Aripiprazole for the Prevention of Relapse in Stabilized Patients With Chronic Schizophrenia: A Placebo-Controlled 26-Week Study.

BACKGROUND:

Aripiprazole is a novel antipsychotic for the management of schizophrenia. This study investigated the efficacy, safety, and tolerability of aripiprazole in preventing relapse in adult chronic schizophrenia patients experiencing ongoing stable symptomatology.

METHOD:

In this 26-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter study, 310 patients with DSM-IV schizophrenia (mean Positive and Negative Syndrome Scale [PANSS] total score=82) were randomly assigned to receive a once-daily fixed dose of aripiprazole, 15 mg, or placebo. The primary outcome measure was time to relapse following randomization. Secondary objectives were to assess the efficacy, safety, and tolerability of aripiprazole, 15 mg, compared with placebo, in the study population. The study was conducted between Dec. 21, 2000, and Aug. 20, 2001.

RESULTS:

The time to relapse following randomization was significantly (p<.001) longer for aripiprazole compared with placebo. More patients relapsed with placebo (N=85; 51%} than aripiprazole (N=50; 34%); the relative risk of relapse for the aripiprazole group was 0.59 (p<.001). Aripiprazole was significantly superior to placebo from baseline to endpoint in PANSS total... (PsycInfo Database Record (c) 2021 APA, all rights reserved)