A Study of the Effects of Ziprasidone for the Treatment of Schizophrenia or Schizoaffective Disorder in Patients Who Were Switched From Other Antipsychotic Drugs
A Multi-Center Study To Examine The Clinical Effects Of Cross Titration Of Antipsychotics With Ziprasidone In Subjects With Schizophrenia Or Schizoaffective Disorder
1 other identifier
interventional
46
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2003
Shorter than P25 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 28, 2008
CompletedFirst Posted
Study publicly available on registry
April 1, 2008
CompletedFebruary 21, 2021
February 1, 2021
March 28, 2008
February 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in Brief Psychiatric Rating Scale (BPRS) total score
Week 6
Secondary Outcomes (10)
Adverse events
Weeks 1, 2, and 6
Change from baseline in weight
Baseline and Week 6
Change from baseline in prolactin and lipid levels
Baseline and Week 6
Change from baseline in electrocardiogram
Baseline and Week 6
Change from baseline in Positive and Negative Symptom Scale (PANSS), including PANSS total scores and PANSS positive, PANSS negative, and PANSS general subscale scores
Baseline and Weeks 1, 2, and 6
- +5 more secondary outcomes
Study Arms (1)
Ziprasidone
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Pfizer Investigational Site
Changhua, Taiwan
Pfizer Investigational Site
Tainan, Taiwan
Pfizer Investigational Site
Taipei, Taiwan
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 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2008
First Posted
April 1, 2008
Study Start
December 1, 2003
Study Completion
September 1, 2004
Last Updated
February 21, 2021
Record last verified: 2021-02