Back to resultsA Study of the Efficacy and Safety of Ziprasidone for the Treatment of Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
Primary Purpose
Schizophrenia, Schizoaffective Disorder
Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Ziprasidone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of schizophrenia or schizoaffective disorder.
- Inpatients with acute exacerbation of psychotic symptoms.
- Patients with a minimum score of 40 on the BPRS scale (1-7).
Exclusion Criteria:
- Concurrent treatment with antipsychotic agents at study drug initiation (within 12 hours prior to study drug initiation); for depot agents a period of two weeks or one cycle, whichever is the longer, must occur between last administration and study drug initiation.
- Treatment with antidepressants or mood stabilizers within 7 days of start of ziprasidone.
- Patients currently receiving clozapine.
- Patients at immediate risk of committing harm to self or others.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- 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 to endpoint in Brief Psychiatric Rating Scale (BPRS) total score
Secondary Outcome Measures
Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale score
Change from baseline to endpoint in Clinical Global Impressions-Improvement (CGI-I) scale score
Simpson-Angus Scale (SAS)
Barnes Akathisia Scale (BAS)
Laboratory tests
Electrocardiogram
Adverse events
Abnormal Involuntary Movement Scale (AIMS)
Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total score
Change from baseline to endpoint in Covi Anxiety Scale score
Change from baseline to endpoint in Positive PANSS subscale score
Change from baseline to endpoint in Negative PANSS subscale score
Full Information
NCT ID
NCT00650429
First Posted
March 28, 2008
Last Updated
February 18, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00650429
Brief Title
A Study of the Efficacy and Safety of Ziprasidone for the Treatment of Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
Official Title
Ziprasidone Intramuscular/Oral In The Treatment Of Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder: A Six-Week Open Administration Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 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
This study was conducted to examine the efficacy and tolerability of ziprasidone intramuscular (IM), and to assess the effect of switching from IM to oral ziprasidone for the treatment of acute exacerbation of schizophrenia and schizoaffective disorder in a Latin American population.
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 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (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
IM ziprasidone at an initial dose of 10 or 20 mg for the first 3 days; additional doses could be administered according to clinical need, with the maximum total daily IM dose of 40 mg. On Day 4, IM treatment was switched to oral (PO) treatment at an initial dose of 40 mg twice daily for the first 2 days; doses could be subsequently adjusted within the range of 40 to 80 mg twice daily. Total treatment duration was 6 weeks.
Primary Outcome Measure Information:
Title
Change from baseline to endpoint in Brief Psychiatric Rating Scale (BPRS) total score
Time Frame
Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Secondary Outcome Measure Information:
Title
Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale score
Time Frame
Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Title
Change from baseline to endpoint in Clinical Global Impressions-Improvement (CGI-I) scale score
Time Frame
Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Title
Simpson-Angus Scale (SAS)
Time Frame
Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO)
Title
Barnes Akathisia Scale (BAS)
Time Frame
Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO)
Title
Laboratory tests
Time Frame
Screening and Week 6
Title
Electrocardiogram
Time Frame
Screening and Week 6
Title
Adverse events
Time Frame
Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Title
Abnormal Involuntary Movement Scale (AIMS)
Time Frame
Day 1 (IM), Day 4 (Switch), and Week 6 (PO)
Title
Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total score
Time Frame
Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Title
Change from baseline to endpoint in Covi Anxiety Scale score
Time Frame
Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Title
Change from baseline to endpoint in Positive PANSS subscale score
Time Frame
Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Title
Change from baseline to endpoint in Negative PANSS subscale score
Time Frame
Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
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 or schizoaffective disorder.
Inpatients with acute exacerbation of psychotic symptoms.
Patients with a minimum score of 40 on the BPRS scale (1-7).
Exclusion Criteria:
Concurrent treatment with antipsychotic agents at study drug initiation (within 12 hours prior to study drug initiation); for depot agents a period of two weeks or one cycle, whichever is the longer, must occur between last administration and study drug initiation.
Treatment with antidepressants or mood stabilizers within 7 days of start of ziprasidone.
Patients currently receiving clozapine.
Patients at immediate risk of committing harm to self or others.
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
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64800
Country
Mexico
Facility Name
Pfizer Investigational Site
City
DF
ZIP/Postal Code
14420
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Mexico City
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Mexico D F
ZIP/Postal Code
14269
Country
Mexico
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281056&StudyName=A%20study%20of%20the%20efficacy%20and%20safety%20of%20ziprasidone%20for%20the%20treatment%20of%20acute%20exacerbation%20of%20schizophrenia%20or%20schizoaffective%20disorder
Description
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Learn more about this trial
A Study of the Efficacy and Safety of Ziprasidone for the Treatment of Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
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