Clinical Effect Of Cross Titration Of Antipsychotics With Ziprasidone In Schizophrenia Or Schizoaffective Disorder

Phase 4

Completed

• Conditions: Schizophrenia; Psychotic Disorders

• Registration Number: NCT00137020
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

The primary objective is to compare effectiveness of ziprasidone treatment to current treatments (haloperidol, olanzapine or risperidone) measured by change in Brief Psychiatric Rating Scale (BPRS) scores versus baseline

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-08-26
• Study First Submitted QC: 2005-08-26
• Study First Posted: 2005-08-29
• Study Completion: 2006-04
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

Inclusion Criteria

• Primary diagnosis of schizophrenia or schizoaffective disorder, using DSM-IV criteria.
• Currently receiving either haloperidol, olanzapine or risperidone within -/+ 25% of the recommended daily dose (as delineated by the medication's package insert

Exclusion Criteria

• Resistance to conventional antipsychotic drugs
• With antipsychotic agents other than olanzapine, risperidone or haloperidol at start of treatment regimen within 12 hours prior to first dose of study drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The primary efficacy variable will be change from baseline in Brief Psychiatric Rating Scale (BPRS) total score

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression Improvement (CGI-I)
Change from baseline in scores on the Montgomery-Asberg Depression Rating Scale (MADRS)
Change from baseline in scores on the MADRS Without Items 4, 5
Change from baseline in Global Assessment of Functioning (GAF)
Change From Baseline In Drug Attitude Inventory (DAI)
Change From Baseline in Modified Simpson Angus Scale (m-SAS) Total Score
Change From Baseline in Barnes Akathisia Scale (BAS)
Change From Baseline In Clinical Global Impression Severity (CGI-S)
Change From Baseline In Positive and Negative Syndrome Scale (PANSS) Total
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)- Movement Ratings Total Score
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)- Global Judgment Of Severity Total Score
Change From Baseline In Prolactin And Lipid Levels
Change From Baseline In Weight

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇦🇪 Dubai, United Arab Emirates