OBJECTIVE: To compare the effectiveness of amisulpride in acute (up to 8 weeks) and maintenance (week 8 to 12 months) phases of a 12-month course of treatment in a heterogeneous group of patients with schizophrenia. METHODS: We conducted a 12-month, open-label clinical trial with flexible doses of amisulpride among 129 Korean patients with schizophrenia. The Positive and Negative Symptom Scale (PANSS) and several other scales measuring efficacy and tolerability were analyzed during the acute and maintenance phases. RESULTS: The completion rates were 78.3% by week 8 and 55.8% by month 12. Total PANSS scores and scores on the negative-symptom and general-symptom subscales improved significantly during both acute and maintenance periods, but scores on the positive-symptom subscale improved only during the acute phase. Improvement during both treatment phases was significant in all other scales except for the Drug Attitude Inventory. The negative-symptom and mixed-symptom groups showed significant improvement in the PANSS negative subscale, the Clinical Global Impression scale, and the Global Assessment of Functioning during the maintenance period. Hyperprolactinemia and related events were commonly reported. CONCLUSIONS: This study demonstrated the significant effectiveness and a good safety profile of amisulpride for treating acute and 12-month phases of schizophrenia under natural conditions.
OBJECTIVE: To compare the effectiveness of amisulpride in acute (up to 8 weeks) and maintenance (week 8 to 12 months) phases of a 12-month course of treatment in a heterogeneous group of patients with schizophrenia. METHODS: We conducted a 12-month, open-label clinical trial with flexible doses of amisulpride among 129 Korean patients with schizophrenia. The Positive and Negative Symptom Scale (PANSS) and several other scales measuring efficacy and tolerability were analyzed during the acute and maintenance phases. RESULTS: The completion rates were 78.3% by week 8 and 55.8% by month 12. Total PANSS scores and scores on the negative-symptom and general-symptom subscales improved significantly during both acute and maintenance periods, but scores on the positive-symptom subscale improved only during the acute phase. Improvement during both treatment phases was significant in all other scales except for the Drug Attitude Inventory. The negative-symptom and mixed-symptom groups showed significant improvement in the PANSS negative subscale, the Clinical Global Impression scale, and the Global Assessment of Functioning during the maintenance period. Hyperprolactinemia and related events were commonly reported. CONCLUSIONS: This study demonstrated the significant effectiveness and a good safety profile of amisulpride for treating acute and 12-month phases of schizophrenia under natural conditions.