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A Study of the Effects of Ziprasidone for the Treatment of Schizophrenia or Schizoaffective Disorder in Patients Who Were Switched From Other Antipsychotic Drugs

Primary Purpose

Schizoaffective Disorder, Schizophrenia

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

About this trial

This is an interventional treatment trial for Schizoaffective Disorder

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder
  • Outpatients for at least 3 months on treatment with sulpiride, olanzapine, quetiapine, or risperidone and at least a partial beneficial response to typical antipsychotic treatment including for the current episode
  • Partial improvement in symptoms that justified a switch to ziprasidone

Exclusion Criteria:

  • Diagnosis of major depression or occurrence of moderate depressive symptoms
  • Resistance to conventional antipsychotic drugs
  • Treatment with other drugs such as antiseizure medications, antipsychotics, antidepressants, or mood stabilizing agents that might interfere with the assessement of the efficacy of ziprasidone

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ziprasidone

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in Brief Psychiatric Rating Scale (BPRS) total score

Secondary Outcome Measures

Adverse events
Change from baseline in weight
Change from baseline in prolactin and lipid levels
Change from baseline in electrocardiogram
Change from baseline in Positive and Negative Symptom Scale (PANSS), including PANSS total scores and PANSS positive, PANSS negative, and PANSS general subscale scores
Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores
Clinical Global Impressions-Improvement (CGI-I) scale scores
Change from baseline in movement disorder rating scales, including Barnes Akathisia Scale (BAS) and Abnormal Involuntary Movement Scale (AIMS)
Change from baseline in vital signs
Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) scores

Full Information

First Posted
March 28, 2008
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
NCT00649064
Brief Title
A Study of the Effects of Ziprasidone for the Treatment of Schizophrenia or Schizoaffective Disorder in Patients Who Were Switched From Other Antipsychotic Drugs
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
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (Actual)

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

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to see if differences exist in outcome in patients with schizophrenia or schizoaffective disorder who were switched from other antipsychotics to ziprasidone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizoaffective Disorder, Schizophrenia

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Ziprasidone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ziprasidone
Other Intervention Name(s)
Geodon, Zeldox
Intervention Description
Ziprasidone 40 mg capsules twice daily for the first 7 days followed by flexible dosing between 40 and 80 mg twice daily for the remaining 5 weeks.
Primary Outcome Measure Information:
Title
Change from baseline in Brief Psychiatric Rating Scale (BPRS) total score
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
Weeks 1, 2, and 6
Title
Change from baseline in weight
Time Frame
Baseline and Week 6
Title
Change from baseline in prolactin and lipid levels
Time Frame
Baseline and Week 6
Title
Change from baseline in electrocardiogram
Time Frame
Baseline and Week 6
Title
Change from baseline in Positive and Negative Symptom Scale (PANSS), including PANSS total scores and PANSS positive, PANSS negative, and PANSS general subscale scores
Time Frame
Baseline and Weeks 1, 2, and 6
Title
Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores
Time Frame
Baseline and Weeks 1, 2, and 6
Title
Clinical Global Impressions-Improvement (CGI-I) scale scores
Time Frame
Baseline (using historical data) and Weeks 1, 2, and 6
Title
Change from baseline in movement disorder rating scales, including Barnes Akathisia Scale (BAS) and Abnormal Involuntary Movement Scale (AIMS)
Time Frame
Baseline and Week 6
Title
Change from baseline in vital signs
Time Frame
Baseline and Weeks 1, 2, and 6
Title
Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) scores
Time Frame
Baseline and Week 6

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: Diagnosis of schizophrenia or schizoaffective disorder Outpatients for at least 3 months on treatment with sulpiride, olanzapine, quetiapine, or risperidone and at least a partial beneficial response to typical antipsychotic treatment including for the current episode Partial improvement in symptoms that justified a switch to ziprasidone Exclusion Criteria: Diagnosis of major depression or occurrence of moderate depressive symptoms Resistance to conventional antipsychotic drugs Treatment with other drugs such as antiseizure medications, antipsychotics, antidepressants, or mood stabilizing agents that might interfere with the assessement of the efficacy of ziprasidone
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
Changhua
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Tainan
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281120&StudyName=A%20study%20of%20the%20effects%20of%20ziprasidone%20for%20the%20treatment%20of%20schizophrenia%20or%20schizoaffective%20disorder%20in%20patients%20who%20were%20switched%20fro
Description
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Learn more about this trial

A Study of the Effects of Ziprasidone for the Treatment of Schizophrenia or Schizoaffective Disorder in Patients Who Were Switched From Other Antipsychotic Drugs

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