Ziprasidone in Treatment-Resistant Schizophrenia: A 52-Week, Open-Label Continuation Study

Objective: To evaluate the efficacy, safety,and tolerability of long-term ziprasidone therapy in treatment-resistant schizophrenia.

Method: This prospective, 1-year, open-label study of ziprasidone (40-160 mg/day) was conducted in subjects who had participated in a previous randomized 12-week comparison of ziprasidone and chlorpromazine in treatment-resistant schizophrenia (DSM-III-R criteria). The clinical response of 62 subjects was evaluated (32 subjects had been on ziprasidone treatment and 30 had been on chlorpromazine treatment prior to enrollment in the continuation study). Assessments included the Positive and Negative Syndrome Scale total and subscale scores, movement disorder scales, body weight, and laboratory measures. This study was conducted from May 2000 to April 2002.

Results: Thirty-three subjects (53%) completed 1 year of open-label ziprasidone therapy. Ziprasidone maintained clinical improvement (no significant symptom exacerbation) in 30 of 41 subjects (73%) who responded to the initial 12-week double-blind treatment with either ziprasidone or chlorpromazine. Ziprasidone did not increase body weight and was associated with a favorable metabolic profile during the continuation study period. There were no significant changes in standard movement disorder measures from the core study baseline during long-term ziprasidone treatment.

Conclusion: Ziprasidone was effective and well tolerated in the long-term therapy of patients with treatment-resistant schizophrenia.