Real-life assessment of aripiprazole monthly (Abilify Maintena) in schizophrenia: a Canadian naturalistic non-interventional prospective cohort study.

Authors:
Sally Mustafa
Sally Mustafa
The University of British Columbia
Vancouver | Canada
Joanna Bougie
Joanna Bougie
2Lundbeck Canada Inc.
Maia Miguelez
Maia Miguelez
Ottawa Hospital Eye Institute
Canada
Guerline Clerzius
Guerline Clerzius
Lady Davis Institute for Medical Research
Canada
Emmanouil Rampakakis
Emmanouil Rampakakis
McGill University
Canada
Jean Proulx
Jean Proulx
University of Montreal
Canada
Ashok Malla
Ashok Malla
McGill University
Montréal | Canada

BMC Psychiatry 2019 Apr 16;19(1):114. Epub 2019 Apr 16.

Douglas Mental Health University Institute, Montreal, Quebec, Canada.

Background: With previously established efficacy of aripiprazole once-monthly injectable formulation (AOM) in pre-registration randomized controlled trials, the current study was designed to evaluate its effectiveness in patients treated for schizophrenia in regular clinical settings in Canada.

Methods: Following their clinicians' decision to prescribe AOM, 193 patients with a diagnosis of schizophrenia, were recruited from 17 Canadian community or hospital-based settings. The primary outcome of global functioning was assessed with the Global Assessment of Functioning Scale (GAF) at 3-month intervals for 1 year. Secondary outcomes (social and occupational functioning and illness severity) and adverse drug reactions (ADR) were also assessed.

Results: A majority of the 169 evaluable patients were within the first 5 years of diagnosis (early phase). A linear mixed model analysis showed a significant main effect of time (Type III test p < 0.001) after adjusting for baseline GAF score, with a change in mean GAF scores from 49 at baseline to 61 at 12 months. No differences between early vs late phase were observed. Results on secondary outcome measures of function (Social and Occupational Functioning Scale) and illness severity (Clinical Global Impression-Severity Scale and Brief Psychiatric Rating Scale) were similar. Serious ADRs were observed in 29 (14.6%) patients and akathisia in 18 (9.1%) patients. At month-12, significant (≥7%) weight gain was observed in 25.7% (n = 27/105) of patients.

Conclusions: Treatment with AOM is effective in improving symptoms and functioning in schizophrenia patients treated in regular clinical settings. Akathisia was infrequent while one quarter of patients gained clinically significant weight.

Trial Registration: Unique identifier: NCT02131415 . First posted: 06 May 2014.

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http://dx.doi.org/10.1186/s12888-019-2103-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6469112PMC
April 2019
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