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

Phase 3

Terminated

• Conditions: Schizophrenia; Schizoaffective Disorder
• Interventions: Drug: Ziprasidone

• Registration Number: NCT00645229
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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 Timeline

• Study Start: 2004-09
• Study Completion: 2005-03
• Study First Submitted: 2008-03-25
• Study First Submitted QC: 2008-03-25
• Study First Posted: 2008-03-27
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A	Ziprasidone	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in Clinical Global Impressions-Severity (CGI-S) total score at Week 24	Week 24
Change from baseline in PANSS (Depression-C) score at Week 24	Week 24
Change from baseline in CGI-S total score at Week 24	Week 24
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 24	Week 24

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇵🇹 Lisboa, Portugal