Status:
TERMINATED
A Study of the Efficacy and Safety of Ziprasidone in Patients With Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00645229
Start Date
September 1 2004
End Date
March 1 2005
Last Update
February 21 2021
Active Locations (1)
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1
Pfizer Investigational Site
Lisbon, Portugal, 1600-219