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

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

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

Study Overview

• Status: Completed
• Conditions: Psychotic Disorders; Schizophrenia
• Intervention / Treatment: Drug: ziprasidone

• Study Type: Interventional
• Enrollment: 294
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Pfizer Investigational Site
  • Assiut, Egypt
    • Pfizer Investigational Site
  • Cairo, Egypt
    • Pfizer Investigational Site
  • Tanta, Egypt
    • Pfizer Investigational Site
• Greece
  • Athens, Greece, 12462
    • Pfizer Investigational Site
  • Athens, Greece, 11528
    • Pfizer Investigational Site
  • Athens, Greece, 15126
    • Pfizer Investigational Site
  • Mezourlo
    • Larissa, Mezourlo, Greece, 41110
      • Pfizer Investigational Site
• Jordan
  • Jordan, Jordan
    • Pfizer Investigational Site
• Kuwait
  • Kuwait, Kuwait, 13041
    • Pfizer Investigational Site
• Lebanon
  • Beirut, Lebanon
    • Pfizer Investigational Site
• Saudi Arabia
  • Khobar, Saudi Arabia, 31451
    • Pfizer Investigational Site
• South Africa
  • Gauteng
    • Garankuwa, Gauteng, South Africa, 0208
      • Pfizer Investigational Site
    • Krugersdorp, Gauteng, South Africa, 1739
      • Pfizer Investigational Site
    • Noordheuwel, Krugersdorp, Gauteng, South Africa, 1739
      • Pfizer Investigational Site
  • Kwa-Zulu Natal
    • Bellair, Durban, Kwa-Zulu Natal, South Africa, 4094
      • Pfizer Investigational Site
    • Pinetown, Durban, Kwa-Zulu Natal, South Africa, 3600
      • Pfizer Investigational Site
  • Western Cape
    • Observatory, Cape Town, Western Cape, South Africa, 7925
      • Pfizer Investigational Site
• Turkey
  • Ankara, Turkey
    • Pfizer Investigational Site
  • Bursa, Turkey
    • Pfizer Investigational Site
  • Erzurum, Turkey
    • Pfizer Investigational Site
  • Istanbul, Turkey
    • Pfizer Investigational Site
  • Izmir, Turkey, 35340
    • Pfizer Investigational Site
  • Izmir, Turkey
    • Pfizer Investigational Site
  • Manisa, Turkey
    • Pfizer Investigational Site
  • Sisli, Turkey
    • Pfizer Investigational Site
• United Arab Emirates
  • Dubai, United Arab Emirates
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary efficacy variable will be change from baseline in Brief Psychiatric Rating Scale (BPRS) total score

Secondary Outcome Measures

Outcome Measure
Clinical Global Impression Improvement (CGI-I)
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 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 Weight
Change From Baseline In Prolactin And Lipid Levels
Change From Baseline in Modified Simpson Angus Scale (m-SAS) Total Score
Change From Baseline in Barnes Akathisia Scale (BAS)
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

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Study Completion: April 1, 2006

Study Registration Dates

• First Submitted: August 26, 2005
• First Submitted That Met QC Criteria: August 26, 2005
• First Posted (Estimate): August 29, 2005

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Ziprasidone
• Other Study ID Numbers: A1281117