Aripiprazole once-monthly is a long-acting intramuscular injectable formulation of aripiprazole. The starting dose can be administered by following one of two regimens: • One injection start: On the day of initiation, administer one injection of 400 mg Aripiprazole once monthly and continue treatment with 10 mg to 20 mg oral aripiprazole per day for 14 consecutive days • Two injection start (New regimen): On the day of initiation, administer two separate injections of 400 mg Aripiprazole once monthly at separate injection sites, along with one 20 mg dose of oral aripiprazole.

To assess the effectiveness and tolerability of Aripiprazole long-acting injectable (ALAI) in patients with schizophrenia. The starting dose was administered following the two injection start regimen

Sample:10 patients with schizophrenia (DSM 5 criteria) who started treatment with ALAI. The starting dose was administered following the two injection start regimen. On a tri-monthly basis, the following evaluations were performed during a follow-up period of 6 months: The Clinical Global Impression-Schizophrenia scale (CGI-SCH), treatment adherence, the number of hospitalizations and Side effects reported

Mean variations from baseline scores at 6 months was (-1.1 ±0.89) on the GCI-SCH. The percentage of patients who remained free of admissions at the end of the 6 months was 90%. The rate of adherence to treatment after 6 months was 80%. The most frequent side effect was transient mild insomnia (20%) .

Aripiprazole long-acting injectable (The starting dose was administered following the two injection start regimen) is effective, safe and well tolerated in clinical practice conditions

No significant relationships.

Noninterventional naturalistic studies are an important complement to randomized controlled trials. Aripiprazole once-monthly (AOM) is an atypical antipsychotic in a long-acting injectable formulation.

A pooled analysis of two noninterventional studies was undertaken to validate previous results on AOM effectiveness and safety in a larger population and improve statistical power for preplanned subgroup analyses. We analyzed data from 409 patients with schizophrenia who were treated with AOM and were enrolled in noninterventional studies in Germany (via noninterventional studies registry 15,960 N) and Canada (NCT02131415). Data collected at baseline, 3 and 6 months were analyzed. Among the endpoints were psychopathology (brief psychiatric rating scale [BPRS]) and disease severity (clinical global impression [CGI]).

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). A total of 54.4% were responders (at least 20% reduction) on the BPRS, and 56.5% had a CGI-S-score that was at least 1 level better than baseline. A total of 43.4% were considered responders on both the BPRS and CGI scales. A total of 45.2% were considered in remission. Adverse events were rare and corresponded to the previously known safety profile of AOM.

Treatment with AOM for patients with schizophrenia appeared effective and safe under real-life conditions.

To assess the effects of aripiprazole once-monthly 400 mg (AOM 400) on clinical symptoms and global improvement in schizophrenia after switching from an oral antipsychotic.

In a multicenter, open-label, mirror-image, naturalistic study in patients with schizophrenia (>1 year, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision [DSM-IV-TR] criteria), changes in efficacy measures were assessed during prospective treatment (6 months) with AOM 400 after switching from standard-of-care oral antipsychotics. During prospective treatment, patients were cross-titrated to oral aripiprazole monotherapy (1–4) weeks followed by open-label AOM 400 (24 weeks). Mean change from baseline of the open-label AOM 400 phase in Positive and Negative Syndrome Scale (PANSS) scores (total, positive and negative subscales) and Clinical Global Impression–Severity (CGI-S) scores; mean CGI–Improvement (CGI-I) score; and proportion of responders (≥30% decrease from baseline in PANSS total score or CGI-I score of 1 [very much improved] or 2 [much improved]) were assessed.

PANSS and CGI-S scores improved from baseline (P<0.0001) and CGI-I demonstrated improvement at all time points. By the end of the study, 49.0% of patients were PANSS or CGI-I responders.

In a community setting, patients with schizophrenia who were stabilized at baseline and switched to AOM 400 from oral antipsychotics showed clear improvements in clinical symptoms.