A Study of the Effects of Ziprasidone for the Treatment of Schizophrenia or Schizoaffective Disorder in Patients Who Were Switched From Other Antipsychotic Drugs

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-Center Study To Examine The Clinical Effects Of Cross Titration Of Antipsychotics With Ziprasidone In Subjects With Schizophrenia Or Schizoaffective Disorder

Conditions
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Schizoaffective Disorder, Schizophrenia

Intervention / Treatment
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* Drug: Ziprasidone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ziprasidone<br> | Drug: Ziprasidone<br>* 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.<br>* Other names: Geodon, Zeldox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Brief Psychiatric Rating Scale (BPRS) total score |  | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores |  | Baseline and Weeks 1, 2, and 6 | 
| Clinical Global Impressions-Improvement (CGI-I) scale scores |  | Baseline (using historical data) and Weeks 1, 2, and 6 | 
| Change from baseline in movement disorder rating scales, including Barnes Akathisia Scale (BAS) and Abnormal Involuntary Movement Scale (AIMS) |  | Baseline and Week 6 | 
| Change from baseline in vital signs |  | Baseline and Weeks 1, 2, and 6 | 
| Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) scores |  | Baseline and Week 6 |