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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy And Safety Of Ziprasidone In Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder, Including Patients With A Diagnosis Of Recent Onset

Conditions
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Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Drug: Ziprasidone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Arm A<br> | Drug: Ziprasidone<br>* 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<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 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Simpson-Angus Scale (SAS) 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 | 
| Barnes Akathisia Scale (BAS) 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 | 
| Electrocardiogram |  | Screening and Month 4 |