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

Sally Mustafa, Joanna Bougie, Maia Miguelez, Guerline Clerzius, Emmanouil Rampakakis, Jean Proulx, Ashok Malla, Sally Mustafa, Joanna Bougie, Maia Miguelez, Guerline Clerzius, Emmanouil Rampakakis, Jean Proulx, Ashok Malla

Abstract

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.

Keywords: Adherence; Aripiprazole once-monthly; Global functioning; Long acting injectable antipsychotics; Schizophrenia.

Conflict of interest statement

Ethics approval and consent to participate

All patients signed an informed consent before any study related procedures were performed. Central Ethics approval was obtained from IRB Services, Aurora, Ontario, Canada. In addition, approval from local institutional ethics boards (University of Windsor, McGill University Health Centre, Institut Universitaire en Santé Mentale de Québec, Capital Health, Ottawa Health Science Network, Royal Ottawa Health Care Group, University of Calgary, Western University, Queen’s University, Douglas Mental Health University Institute, University of British Columbia) was obtained as required.

Consent for publication

Not applicable.

Competing interests

Dr. Malla is personally supported by Canada Research Chairs program. He was not involved in patient recruitment or in clinical care of the patients who participated in this study. In addition, to research funding from peer reviewed granting agencies, he reports research funding for an investigator-initiated project (2011–2014), unrelated to the present study report, from BMS Canada; honoraria for lectures delivered at conferences and for consultations on research sponsored by Otsuka and Lundbeck, Canada and Global and consulting activities with Otsuka and Lundbeck. Sally Mustafa was supported by a grant from Lundbeck Canada Inc. and Otsuka Canada Pharmaceutical Inc. Joanna Bougie, Guerline Clerzius and Jean Proulx are employees of Lundbeck Canada. Maia Miguelez is an employee of Otsuka Canada Pharmaceutical. Emmanouil Rampakakis is an employee of JSS Medical Research, the contract research organization mandated to manage the study.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Consort flow diagram
Fig. 2
Fig. 2
Mean change in Global Assessment of Functioning (GAF) from baseline to month 12 (mean baseline GAF score for whole sample = 48.7, early psychosis = 49.1, late psychosis = 48.5)

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