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. Electronic supplementary material The online version of this article (10.1186/s12888-019-2103-x) contains supplementary material, which is available to authorized users.

Background: Non-interventional naturalistic studies are an important complement to randomized controlled trials. Aripiprazole once-monthly (AOM) is an atypical antipsychotic in a long-acting injectable formulation.Methods: A pooled analysis of 2 non-interventional studies was undertaken to validate previous results on AOM effectiveness and safety in a larger population and improve statistical power for pre-planned subgroup analyses. We analyzed data from 409 patients with schizophrenia who were treated with AOM and were enrolled in non-interventional studies in Germany (vfa non-interventional studies registry 15960N) and Canada (NCT02131415). Data collected at baseline, 3 months and 6 months were analyzed.Among the endpoints were psychopathology (Brief Psychiatric Rating Scale, BPRS) and disease severity (Clinical Global Impression, CGI).Results: Mean patient age was 38.9 (SD 14.8) years, and 59.9% were male. BPRS decreased from 48.1 (SD 15.6) at baseline to 36.5 (SD 13.7) at month 6 (p < 0.001). CGI decreased from 4.47 (SD 0.90) at baseline to 3.64 (SD 1.16) at month 6 (p < 0.001). 54.4% were responders (at least 20% reduction) on the BPRS, and 56.4% had a CGI-S-score that was at least 1 level better than baseline. 43.4% were considered responders on both the BPRS and CGI scales. 45.2% were considered in remission. Adverse events were rare and corresponded to the previously known safety profile of AOM.Conclusions: Treatment with AOM for patients with schizophrenia appeared effective and safe under real-life conditions.

Objective: To assess changes in workplace productivity and functioning in an open-label study in working patients receiving vortioxetine (10 to 20 mg/d) for major depressive disorder (MDD). Methods: Associations between items in the Work Limitations Questionnaire (WLQ), the Sheehan Disability Scale (SDS), and the Work Productivity and Activity Impairment (WPAI) questionnaire were assessed at 12 and 52 weeks by Pearson correlation coefficients. Results: Significant improvements were observed across all domains of workplace productivity and functioning after 12 and 52 weeks’ vortioxetine treatment. Strong correlations were seen between improvements in WLQ mental domains and WPAI presenteeism and SDS work/school items. Presenteeism showed stronger correlations with other workplace productivity measures than absenteeism. Conclusions: Presenteeism and absenteeism impact productivity in working patients with MDD. Vortioxetine confers long-term benefits across all workplace functioning domains.

Background: Anxiety symptoms are common in patients with major depressive disorder (MDD) and usually confer worse treatment outcomes. The long-term, open-label AtWoRC study in working patients with MDD treated with vortioxetine demonstrated a significant correlation between severity of anxiety symptoms and impaired work productivity. This analysis was undertaken to further explore clinical characteristics and treatment outcomes in patients with different levels of severity of anxiety symptoms at baseline. Methods: Post hoc analysis in 199 working patients with MDD treated with vortioxetine (10–20 mg/day), stratified by Generalized Anxiety Disorder 7-item (GAD-7) score at baseline [mild/moderate anxiety (GAD-7 ⩽14), n = 83; severe anxiety (GAD-7 ⩾15), n = 116]. Associations were examined between GAD-7 and other outcome assessment scores at baseline. Observed mean changes from baseline to week 52 were compared between groups. Results: Patients with severe anxiety had significantly worse depressive and cognitive symptoms, functioning, and work productivity at baseline than those with mild/moderate anxiety, but similar cognitive performance. Statistically significant improvements from baseline were seen for all outcomes after 52 weeks of vortioxetine treatment, with no significant differences observed between the two groups after adjustment for baseline anxiety scores. Conclusion: Treatment with vortioxetine was associated with long-term improvement in clinical symptoms and measures of work productivity in patients with MDD in a real-world setting, irrespective of severity of anxiety symptoms at the start of treatment.

Background ReLiAM, Real-Life Assessment of Abilify Maintena, was the first reported long-term prospective non-interventional study for patients with schizophrenia treated with aripiprazole once-monthly injectable formulation (AOM) under real-life conditions. ReLiAM’s primary aim was to evaluate the evolution of global functional status in patients treated with AOM for 12 months in Canada. Methods The objective of this post hoc analysis of the ReLiAM study is to investigate the treatment effects of real-life use of AOM over a 1-year period in the subgroup of patients with reported substance use compared with patients without substance use. Results The results of this post hoc analysis demonstrate that treatment with AOM for 12 months in patients with schizophrenia was comparably effective in improving global functioning in subgroups of patients with and without concomitant substance use. Conclusions These results support the use of AOM for the treatment of schizophrenia in patients with or without concomitant substance use. Trial registration ClinicalTrials.gov NCT02131415, first posted on May 6, 2014. Overall trial status: Terminated.