Efficacy and Safety of Aripiprazole and Haloperidol Versus Placebo in Patients With Schizophrenia and Schizoaffective Disorder

Oct 5, 2002The Journal of clinical psychiatry

Effectiveness and safety of aripiprazole and haloperidol compared to placebo in schizophrenia and schizoaffective disorder

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Abstract

Both doses of aripiprazole (15 mg/day, 30 mg/day) and haloperidol (10 mg/day) showed statistically significant improvements in multiple psychiatric scales compared to placebo.

Both aripiprazole and haloperidol improved PANSS total and positive scores significantly from baseline.
Aripiprazole and haloperidol also resulted in significant improvements in the PANSS-derived BPRS core and CGI-Severity scores compared to placebo.
Aripiprazole, at 15 mg, and haloperidol significantly improved PANSS negative scores compared to placebo.
Aripiprazole was not associated with significant extrapyramidal symptoms or increases in serum prolactin levels, unlike haloperidol.
No significant differences in body weight changes were observed across treatment groups compared to placebo.

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BACKGROUND: Aripiprazole is an investigational agent for treating schizophrenia that has a novel pharmacologic profile. The present study investigated the efficacy, safety, and tolerability of aripiprazole and haloperidol compared with placebo.

METHOD: A 4-week, double-blind, randomized study, conducted at 36 U.S. centers between July 1997 and June 1998, compared aripiprazole (15 mg/day, 30 mg/day) to placebo, with haloperidol (10 mg/day) as an active control. Fixed doses of each agent were administered from day 1 throughout the study. A total of 414 patients with a primary DSM-IV diagnosis of schizophrenia or schizoaffective disorder were randomized. Efficacy measures included the Positive and Negative Syndrome Scale (PANSS) total, PANSS positive, PANSS negative, PANSS-derived Brief Psychiatric Rating Scale (BPRS) core, Clinical Global Impressions (CGI)-Severity of Illness, and mean CGI-Improvement scores. Safety and tolerability evaluations included extrapyramidal symptoms (EPS), weight gain, serum prolactin level, and QTc interval.

RESULTS: Both doses of aripiprazole and haloperidol, 10 mg, produced statistically significant (p < or = .05) improvements from baseline in PANSS total, PANSS positive, PANSS-derived BPRS core, and CGI-Severity scores and significantly lower CGI-Improvement scores at endpoint, compared with placebo. Aripiprazole, 15 mg, and haloperidol, 10 mg, significantly improved PANSS negative score compared with placebo. Both aripiprazole doses and haloperidol separated from placebo for PANSS total scores at week 2. Unlike haloperidol, aripiprazole was not associated with significant EPS or prolactin elevation at endpoint compared with placebo. There were no statistically significant differences in mean changes in body weight across the treatment groups versus placebo, and no patients receiving aripiprazole experienced clinically significant increases in QTc interval.

CONCLUSION: Aripiprazole, effective against positive and negative symptoms, is a safe and well-tolerated potential treatment for schizophrenia and schizoaffective disorder.

Efficacy and Safety of Aripiprazole and Haloperidol Versus Placebo in Patients With Schizophrenia and Schizoaffective Disorder

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