Efficacy and tolerability of aripiprazole in first-episode drug-naive patients with schizophrenia: an open-label trial.

OBJECTIVE

The purpose of this study is to investigate the safety and efficacy of aripiprazole in first-episode drug-naive patients with schizophrenia.

METHODS

A total of 45 patients were enrolled in an open-label 12-week study. Dosing was determined by clinical judgment. The main efficacy measure was the Brief Psychiatric Rating Scale (BPRS). Patients with a 50% or greater decrease in BPRS total score plus a final Clinical Global Impressions-Severity of Illness scale score of < or =3 (mildly ill) were considered as responders.

RESULTS

Of 45 subjects, 3 did not return after baseline assessment, leaving an intent-to-treat sample of 42 subjects. The mean dosage of aripiprazole was 17.8 mg/d (SD, 9.5) at study end point (last observation). The responder rate was 78.6% (33/42). The BPRS excitement symptom subscale score at baseline was significantly higher in nonresponders compared with responders (P < 0.001). Restlessness/irritability was the most frequent side effect (40.5% [17/42]), being well controlled by benzodiazepines. Body weight and metabolic parameters such as cholesterol, triglycerides, and fasting glucose did not change during this study.

CONCLUSIONS

Aripiprazole produced favorable outcomes and good tolerance in the first-episode schizophrenia. Double-blind crossover trials are needed to confirm our observation.