Publications by authors named "Alla Avedisova"

9 Publications

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Validation of the Generalized Anxiety Disorder-7 (GAD-7) in Russian people with epilepsy.

Epilepsy Behav 2021 10 6;123:108269. Epub 2021 Sep 6.

Moscow Research and Clinical Center for Neuropsychiatry, Moscow, Russian Federation; Pirogov Russian National Research Medical University, Moscow, Russian Federation.

Objective: To assess the capacity of Generalized Anxiety Disorder-7 (GAD-7) to detect anxiety disorders in a Russian sample of patients with epilepsy and to validate this instrument for rapid screening of anxiety in these patients.

Methods: Study included 233 patients with epilepsy, both inpatients and outpatients. For all patients Mini-International Neuropsychiatric Interview was conducted as a gold standard for diagnosis of mental disorders. All patients also completed the questionnaires - the Russian version of GAD-7 and Hospital Anxiety and Depression Scale (HADS) to assess convergent validity. Chi-square and Fisher's exact tests were used to compare categorical variables, and the Mann-Whitney test was used for the quantitative ones. Internal consistency was assessed using Cronbach's alpha, Cronbach's alpha at point deletion, and corrected point-to-point correlation. ROC analysis was used to evaluate the properties of the GAD-7 to determine anxiety disorders.

Results: Among 97 (41.6%) patients with epilepsy diagnosed with any anxiety disorders, 42 (18%) had panic disorder, 37 (15.9%) had agoraphobia, 17 (7.3%) had social anxiety disorder, and 64 (27.5%) had generalized anxiety disorder; 42 patients (18%) showed a combination of several anxiety disorders. The overall GAD-7 score was similar to other epilepsy studies, but higher cutoff scores characterize our sample. The scale performed well in detecting any anxiety disorder with the AUC of 0.866 and the optimal cutoff point > 8 points, and in detecting GAD with AUC = 0.922 and the optimal cutoff point > 9 points, showing overall acceptable sensitivity.

Conclusion: Russian version of the GAD-7 could be used as a screening tool for any anxiety disorders in PWE with the optimal cutoff score > 8 points.
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http://dx.doi.org/10.1016/j.yebeh.2021.108269DOI Listing
October 2021

Validation of the Generalized Anxiety Disorder-7 (GAD-7) in Russian people with epilepsy.

Epilepsy Behav 2021 10 6;123:108269. Epub 2021 Sep 6.

Moscow Research and Clinical Center for Neuropsychiatry, Moscow, Russian Federation; Pirogov Russian National Research Medical University, Moscow, Russian Federation.

Objective: To assess the capacity of Generalized Anxiety Disorder-7 (GAD-7) to detect anxiety disorders in a Russian sample of patients with epilepsy and to validate this instrument for rapid screening of anxiety in these patients.

Methods: Study included 233 patients with epilepsy, both inpatients and outpatients. For all patients Mini-International Neuropsychiatric Interview was conducted as a gold standard for diagnosis of mental disorders. All patients also completed the questionnaires - the Russian version of GAD-7 and Hospital Anxiety and Depression Scale (HADS) to assess convergent validity. Chi-square and Fisher's exact tests were used to compare categorical variables, and the Mann-Whitney test was used for the quantitative ones. Internal consistency was assessed using Cronbach's alpha, Cronbach's alpha at point deletion, and corrected point-to-point correlation. ROC analysis was used to evaluate the properties of the GAD-7 to determine anxiety disorders.

Results: Among 97 (41.6%) patients with epilepsy diagnosed with any anxiety disorders, 42 (18%) had panic disorder, 37 (15.9%) had agoraphobia, 17 (7.3%) had social anxiety disorder, and 64 (27.5%) had generalized anxiety disorder; 42 patients (18%) showed a combination of several anxiety disorders. The overall GAD-7 score was similar to other epilepsy studies, but higher cutoff scores characterize our sample. The scale performed well in detecting any anxiety disorder with the AUC of 0.866 and the optimal cutoff point > 8 points, and in detecting GAD with AUC = 0.922 and the optimal cutoff point > 9 points, showing overall acceptable sensitivity.

