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

Phase 3TerminatedNCT00645229

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Schizophrenia Schizoaffective Disorder

Interventions

ZiprasidoneDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

Lisbon, Portugal

Outcomes

Primary Outcomes

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

Time frame: Week 24

Change from baseline in CGI-S total score at Week 24

Time frame: Week 24

Secondary Outcomes

Vital signs and weight at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6

Time frame: 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

Time frame: Week 24

Adverse events on Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6

Time frame: 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

Time frame: Week 24

Laboratory parameters at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6

Time frame: 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

Time frame: Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6

Data from ClinicalTrials.gov

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