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A Study Comparing the Safety and Efficacy of Ziprasidone and Risperidone for the Treatment of Chronic Schizophrenia

Primary Purpose

Schizophrenia

Status
Terminated
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Ziprasidone
Risperidone
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 Schizophrenia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of schizophrenia
  • CGI-S score of 4 or less at baseline

Exclusion Criteria:

  • Concurrent antipsychotic treatment
  • Treatment with antidepressants or mood stabilizers within 2 weeks of randomization
  • Acute exacerbation of schizophrenia within 3 months of baseline

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in Simpson-Angus Scale (SAS) scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24

Secondary Outcome Measures

Change from baseline in cognitive function assessment at Weeks 4 and 24
Change from baseline in Patient Preference Scale (PPS) at Weeks 4, 10, 12, 16, and 24
Changes in Sexual Functioning Questionnaire at Weeks 1, 4, 12, 16, and 24
Change from baseline in Cuestionario Sevilla at Weeks 1, 4, 12, 16, and 24
Change from baseline in Modified Resource Utilization Questionnaire (RUQ) scores at Weeks 3, 4, 6, 10, 12, 16, and 24
Laboratory tests and electrocardiogram at Week 24
Adverse events on Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Clinical Global Impressions-Improvement (CGI-I) scale scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total scores and negative subscale scores at Weeks 4, 10, 12, 16, and 24
Barnes Akathisia Scale (BAS) and Abnormal Involuntary Movements Scale (AIMS) scores at Weeks 4, 10, 12, 16, and 24

Full Information

First Posted
March 20, 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
NCT00645515
Brief Title
A Study Comparing the Safety and Efficacy of Ziprasidone and Risperidone for the Treatment of Chronic Schizophrenia
Official Title
Ziprasidone Versus Risperidone In The Treatment Of Chronic Schizophrenia: A Six Months, Double Blind Randomized, Parallel Group Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated on November 20, 2003 because of poor recruitment. This study was not terminated due to safety/efficacy.
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (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 compare the safety of ziprasidone and risperidone for the treatment of chronic schizophrenia. The primary purpose is to differentiate the effects of ziprasidone and risperidone on extrapyramidal side effects and the secondary purpose is to compare their tolerability and efficacy.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Title
Arm B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ziprasidone
Other Intervention Name(s)
Geodon, Zeldox
Intervention Description
Initial dose of 40 mg capsules twice daily on Days 1-3; dose could be flexibly changed within the range of 40 to 80 mg twice daily for the remainder of the study; treatment duration was 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Description
Initial dose of 10 mg once daily on Days 1-3; dose could be flexibly changed within the range of 3 to 9 mg twice daily for the remainder of the study; treatment duration was 24 weeks.
Primary Outcome Measure Information:
Title
Change from baseline in Simpson-Angus Scale (SAS) scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Time Frame
Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Secondary Outcome Measure Information:
Title
Change from baseline in cognitive function assessment at Weeks 4 and 24
Time Frame
Day 1 and Weeks 4 and 24
Title
Change from baseline in Patient Preference Scale (PPS) at Weeks 4, 10, 12, 16, and 24
Time Frame
Day 1 and Weeks 4, 10, 12, 16, and 24
Title
Changes in Sexual Functioning Questionnaire at Weeks 1, 4, 12, 16, and 24
Time Frame
Day 1 and Weeks 1, 4, 12, 16, and 24
Title
Change from baseline in Cuestionario Sevilla at Weeks 1, 4, 12, 16, and 24
Time Frame
Day 1 and Weeks 1, 4, 12, 16, and 24
Title
Change from baseline in Modified Resource Utilization Questionnaire (RUQ) scores at Weeks 3, 4, 6, 10, 12, 16, and 24
Time Frame
Day 1 and Weeks 3, 4, 6, 10, 12, 16, and 24
Title
Laboratory tests and electrocardiogram at Week 24
Time Frame
Screening and Week 24
Title
Adverse events on Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Time Frame
Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Title
Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Time Frame
Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Title
Clinical Global Impressions-Improvement (CGI-I) scale scores at Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Time Frame
Day 1 and Weeks 1, 2, 3, 4, 6, 10, 12, 16, and 24
Title
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total scores and negative subscale scores at Weeks 4, 10, 12, 16, and 24
Time Frame
Day 1 and Weeks 4, 10, 12, 16, and 24
Title
Barnes Akathisia Scale (BAS) and Abnormal Involuntary Movements Scale (AIMS) scores at Weeks 4, 10, 12, 16, and 24
Time Frame
Day 1 and Weeks 4, 10, 12, 16, and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of schizophrenia CGI-S score of 4 or less at baseline Exclusion Criteria: Concurrent antipsychotic treatment Treatment with antidepressants or mood stabilizers within 2 weeks of randomization Acute exacerbation of schizophrenia within 3 months of baseline
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
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48010
Country
Spain
Facility Name
Pfizer Investigational Site
City
Getxo
State/Province
Vizcaya
ZIP/Postal Code
48990
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281065&StudyName=A%20study%20comparing%20the%20safety%20and%20efficacy%20of%20ziprasidone%20and%20risperidone%20for%20the%20treatment%20of%20chronic%20schizophrenia
Description
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A Study Comparing the Safety and Efficacy of Ziprasidone and Risperidone for the Treatment of Chronic Schizophrenia

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