Conclusion: Russian version of the GAD-7 could be used as a screening tool for any anxiety disorders in PWE with the optimal cutoff score > 8 points.
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http://dx.doi.org/10.1016/j.yebeh.2021.108269DOI Listing
October 2021

Effect of agomelatine 25-50 mg on functional outcomes in patients with major depressive disorder.

J Affect Disord 2018 10 29;238:122-128. Epub 2018 May 29.

Institut de Recherches Internationales Servier (IRIS), 50 rue Carnot, Suresnes Cedex 92284, France.

Purpose: The purpose of this work is to investigate the effect of agomelatine on functioning compared with placebo in patients suffering from Major Depressive Disorder (MDD).

Methods: Data from two randomized, parallel, double-blind, placebo-controlled short-term agomelatine trials conducted by the manufacturer, one in adult and one in older patients, that evaluated the effect on social functioning, were pooled. The short term effect of agomelatine on social functioning was assessed using the Sheehan Disability Scale (SDS), according to SDS total and sub-item scores, as well as on functional response and remission rates. The Hamilton Depression rating scale was used to quantify severity of depression symptoms. A meta-analytic method using a random effect model was used to assess differences in treatment.

Results: In total, 633 patients (422 on agomelatine; 211 on placebo) were included in the analyses. At endpoint, there was a significant difference in favor of agomelatine vs placebo of 3.47 (0.62) (95% confidence interval: [2.26; 4.67]; P < 0.001) on the SDS total score. Rates of symptomatic response and remission according to HAM-D total score were significantly higher in patients taking agomelatine (54.3% and 18.3% respectively) than in those taking placebo (29.4% and 9.5% respectively) with respective differences of 24.9%, p < 0.001 and 9.3%, p < 0.001. The functional response rates were 52.9% on agomelatine and 34.5% on placebo, with a significant placebo-agomelatine difference in favor of agomelatine of 18.30 ± 4.39% (95% CI: [9.69; 26.91], p < 0.001). The functional remission rates were 22.3% with agomelatine and 10.2% with placebo, with a significant difference in favor of agomelatine of 11.7 ± 3.11% (95% CI: [5.61; 17.79], p < 0.001). Combined symptomatic and functional response rates were 42.1% on agomelatine and 23.2% on placebo (p < 0.001), and the combined symptomatic and functional remission rates were 13.9% on agomelatine and 6.8% on placebo (p < 0.005).

Conclusion: This study confirms the efficacy of agomelatine in improving social functioning in MDD patients.
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http://dx.doi.org/10.1016/j.jad.2018.05.060DOI Listing
October 2018

Efficacy and safety of agomelatine (10 or 25 mg/day) in non-depressed out-patients with generalized anxiety disorder: A 12-week, double-blind, placebo-controlled study.

Eur Neuropsychopharmacol 2017 05 12;27(5):526-537. Epub 2017 Mar 12.

Institut de Recherches Internationales Servier (IRIS), 50 rue Carnot, 92284 Suresnes Cedex, France.

Agomelatine is efficacious in reducing symptoms and preventing relapse in placebo-controlled trials in generalised anxiety disorder (GAD). Nevertheless, fixed dose studies of agomelatine in GAD have not been undertaken. To determine the minimally effective optimal dose of agomelatine in GAD, the efficacy of two doses of agomelatine (10 and 25mg/day) was investigated in a 12-week, placebo-controlled, double-blind, international study in patients with a primary diagnosis of GAD. The primary outcome measure was the Hamilton Anxiety scale (HAM-A). The study was undertaken in 35 clinical centers in Finland, Russia, Poland, Slovakia and Ukraine from August 2013 to January 2015. 131 out-patients were included in the agomelatine 10mg group, 139 in the agomelatine 25mg group, and 142 in the placebo group. Both doses of agomelatine were associated with significant decreases in the HAM-A at week 12 (difference versus placebo of 7.16±1.00 at 10mg and 11.08±0.98 at 25mg, p<0.0001). Significant effects on all secondary measures were found for both doses at week 12; including psychic and somatic HAM-A subscales, response rate, remission on the HAM-A, and functional impairment. Findings were confirmed in subsets of more severely ill patients on all endpoints. The low placebo response rate observed in this study was consistent with an increase in the quality of data collected. Agomelatine was well-tolerated by patients, with minimal distinctions from placebo. There was a dose effect of agomelatine, with a greater placebo-agomelatine difference in the agomelatine 25mg group, compared to the agomelatine 10mg group.The present data support early work indicating the efficacy and tolerability of agomelatine in the treatment of GAD.
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http://dx.doi.org/10.1016/j.euroneuro.2017.02.007DOI Listing
May 2017

