Efficacy And Safety Of Ziprasidone In Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder, Including Patients With A Diagnosis Of Recent Onset
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Change from baseline in Clinical Global Impressions-Severity (CGI-S) total score at Week 24
Study Overview
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
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arm A
Intervention: Ziprasidone (Drug)
Outcomes
Primary Outcomes
Change from baseline in Clinical Global Impressions-Severity (CGI-S) total score at Week 24
Time Frame: Week 24
Change from baseline in PANSS (Depression-C) score at Week 24
Time Frame: Week 24
Change from baseline in CGI-S total score at Week 24
Time Frame: Week 24
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 24
Time Frame: Week 24
Secondary Outcomes
- 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)
- 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)
- Electrocardiogram(Screening and Month 4)
- Change from baseline in Clinical Global Impressions-Improvement (CGI-I) score at Week 24(Week 24)
- 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)
- 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)
- 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)
