Effect And Safety Of Ziprasidone Compared To Other Atypical Antipsychotic Drug In Schizophrenic Patients

Phase 3

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder; Psychotic Disorders

• Registration Number: NCT00159770
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

Evaluation of the antipsychotic efficacy and safety of ziprasidone versus olanzapine, risperidone or quetiapine in patients with schizophrenia, schizoaffective and schizophreniform disorders under naturalistic conditions of clinical practice

Detailed Description

Not available

Study Timeline

• Study Start: 2001-11
• Study Completion: 2004-09
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

• Inpatients or outpatients with schizophrenia, schizoaffective and schizophreniform disorders (DSM-IV).
• Patients without adequate current treatment (i.e. intolerance to their current treatment or lack of efficacy of current treatment) based on clinical judgement of the investigator

Exclusion Criteria

• A history of intolerance to ziprasidone, olanzapine, risperidone or quetiapine or any of its ingredients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PANSS (The Positive And Negative Syndrome Scale) in a 12 week period

Secondary Outcome Measures

Name	Time	Method
CGI-C score (Clinical Global Impression of Change), UKU-SERS-Pa (Patient self rating version). Safety and tolerability: ECG, serum cholesterol, triglycerides, prolactin, glucose and body weight

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇭 Solothurn, Switzerland