Sustained efficacy of agomelatine 10 mg, 25 mg, and 25-50 mg on depressive symptoms and functional outcomes in patients with major depressive disorder. A placebo-controlled study over 6 months.

Eur Neuropsychopharmacol 2016 Feb 25;26(2):378-389. Epub 2015 Sep 25.

Institut de Recherches Internationales Servier (IRIS), 50 rue Carnot, 92284 Suresnes Cedex, France.

This randomized placebo-controlled "dose relation study" was conducted in patients who met criteria for major depressive disorder, to evaluate the efficacy and safety of agomelatine during 24 weeks at 3 doses (i) low fixed dosage (10 mg/day, n=100 patients entered the extension period), (ii) fixed dosage (25 mg/day, n=111) and (iii) a flexible dosage with up-titration in case of insufficient improvement at week 2 (25-50 mg/day, n=115) versus placebo (n=85). Mood was evaluated using the Hamilton rating scale for depression (HAM-D17) and Clinical Global Impression (CGI) scale. The functional status was examined with the Sheehan Disability Scale (SDS). At last post-baseline assessment, there were significant placebo-agomelatine differences on mean HAM-D17 total scores in favour of each agomelatine dose regimen (4.51±1.06 points, p<0.0001 at 10 mg; 7.74±1.05 points, p<0.0001 at 25 mg and 7.72±1.05 points, p<0.0001 at 25-50 mg). The response rate according to HAM-D17 was significantly higher in patients taking agomelatine than those taking placebo (difference of 21.8% at 10mg p<0.001; 36.4% and 35.4% respectively at 25 mg and 25-50 mg, p<0.0001). The remitter rate was significantly higher in patients taking agomelatine than those taking placebo (difference of 16.7% at 10 mg p=0.003; 33.8% and 35.4% respectively at 25 mg and 25-50 mg, p<0.0001). The effects of agomelatine were corroborated by CGI scores. Agomelatine improved symptom-related functional impairment on all domains of the SDS scale for the fixed dose 25 mg, and the one step titration 25-50 mg dose regimen. Similar findings were obtained for all measures in the subgroup of severely depressed patients. All dose regimens of agomelatine were well tolerated and no unexpected adverse event was reported. Long term agomelatine treatment improves both mood symptoms and social and occupational functioning of moderately to severely depressed patients. There is a dose effect between 10 mg and higher dose regimens of agomelatine. The threshold dose of 25 mg for initiating treatment can be maintained over 6 months in depressed patients.
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http://dx.doi.org/10.1016/j.euroneuro.2015.09.006DOI Listing
February 2016

Agomelatine in generalized anxiety disorder: an active comparator and placebo-controlled study.

J Clin Psychiatry 2014 Apr;75(4):362-8

University of Cape Town Department of Psychiatry, Groote Schuur Hospital, J-Block, Anzio Rd, Observatory, Cape Town 7925, South Africa

Background: Agomelatine was efficacious in reducing symptoms in a short-term placebo-controlled trial in generalized anxiety disorder (GAD) and in preventing relapse in a longer term placebo-controlled study. An additional short-term placebo-controlled study is required by regulatory agencies to confirm the efficacy of agomelatine in GAD.

