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A Study of the Efficacy and Safety of Ziprasidone in Patients With Acute Exacerbation of Schizophrenia or Schizoaffective Disorder

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Terminated
Phase
Phase 3
Locations
Portugal
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 Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients not currently being treated with antipsychotic medication and neuroleptic naive patients
  • Diagnosis of schizophrenia or schizoaffective disorder
  • Antipsychotic treatment prior to screening was to be for a cumulative period of less than 5 years

Exclusion Criteria:

  • Patients at immediate risk of committing harm to self or others
  • Treatment with clozapine within 3 months prior to baseline
  • History of neuroleptic treatment
  • Current antipsychotic treatment

Sites / Locations

  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm A

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 24
Change from baseline in PANSS (Depression-C) score at Week 24
Change from baseline in Clinical Global Impressions-Severity (CGI-S) total score at Week 24
Change from baseline in CGI-S total score at Week 24

Secondary Outcome Measures

Vital signs and weight at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
Change from baseline in Clinical Global Impressions-Improvement (CGI-I) score at Week 24
Adverse events on Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
Change from baseline in Global Assessment of Functioning (GAF) score at Week 24
Laboratory parameters at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
Simpson-Angus Scale (SAS) at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
Barnes Akathisia Scale (BAS) at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
Electrocardiogram

Full Information

First Posted
March 25, 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
NCT00645229
Brief Title
A Study of the Efficacy and Safety of Ziprasidone in Patients With Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
Official Title
Efficacy And Safety Of Ziprasidone In Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder, Including Patients With A Diagnosis Of Recent Onset
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Please see Detailed Description for termination reason.
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (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 evaluate the efficacy and safety of ziprasidone in acute exacerbation of schizophrenia or schizoaffective disorder, including patients with recent onset of symptoms
Detailed Description
The study was prematurely discontinued due to the difficulty of subject recruitment on March 24, 2005. There were no safety concerns that led to the decision to terminate.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ziprasidone
Other Intervention Name(s)
Geodon, Zeldox
Intervention Description
Ziprasidone 20 mg capsules twice daily on Days 1-3; dose could be increased if clinically indicated up to 80 mg twice daily; total treatment duration was to be 24 weeks
Primary Outcome Measure Information:
Title
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 24
Time Frame
Week 24
Title
Change from baseline in PANSS (Depression-C) score at Week 24
Time Frame
Week 24
Title
Change from baseline in Clinical Global Impressions-Severity (CGI-S) total score at Week 24
Time Frame
Week 24
Title
Change from baseline in CGI-S total score at Week 24
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Vital signs and weight at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
Time Frame
Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
Title
Change from baseline in Clinical Global Impressions-Improvement (CGI-I) score at Week 24
Time Frame
Week 24
Title
Adverse events on Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
Time Frame
Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
Title
Change from baseline in Global Assessment of Functioning (GAF) score at Week 24
Time Frame
Week 24
Title
Laboratory parameters at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
Time Frame
Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
Title
Simpson-Angus Scale (SAS) at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
Time Frame
Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
Title
Barnes Akathisia Scale (BAS) at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
Time Frame
Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
Title
Electrocardiogram
Time Frame
Screening and Month 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients not currently being treated with antipsychotic medication and neuroleptic naive patients Diagnosis of schizophrenia or schizoaffective disorder Antipsychotic treatment prior to screening was to be for a cumulative period of less than 5 years Exclusion Criteria: Patients at immediate risk of committing harm to self or others Treatment with clozapine within 3 months prior to baseline History of neuroleptic treatment Current antipsychotic treatment
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
Lisboa
ZIP/Postal Code
1600-219
Country
Portugal

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281055&StudyName=A%20study%20of%20the%20efficacy%20and%20safety%20of%20ziprasidone%20in%20patients%20with%20acute%20exacerbation%20of%20schizophrenia%20or%20schizoaffective%20disorder
Description
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A Study of the Efficacy and Safety of Ziprasidone in Patients With Acute Exacerbation of Schizophrenia or Schizoaffective Disorder

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