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

Primary Purpose

Schizophrenia, Psychotic Disorders

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
ziprasidone
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

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

Full Information

First Posted
August 26, 2005
Last Updated
February 18, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00137020
Brief Title
Clinical Effect Of Cross Titration Of Antipsychotics With Ziprasidone In Schizophrenia Or Schizoaffective Disorder
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 Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Psychotic Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
294 (false)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Alexandria
Country
Egypt
Facility Name
Pfizer Investigational Site
City
Assiut
Country
Egypt
Facility Name
Pfizer Investigational Site
City
Cairo
Country
Egypt
Facility Name
Pfizer Investigational Site
City
Tanta
Country
Egypt
Facility Name
Pfizer Investigational Site
City
Larissa
State/Province
Mezourlo
ZIP/Postal Code
41110
Country
Greece
Facility Name
Pfizer Investigational Site
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Pfizer Investigational Site
City
Athens
ZIP/Postal Code
12462
Country
Greece
Facility Name
Pfizer Investigational Site
City
Athens
ZIP/Postal Code
15126
Country
Greece
Facility Name
Pfizer Investigational Site
City
Jordan
Country
Jordan
Facility Name
Pfizer Investigational Site
City
Kuwait
ZIP/Postal Code
13041
Country
Kuwait
Facility Name
Pfizer Investigational Site
City
Beirut
Country
Lebanon
Facility Name
Pfizer Investigational Site
City
Khobar
ZIP/Postal Code
31451
Country
Saudi Arabia
Facility Name
Pfizer Investigational Site
City
Garankuwa
State/Province
Gauteng
ZIP/Postal Code
0208
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Krugersdorp
State/Province
Gauteng
ZIP/Postal Code
1739
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Noordheuwel, Krugersdorp
State/Province
Gauteng
ZIP/Postal Code
1739
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Bellair, Durban
State/Province
Kwa-Zulu Natal
ZIP/Postal Code
4094
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Pinetown, Durban
State/Province
Kwa-Zulu Natal
ZIP/Postal Code
3600
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Observatory, Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Ankara
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Bursa
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Erzurum
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Istanbul
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Izmir
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Manisa
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Sisli
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Dubai
Country
United Arab Emirates

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281117&StudyName=Clinical+Effect+Of+Cross+Titration+Of+Antipsychotics+With+Ziprasidone+In+Schizophrenia+Or+Schizioaffective+Disorder
Description
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Clinical Effect Of Cross Titration Of Antipsychotics With Ziprasidone In Schizophrenia Or Schizoaffective Disorder

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