Abstract
BackgroundWith 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.MethodsFollowing 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.ResultsA 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.ConclusionsTreatment 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 registrationUnique identifier: NCT02131415. First posted: 06 May 2014.
Highlights
With previously established efficacy of aripiprazole once-monthly injectable formulation (AOM) in preregistration randomized controlled trials, the current study was designed to evaluate its effectiveness in patients treated for schizophrenia in regular clinical settings in Canada
Adherence with the prescribed treatment while patients were on treatment was high with a mean of 1.04 injections administered per month, Additional file 1: Table S1
At month-12, significant (≥7%) weight gain was observed in 25.7% (n = 27/105) of patients with no difference between groups; early psychosis: 27.1% (n = 19/70) and late psychosis: 22.9% (n = 8/35)
Summary
With previously established efficacy of aripiprazole once-monthly injectable formulation (AOM) in preregistration randomized controlled trials, the current study was designed to evaluate its effectiveness in patients treated for schizophrenia in regular clinical settings in Canada. For a durable symptomatic remission, adequate antipsychotic medication is combined with evidence based psychosocial interventions [1]. Long periods of remission are almost necessary for a good functional outcome [2]. Relapse, which interrupts periods of remission, has serious consequences for the patient and the healthcare system [3, 4]. Relapse is predicted strongly by non-adherence to medication, substance abuse, poor pre-morbid adjustment and stress, especially in the early phase of the illness [5]. There is mounting recent evidence that long acting injectable (LAI) antipsychotics improve adherence primarily through more accurate monitoring at all stages of illness, including the “critical phase” of the first 2 to 5 years [6,7,8,9,10]
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