; and National Institute of Environmental Health Sciences (J.E.H.), National Institutes of Health, Research Triangle Park, North Carolina 27709.

Context: Women are at increased risk for mood disturbance during the menopause transition. Hot flashes (HFs), sleep disruption, and fluctuating estradiol levels correlate with menopause-associated depression but co-occur, making cause and effect relationships difficult to disentangle.

Objective: Using a GnRH agonist (GnRHa) experimental model, we investigated whether depressive symptoms are associated with HFs and/or are explained by concomitant sleep fragmentation in the absence of estradiol fluctuation.

Design And Intervention: Depressive symptoms, objective polysomnographic sleep parameters, subjective sleep quality, serum estradiol, and HFs were assessed before and 4 weeks after open-label depot GnRHa (leuprolide 3.75-mg) administration.

Setting: Academic medical center.

Participants: Twenty-nine healthy nondepressed premenopausal volunteers (mean age, 27.3 years).

Results: Serum estradiol was rapidly and uniformly suppressed. HFs developed in 69% of the subjects. On univariate analysis, worsening of mood was predicted by increases in time in light sleep (stage N1), number of transitions to wake, non-REM arousals, subjective sleep quality, and reductions in perceived sleep efficiency (all P < .045), as well as the number of nighttime (P = .006), but not daytime (P = .28), HFs reported. In adjusted models, the number of nighttime HFs reported, increases in non-REM arousals, time in stage N1, transitions to wake, and reduced sleep quality remained significant predictors of mood deterioration (P ≤ .05).

Conclusions: Depressive symptoms emerged after estradiol withdrawal in association with objectively and subjectively measured sleep disturbance and the number of nighttime, but not daytime, HFs reported. Results suggest that sleep disruption and perceived nighttime HFs both contribute to vulnerability to menopause-associated depressive symptoms in hypoestrogenic women.
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http://dx.doi.org/10.1210/jc.2016-2348DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5052351PMC
October 2016