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A Study of the Efficacy and Safety of Ziprasidone in Patients With Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
Efficacy And Safety Of Ziprasidone In Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder, Including Patients With A Diagnosis Of Recent Onset
1 other identifier
interventional
1
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 schizophrenia
Started Sep 2004
Shorter than P25 for phase_3 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 25, 2008
CompletedFirst Posted
Study publicly available on registry
March 27, 2008
CompletedFebruary 21, 2021
February 1, 2021
March 25, 2008
February 18, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 24
Week 24
Change from baseline in PANSS (Depression-C) score at Week 24
Week 24
Change from baseline in Clinical Global Impressions-Severity (CGI-S) total score at Week 24
Week 24
Change from baseline in CGI-S total score at Week 24
Week 24
Secondary Outcomes (8)
Vital signs and weight at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
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
Week 24
Adverse events on Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
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
Week 24
Laboratory parameters at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
- +3 more secondary outcomes
Study Arms (1)
Arm A
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pfizer Investigational Site
Lisbon, 1600-219, Portugal
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2008
First Posted
March 27, 2008
Study Start
September 1, 2004
Study Completion
March 1, 2005
Last Updated
February 21, 2021
Record last verified: 2021-02