A Study to Compare the Efficacy and Safety of Ziprasidone and Risperidone for the Treatment of Schizophrenia in Chinese Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-05-31

Brief Summary

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The purpose of this study is to compare the efficacy and safety of ziprasidone and risperidone for the treatment of schizophrenia in Chinese patients

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The Primary Evaluation is the Change From Baseline at End of Study for CDSS Total Scores. The Secondary Efficacy Evaluations Include: MADRS, PANSS Total Scores and Subscales and Responder Rate; CGI-S and CGI-I Scales. Safety Evaluations Include: Laboratory Test Abnormalities; BARS and SAS; Physical Examinations; Vital Signs; Electrocardiogram,Etc. +1 more

UNKNOWN

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type ACTIVE_COMPARATOR

Risperidone

Intervention Type DRUG

Oral risperidone capsules 1 and 2 mg; doses were 1 mg once daily on Days 1-2, 2 mg once daily on Days 3-4, 3 mg once daily on Days 5-7, and 1, 2, or 3 mg twice daily during Weeks 2-6

B

Group Type EXPERIMENTAL

Ziprasidone

Intervention Type DRUG

Oral ziprasidone capsules 40, 60, and 80 mg; doses were 40 mg twice daily on Days 1-2, 60 mg twice daily on Days 3-7, and 40, 60, or 80 mg twice daily during Weeks 2-6

Interventions

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Risperidone

Oral risperidone capsules 1 and 2 mg; doses were 1 mg once daily on Days 1-2, 2 mg once daily on Days 3-4, 3 mg once daily on Days 5-7, and 1, 2, or 3 mg twice daily during Weeks 2-6

Intervention Type DRUG

Ziprasidone

Oral ziprasidone capsules 40, 60, and 80 mg; doses were 40 mg twice daily on Days 1-2, 60 mg twice daily on Days 3-7, and 40, 60, or 80 mg twice daily during Weeks 2-6

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Hospitalized patients with schizophrenia
* Miminum PANSS score of 60 when randomized

Exclusion Criteria

* Planned, regular use of antipsyhotics within 1 week of randomization
* Previous treatment with risperidone that resulted in intolerance or lack of response to risperidone

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No