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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00137020
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : August 15, 2006
Information provided by:

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

Condition or disease Intervention/treatment Phase
Schizophrenia Psychotic Disorders Drug: ziprasidone Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 294 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2004
Study Completion Date : April 2006

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

Secondary Outcome Measures :
  1. Change From Baseline In Clinical Global Impression Severity (CGI-S)
  2. Clinical Global Impression Improvement (CGI-I)
  3. Change From Baseline In Positive and Negative Syndrome Scale (PANSS) Total
  4. Change from baseline in scores on the Montgomery-Asberg Depression Rating Scale (MADRS)
  5. Change from baseline in scores on the MADRS Without Items 4, 5
  6. Change from baseline in Global Assessment of Functioning (GAF)
  7. Change From Baseline In Drug Attitude Inventory (DAI)
  8. Change From Baseline In Weight
  9. Change From Baseline In Prolactin And Lipid Levels
  10. Change From Baseline in Modified Simpson Angus Scale (m-SAS) Total Score
  11. Change From Baseline in Barnes Akathisia Scale (BAS)
  12. Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)- Movement Ratings Total Score
  13. Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)- Global Judgment Of Severity Total Score

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00137020

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Pfizer Investigational Site
Alexandria, Egypt
Pfizer Investigational Site
Assiut, Egypt
Pfizer Investigational Site
Cairo, Egypt
Pfizer Investigational Site
Tanta, Egypt
Pfizer Investigational Site
Larissa, Mezourlo, Greece, 41110
Pfizer Investigational Site
Athens, Greece, 11528
Pfizer Investigational Site
Athens, Greece, 12462
Pfizer Investigational Site
Athens, Greece, 15126
Pfizer Investigational Site
Jordan, Jordan
Pfizer Investigational Site
Kuwait, Kuwait, 13041
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
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
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Study Director: Pfizer Call Center Pfizer
Additional Information:
Layout table for additonal information Identifier: NCT00137020    
Other Study ID Numbers: A1281117
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: August 15, 2006
Last Verified: August 2006
Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents