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Aripiprazole in the treatment of the psychosis prodrome

An open-label pilot study

Yale University School of Medicine, New Haven, Connecticut, USA

ELIZABETH M. TULLY, MD

University of New Mexico School of Medicine, Albuquerque, New Mexico, USA

BARBARA C. WALSH, PhD, KEITH A. HAWKINS, PsyD, JENNIFER L. CALLAHAN, PhD, SHUKI J. COHEN, PhD, DANIEL H. MATHALON, PhD, MD, TANDY J. MILLER, PhD (deceased) and THOMAS H. McGLASHAN, MD

Yale University School of Medicine, New Haven, Connecticut, USA

Correspondence: Dr Scott Woods, 34 Park Street, New Haven, CT 06519, USA. Email scott.woods{at}yale.edu

Declaration of interest S.W.W. has received grants from Bristol-Myers Squibb, Janssen, and Eli Lilly.

Background Research studies for the treatment of the putative prodromal phase of psychotic disorders have begun to appear.

Aims To obtain preliminary evidence of the short-term efficacy and safety of aripiprazole treatment in people with the psychosis prodrome.

Method Fifteen participants meeting prodrome criteria (mean age 17.1 years, s.d.=5.5) enrolled in an open-label, single-site trial with fixed-flexible dosing of aripiprazole (5–30 mg/day) for 8 weeks.

Results In the mixed-effects repeated-measures analysis, improvement from baseline on the Scale of Prodromal Symptoms total score was statistically significant by the first week. No participant converted to psychosis and 13 completed treatment. Neuropsychological measures showed no consistent improvement; mean weight gain was 1.2 kg. Akathisia emerged in 8 participants, but the mean Barnes Akathisia Scale score fell to baseline levels by the final visit. Adverse events were otherwise minimal.

Conclusions Aripiprazole shows a promising efficacy and safety profile for the psychosis prodrome. Placebo-controlled studies are indicated.

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