Method: This 12-week, placebo-controlled, double-blind, randomized, parallel group, international, multicenter study was designed to confirm the efficacy of agomelatine 25-50 mg/d in the treatment of patients with a primary DSM-IV-TR diagnosis of GAD. The primary outcome measure was the Hamilton Anxiety Rating Scale (HARS) total score. Assay sensitivity was evaluated by including an escitalopram (10-20 mg/d) group.

Settings: The study was undertaken in 45 clinical centers in Argentina, Czech Republic, Finland, South Korea, Poland, Russia, and Slovakia from April 2010 to July 2011.

Results: One hundred thirty-nine outpatients were included in the agomelatine group, 131 in the placebo group, and 142 in the escitalopram group. Agomelatine significantly reduced mean (SD) HARS total score (agomelatine-placebo difference: 4.71 [1.03], P <.0001) and had significant effects on secondary outcome measures, including psychic and somatic HARS subscales, response rate (estimate [standard error]) (agomelatine-placebo difference: 27.4% [5.9%], P< .0001), remission on the HARS (agomelatine-placebo difference: 16.8% [5.4%], P = .002), Clinical Global Impressions-Severity of Illness scale (CGI-S) (P < .001), functional impairment (P < .0001), and sleep quality (P < .001). Findings were confirmed in the subset of more severely ill patients (HARS total score ≥ 25 with or without CGI-S ≥ 5 at baseline). Agomelatine was well tolerated by patients, with no more adverse events than placebo. Escitalopram was similarly efficacious but was accompanied by a higher incidence of adverse events compared to placebo.

Conclusions: In clinical practice, agomelatine has at least similar efficacy to that of escitalopram for the short-term treatment of GAD and is well tolerated.

Trial Registration: Controlled-Trials.com identifier: ISRCTN03554974.
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http://dx.doi.org/10.4088/JCP.13m08433DOI Listing
April 2014

A placebo-controlled study of three agomelatine dose regimens (10 mg, 25 mg, 25-50 mg) in patients with major depressive disorder.

Eur Neuropsychopharmacol 2014 Apr 31;24(4):553-63. Epub 2014 Jan 31.

Institut de Recherches Internationales Servier (IRIS), 50 rue Carnot, 92284 Suresnes Cedex, France.

A randomised placebo-controlled "dose relation study" was conducted in 549 patients who met the criteria for major depressive disorder, to evaluate the efficacy and safety of three doses regimens of agomelatine during 6 weeks: low fixed dosage (10 mg/day, n=133), fixed dosage (25 mg/day, n=138) and a flexible dosage with up-titration in case of insufficient improvement at week 2 (25-50 mg/day, n=137). At last post-baseline assessment, there were significant and incremental placebo-agomelatine differences on mean HAM-D₁₇ total scores in favour of each agomelatine dose regimen (2.46 ± 0.76 points, p=0.001 at 10 mg; 4.71+0.75 points, p<0.0001 at 25 mg and 4.92 ± 0.76 points, p<0.0001 at 25-50 mg) with statistically significant differences between 25 mg and 25-50 mg dose regimens compared to the 10 mg dose. The response rate according to HAM-D₁₇ was significantly higher in patients taking agomelatine than those taking placebo (difference of 16.1% at 10 mg p=0.005; 25.9% and 27.4% respectively at 25 mg and 25-50 mg, p<0.0001). The benefit of agomelatine was demonstrated in the subgroup of severely depressed patients in the 25 mg and 25-50 mg/day regimens. Consistent clinical response according to CGI variables and better social functioning were found in patients receiving agomelatine. All dose regimens of agomelatine were well tolerated and no unexpected adverse event was reported. This study provides evidence of a dose effect for agomelatine between 10 mg and the therapeutic dose regimen of agomelatine 25-50 mg: the efficacy of the higher dose regimens being more efficacious than the lowest (10 mg) daily dose. The data support a definitive statement regarding the utility of 25 mg as the threshold dose for initiating agomelatine in depressed patients.
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http://dx.doi.org/10.1016/j.euroneuro.2014.01.006DOI Listing
April 2014

A placebo-controlled study of three agomelatine dose regimens (10 mg, 25 mg, 25-50 mg) in patients with major depressive disorder.

