Objective:

We investigated the long-term efficacy, safety, and tolerability of aripiprazole in a large number of patients with schizophrenia, schizophreniform disorder, and schizoaffective disorder in Korea.

Methods:

This was an open-label, multi-center, single-arm, 52-week study of patients with schizophrenia, schizophreniform disorder, and schizoaffective disorder. Korean patients (N=300) experiencing either a first episode or recurrence participated in this study. The primary efficacy measure was the Positive and Negative Syndrome Scale (PANSS) total score. Secondary efficacy measure was the positive and negative subscales, and the Clinical Global Impression-Severity of Illness (CGI-S). Safety was evaluated prospectively by recording treatment-emergent adverse events; measuring extrapyramidal symptoms (EPS), vital signs, and body weight; and performing laboratory test.

Results:

Overall, 55 (18.33%) of the patients completed the entire 52-week study. Treatment with aripiprazole provided rapid and significant improvement in all of the efficacy measures. Comparing PANSS total scores, PANSS positive subscale scores, and CGI-S scores, first-episode patients showed significant improvement than the patients who had experienced at least one recurrence. There were no significant differences in the mean change of EPS during the study, except for akathisia at week 8 and a significant decrease in serum prolactin level in patients experiencing first and recurrent episodes. At the end of the study, the mean weight gain was 2.40 kg.

Conclusion:

Aripiprazole is effective and safe for patients with schizophrenia, schizophreniform disorder, and schizoaffective disorder during a long-term, 52-week treatment. The result may be associated with the unique mechanism of aripiprazole. We have extended the findings of previous studies in the United States and other countries and demonstrated similar effectiveness of aripiprazole for Korean patients.