A Study Comparing the Safety and Efficacy of Ziprasidone and Risperidone for the Treatment of Chronic Schizophrenia

Viatris

Status and phase: Terminated; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Risperidone; Drug: Ziprasidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00645515

A1281065

Details and patient eligibility

About

The purpose of this study is to compare the safety of ziprasidone and risperidone for the treatment of chronic schizophrenia. The primary purpose is to differentiate the effects of ziprasidone and risperidone on extrapyramidal side effects and the secondary purpose is to compare their tolerability and efficacy.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of schizophrenia
• CGI-S score of 4 or less at baseline

Exclusion criteria

• Concurrent antipsychotic treatment
• Treatment with antidepressants or mood stabilizers within 2 weeks of randomization
• Acute exacerbation of schizophrenia within 3 months of baseline

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups

Arm A

Experimental group

Treatment:

Drug: Ziprasidone

Arm B

Active Comparator group

Treatment:

Drug: Risperidone