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OpenTrials
Completed

NCT Number: NCT00137020

Clinical Effect Of Cross Titration Of Antipsychotics With Ziprasidone In 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

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Alexandria, Egypt

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ziprasidone

Drug

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2006
First posted
Aug 29, 2005
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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