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Comparative Efficacy and Safety of Ziprasidone and Clozapine in Treatment-Refractory Schizophrenia: Presented at APA

TORONTO, CANADA -- May 26, 2006 -- Ziprasidone and clozapine show equivalent improvement in treatment-resistant/intolerant patients with schizophrenia, according to results of an 18-week, double-blind study.

Results from Monitoring Oral Ziprasidone as Rescue Therapy in Neuroleptic-Resistant/Intolerant Patients (MOZART) were presented here on May 23^rd at the 159^th Annual Meeting of the American Psychiatric Association (APA).

The study involved patients who had failed previous antipsychotic therapy. At least 20% of schizophrenia patients do not respond to antipsychotic treatment, investigators said.

While clozapine is effective for treatment of schizophrenia, it is usually reserved for patients who are unresponsive to previous therapies because of its potential for significant adverse events, said investigator Emilio Sacchetti, MD, chair of psychiatry, Brescia University School of Medicine, and head, department of mental health, Brescia Spedali Civili, Brescia, Italy.

"Effective treatment options that are well tolerated are much needed in this population at every stage of treatment," Dr. Sacchetti said.

Study subjects who were enrolled in the study met criteria for treatment resistance, which was defined as nonresponse in 3 or more adequate antipsychotic trials in the past 5 years or inability to tolerate antipsychotic treatment.

Poor treatment response with prior therapy was cited by the majority of patients enrolled in the study (ziprasidone, 80%; clozapine, 89%). The four most common antipsychotic treatments patients had been receiving at the study screening were haloperidol, olanzapine, risperidone and quetiapine.

Patients were randomized to ziprasidone 80 to 160 mg/day (n=73) or clozapine 250 to 600 mg/day (n=74). The average ziprasidone dose during the study was 130.4 mg/day, and the average clozapine dose was 345.7 mg/day.

Both ziprasidone and clozapine were associated with significant reductions in total score from baseline in the Positive and Negative Syndrome Scale (PANSS) from day 11 through study endpoint. Both drugs were also associated with significant reductions in the Clinical Global Impression - Severity (CGI-S) score from day 11 for ziprasidone and day 18 for clozapine to study endpoint.

Both drugs were also associated with significant improvement from baseline in depressive symptoms (P <.001). Decreases in the Calgary Depression Scale for Schizophrenia were 3.1 for ziprasidone and 2.1 for clozapine.

Ziprasidone, compared to clozapine, were both associated with significant reductions in median cholesterol levels (-5 versus +2 mg/dL), low-density lipoprotein (LDL) cholesterol (-6 vs. +4 mg/dL) and triglycerides (-15 vs. +10 mg/dL), with no change in fasting glucose (0 vs. +6 mg/dL) and body weight (-5.7 vs. +1.8 lbs.).

Dr. Sacchetti said ziprasidone patients reported more insomnia than clozapine patients, while clozapine patients reported more salivation, somnolence and tachycardia.

Overall, ziprasidone offers comparable efficacy but better tolerability than clozapine for patients who have failed prior antipsychotic therapy, he concluded.

The results are consistent with previous studies that support the effectiveness of ziprasidone for schizophrenia patients who have failed previous antipsychotic treatments, he added.

The study was sponsored by Pfizer in Italy.


[Presentation title: Comparative Efficacy and Safety of Ziprasidone and Clozapine in Treatment-Refractory Schizophrenia: Results of a Randomized, Double-Blind, 18-Week Trial. Abstract NR425]

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