Trial of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in the Acute Treatment of Adults With Schizophrenia
Summary
The primary purpose of this study is to evaluate the overall efficacy of aripiprazole intramuscular (IM) depot as acute treatment in subjects with schizophrenia. The secondary purpose is to evaluate the safety and tolerability of aripiprazole IM depot administered every 4 weeks for 12 weeks to adult subjects with schizophrenia.
Timeline
- Start
- 2012-10
- Primary completion
- 2013-08
- Completion
- 2013-09
Outcome
Met primary endpoint
registry analysis (superiority or other test); Aripiprazole IM Depot 400/300mg vs Placebo; p <.0001; Mean Difference (Final Values) -15.1 (95% CI -19.4 to -10.8); NCT01663532 ↗
paper LS mean change from baseline to endpoint (week 10) favored AOM versus placebo in PANSS total (treatment difference, -15.1 [95% CI, -19.4 to -10.8]; P < .0001) PMID 25188501 ↗
release “Efficacy of Abilify Maintena (aripiprazole) for the treatment of acutely relapsed adults with schizophrenia was demonstrated in a 12-week” otsuka.co.jp ↗
release “The primary efficacy outcome was change from baseline to 10-week endpoint in PANSS total score and demonstrated greater improvement with Abilify Maintena than with placebo (-26.8 vs. -11.7, respectively, p<0.0001)” otsuka.co.jp ↗
Publications
- Citrome L, Bell Lynum KS, Zhang Z, Atkins N Jr, Hutson Walker AM, Yildirim M. Aripiprazole Once-Monthly for Patients Diagnosed With Schizophrenia: Number Needed to Treat, Number Needed to Harm, and Likelihood to be Helped or Harmed. J Clin Psychiatry. 2026 May 13;87(2):26m16359. doi: 10.4088/JCP.26m16359.
- Kane JM, Peters-Strickland T, Baker RA, Hertel P, Eramo A, Jin N, Perry PP, Gara M, McQuade RD, Carson WH, Sanchez R. Aripiprazole once-monthly in the acute treatment of schizophrenia: findings from a 12-week, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2014 Nov;75(11):1254-60. doi: 10.4088/JCP.14m09168.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aripiprazole | Other / unclassified | 400 mg | Intramuscular |