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NCT00137020 Clinical Trial

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

Schizophrenia Clinical Trial

Official title:
A Multi-Center Study to Examine The Clinical Effects of Cross Titration of Antipsychotics With Ziprasidone in Subjects With Schizophrenia or Schizoaffective Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00137020
Other study ID # A1281117
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 2004
Est. completion date April 2006

Study information
Verified date February 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 294
Est. completion date April 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• ziprasidone

Locations
Country Name City State
Egypt Pfizer Investigational Site Alexandria
Egypt Pfizer Investigational Site Assiut
Egypt Pfizer Investigational Site Cairo
Egypt Pfizer Investigational Site Tanta
Greece Pfizer Investigational Site Athens
Greece Pfizer Investigational Site Athens
Greece Pfizer Investigational Site Athens
Greece Pfizer Investigational Site Larissa Mezourlo
Jordan Pfizer Investigational Site Jordan
Kuwait Pfizer Investigational Site Kuwait
Lebanon Pfizer Investigational Site Beirut
Saudi Arabia Pfizer Investigational Site Khobar
South Africa Pfizer Investigational Site Bellair, Durban Kwa-Zulu Natal
South Africa Pfizer Investigational Site Garankuwa Gauteng
South Africa Pfizer Investigational Site Krugersdorp Gauteng
South Africa Pfizer Investigational Site Noordheuwel, Krugersdorp Gauteng
South Africa Pfizer Investigational Site Observatory, Cape Town Western Cape
South Africa Pfizer Investigational Site Pinetown, Durban Kwa-Zulu Natal
Turkey Pfizer Investigational Site Ankara
Turkey Pfizer Investigational Site Bursa
Turkey Pfizer Investigational Site Erzurum
Turkey Pfizer Investigational Site Istanbul
Turkey Pfizer Investigational Site Izmir
Turkey Pfizer Investigational Site Izmir
Turkey Pfizer Investigational Site Manisa
Turkey Pfizer Investigational Site Sisli
United Arab Emirates Pfizer Investigational Site Dubai

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

Egypt,  Greece,  Jordan,  Kuwait,  Lebanon,  Saudi Arabia,  South Africa,  Turkey,  United Arab Emirates, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary efficacy variable will be change from baseline in Brief Psychiatric Rating Scale (BPRS) total score
Secondary Change From Baseline In Clinical Global Impression Severity (CGI-S)
Secondary Clinical Global Impression Improvement (CGI-I)
Secondary Change From Baseline In Positive and Negative Syndrome Scale (PANSS) Total
Secondary Change from baseline in scores on the Montgomery-Asberg Depression Rating Scale (MADRS)
Secondary Change from baseline in scores on the MADRS Without Items 4, 5
Secondary Change from baseline in Global Assessment of Functioning (GAF)
Secondary Change From Baseline In Drug Attitude Inventory (DAI)
Secondary Change From Baseline In Weight
Secondary Change From Baseline In Prolactin And Lipid Levels
Secondary Change From Baseline in Modified Simpson Angus Scale (m-SAS) Total Score
Secondary Change From Baseline in Barnes Akathisia Scale (BAS)
Secondary Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)- Movement Ratings Total Score
Secondary Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)- Global Judgment Of Severity Total Score
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