A Study Comparing the Efficacy and Safety of Ziprasidone and Aripiprazole for the Treatment fo Schizophrenia or Schizoaffective Disorder in Hospitalized Patients

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy and safety of ziprasidone and aripiprazole in hospitalized patients with schizophrenia or schizoaffective disorder

Official Title
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A Four-Week Double Blind Multicenter Study Comparing The Efficacy And Safety Of Ziprasidone To Aripiprazole In Subjects With Schizophrenia Or Schizoaffective Disorder Needing Inpatient Care

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Aripiprazole
* Drug: Ziprasidone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized patients with schizophrenia or schizoaffective disorder At least a 6th grade reading level Males or females, between 18 and 70 years of age at the time of consent Subjects must have been hospitalized for no more than 14 consecutive days immediately prior to screening Exclusion Criteria: Psychiatric disorder other than schizophrenia or schizoaffective disorder History of arrhythmia, heart attack, or heart failure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aripiprazole<br> | Drug: Aripiprazole<br>* Oral aripiprazole capsules 15 mg once daily from Days 1-14; thereafter, doses could be adjusted on Days 14 and 21 to 10, 15, or 30 mg once daily; patients treated for 28 days<br>|
| Active Comparator: Ziprasidone<br> | Drug: Ziprasidone<br>* Oral ziprasidone capsules 40 mg twice daily on Day 1, 60 mg twice daily on Day 2, 80 mg twice daily on Days 3-14; thereafter, doses could be adjusted on Days 14 and 21 to 40, 60, or 80 mg twice daily; patients treated for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale scores. |  | 28 days | 
| Change from baseline to endpoint in Brief Psychiatric Rating Scale derived (BPRSd) total scores. |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Positive and Negative Syndrome Scale (PANSS) positive subscale scores. |  | 28 days | 
| Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS negative subscale scores. |  | 28 days | 
| Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS Depression factor scores. |  | 28 days | 
| Change from baseline to endpoint in Calgary Depression Scale for Schizophrenia (CDSS) scores. |  | 28 days | 
| Change from baseline to Days 2, 4, 7, 14, 21, and 28 in COVI Anxiety Scale scores. |  | 28 days | 
| Change from baseline to endpoint in Global Assessment of Functioning (GAF) scale scores. |  | 28 days | 
| Change from baseline to endpoint in Drug Attitude Inventory (DAI) scores. |  | 28 days | 
| Change from baseline to endpoint in Personal Evaluation of Transition in Treatment (PETiT) scale scores. |  | 28 days | 
| Change from baseline to endpoint in Patient Preference Scale (PPS) scores. |  | 28 days | 
| Change from baseline to endpoint in Life Skills Profile (LSP). |  | 28 days | 
| Change from baseline in Outcome Resource Discharge Questionnaire (ORDQ) scores on Days 2, 4, 7, 14, 21, and 28. |  | 28 days | 
| Change from baseline to endpoint in Cognitive Battery. |  | 28 days | 
| Change from baseline to Days 2, 4, 7, 14, 21, and 28 in PANSS total scores. |  | 28 days | 
| Change from baseline to Days 2, 4, 7, 14, 21, and 28 in Clinical Global Impressions-Improvement (CGI-I) scale scores. |  | 28 days | 
| Adverse events, laboratory evaluations, vital signs, electrocardiograms at baseline and on Days 2, 4, 7, 14, 21, and 28. |  | 28 days | 
| Change from baseline to Day 28 in movement disorder rating scale scores. |  | 28 days |