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Clinical Trials/NCT00645229
NCT00645229TerminatedPhase 3

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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country1 target enrollmentStarted: September 2004Last updated:
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Conditions
Interventions
Drugs

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 OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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

Experimental

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)

Investigators

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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