A Study of the Effects of Ziprasidone for the Treatment of Schizophrenia or Schizoaffective Disorder in Patients Who Were Switched From Other Antipsychotic Drugs

Phase 4

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder
• Interventions: Drug: Ziprasidone

• Registration Number: NCT00649064
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

The purpose of this study is to see if differences exist in outcome in patients with schizophrenia or schizoaffective disorder who were switched from other antipsychotics to ziprasidone.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study Completion: 2004-09
• Study First Submitted: 2008-03-28
• Study First Submitted QC: 2008-03-28
• Study First Posted: 2008-04-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Diagnosis of schizophrenia or schizoaffective disorder
• Outpatients for at least 3 months on treatment with sulpiride, olanzapine, quetiapine, or risperidone and at least a partial beneficial response to typical antipsychotic treatment including for the current episode
• Partial improvement in symptoms that justified a switch to ziprasidone

Exclusion Criteria

• Diagnosis of major depression or occurrence of moderate depressive symptoms
• Resistance to conventional antipsychotic drugs
• Treatment with other drugs such as antiseizure medications, antipsychotics, antidepressants, or mood stabilizing agents that might interfere with the assessement of the efficacy of ziprasidone

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ziprasidone	Ziprasidone	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in Brief Psychiatric Rating Scale (BPRS) total score	Week 6

Secondary Outcome Measures

Name	Time	Method
Change from baseline in weight	Baseline and Week 6
Change from baseline in prolactin and lipid levels	Baseline and Week 6
Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores	Baseline and Weeks 1, 2, and 6
Adverse events	Weeks 1, 2, and 6
Change from baseline in electrocardiogram	Baseline and Week 6
Clinical Global Impressions-Improvement (CGI-I) scale scores	Baseline (using historical data) and Weeks 1, 2, and 6
Change from baseline in movement disorder rating scales, including Barnes Akathisia Scale (BAS) and Abnormal Involuntary Movement Scale (AIMS)	Baseline and Week 6
Change from baseline in vital signs	Baseline and Weeks 1, 2, and 6
Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) scores	Baseline and Week 6
Change from baseline in Positive and Negative Symptom Scale (PANSS), including PANSS total scores and PANSS positive, PANSS negative, and PANSS general subscale scores	Baseline and Weeks 1, 2, and 6

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇳 Taipei, Taiwan