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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00137020
First received: August 26, 2005
Last updated: August 11, 2006
Last verified: August 2006
  Purpose

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


Condition Intervention Phase
Schizophrenia
Psychotic Disorders
Drug: ziprasidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Secondary Outcome Measures:
  • Change From Baseline In Clinical Global Impression Severity (CGI-S)
  • Clinical Global Impression Improvement (CGI-I)
  • 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

Estimated Enrollment: 294
Study Start Date: November 2004
Estimated Study Completion Date: April 2006
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137020

Locations
Egypt
Pfizer Investigational Site
Alexandria, Egypt
Pfizer Investigational Site
Assiut, Egypt
Pfizer Investigational Site
Cairo, Egypt
Pfizer Investigational Site
Tanta, Egypt
Greece
Pfizer Investigational Site
Larissa, Mezourlo, Greece, 41110
Pfizer Investigational Site
Athens, Greece, 11528
Pfizer Investigational Site
Athens, Greece, 15126
Pfizer Investigational Site
Athens, Greece, 12462
Jordan
Pfizer Investigational Site
Jordan, Jordan
Kuwait
Pfizer Investigational Site
Kuwait, Kuwait, 13041
Lebanon
Pfizer Investigational Site
Beirut, Lebanon
Saudi Arabia
Pfizer Investigational Site
Khobar, Saudi Arabia, 31451
South Africa
Pfizer Investigational Site
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
Bellair, Durban, Kwa-Zulu Natal, South Africa, 4094
Pfizer Investigational Site
Pinetown, Durban, Kwa-Zulu Natal, South Africa, 3600
Pfizer Investigational Site
Observatory, Cape Town, Western Cape, South Africa, 7925
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, 35340
Pfizer Investigational Site
Izmir, Turkey
Pfizer Investigational Site
Manisa, Turkey
Pfizer Investigational Site
Sisli, Turkey
United Arab Emirates
Pfizer Investigational Site
Dubai, United Arab Emirates
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00137020     History of Changes
Other Study ID Numbers: A1281117
Study First Received: August 26, 2005
Last Updated: August 11, 2006
Health Authority: Turkey: Ministry of Health

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Ziprasidone
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 24, 2014