Eur Neuropsychopharmacol 2014 Apr 31;24(4):553-63. Epub 2014 Jan 31.

Institut de Recherches Internationales Servier (IRIS), 50 rue Carnot, 92284 Suresnes Cedex, France.

A randomised placebo-controlled "dose relation study" was conducted in 549 patients who met the criteria for major depressive disorder, to evaluate the efficacy and safety of three doses regimens of agomelatine during 6 weeks: low fixed dosage (10 mg/day, n=133), fixed dosage (25 mg/day, n=138) and a flexible dosage with up-titration in case of insufficient improvement at week 2 (25-50 mg/day, n=137). At last post-baseline assessment, there were significant and incremental placebo-agomelatine differences on mean HAM-D₁₇ total scores in favour of each agomelatine dose regimen (2.46 ± 0.76 points, p=0.001 at 10 mg; 4.71+0.75 points, p<0.0001 at 25 mg and 4.92 ± 0.76 points, p<0.0001 at 25-50 mg) with statistically significant differences between 25 mg and 25-50 mg dose regimens compared to the 10 mg dose. The response rate according to HAM-D₁₇ was significantly higher in patients taking agomelatine than those taking placebo (difference of 16.1% at 10 mg p=0.005; 25.9% and 27.4% respectively at 25 mg and 25-50 mg, p<0.0001). The benefit of agomelatine was demonstrated in the subgroup of severely depressed patients in the 25 mg and 25-50 mg/day regimens. Consistent clinical response according to CGI variables and better social functioning were found in patients receiving agomelatine. All dose regimens of agomelatine were well tolerated and no unexpected adverse event was reported. This study provides evidence of a dose effect for agomelatine between 10 mg and the therapeutic dose regimen of agomelatine 25-50 mg: the efficacy of the higher dose regimens being more efficacious than the lowest (10 mg) daily dose. The data support a definitive statement regarding the utility of 25 mg as the threshold dose for initiating agomelatine in depressed patients.
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http://dx.doi.org/10.1016/j.euroneuro.2014.01.006DOI Listing
April 2014

Activation of mGlu2/3 receptors as a new approach to treat schizophrenia: a randomized Phase 2 clinical trial.

Nat Med 2007 Sep 2;13(9):1102-7. Epub 2007 Sep 2.

Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285, USA.

Schizophrenia is a chronic, complex and heterogeneous mental disorder, with pathological features of disrupted neuronal excitability and plasticity within limbic structures of the brain. These pathological features manifest behaviorally as positive symptoms (including hallucinations, delusions and thought disorder), negative symptoms (such as social withdrawal, apathy and emotional blunting) and other psychopathological symptoms (such as psychomotor retardation, lack of insight, poor attention and impulse control). Altered glutamate neurotransmission has for decades been linked to schizophrenia, but all commonly prescribed antipsychotics act on dopamine receptors. LY404039 is a selective agonist for metabotropic glutamate 2/3 (mGlu2/3) receptors and has shown antipsychotic potential in animal studies. With data from rodents, we provide new evidence that mGlu2/3 receptor agonists work by a distinct mechanism different from that of olanzapine. To clinically test this mechanism, an oral prodrug of LY404039 (LY2140023) was evaluated in schizophrenic patients with olanzapine as an active control in a randomized, three-armed, double-blind, placebo-controlled study. Treatment with LY2140023, like treatment with olanzapine, was safe and well-tolerated; treated patients showed statistically significant improvements in both positive and negative symptoms of schizophrenia compared to placebo (P < 0.001 at week 4). Notably, patients treated with LY2140023 did not differ from placebo-treated patients with respect to prolactin elevation, extrapyramidal symptoms or weight gain. These data suggest that mGlu2/3 receptor agonists have antipsychotic properties and may provide a new alternative for the treatment of schizophrenia.
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http://dx.doi.org/10.1038/nm1632DOI Listing
September 2007
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