Status:
COMPLETED
A Study of the Efficacy and Safety of Ziprasidone for the Treatment of 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
18-70 years
Phase:
PHASE4
Brief Summary
This study was conducted to examine the efficacy and tolerability of ziprasidone intramuscular (IM), and to assess the effect of switching from IM to oral ziprasidone for the treatment of acute exacer...
Eligibility Criteria
Inclusion
- Diagnosis of schizophrenia or schizoaffective disorder.
- Inpatients with acute exacerbation of psychotic symptoms.
- Patients with a minimum score of 40 on the BPRS scale (1-7).
Exclusion
- Concurrent treatment with antipsychotic agents at study drug initiation (within 12 hours prior to study drug initiation); for depot agents a period of two weeks or one cycle, whichever is the longer, must occur between last administration and study drug initiation.
- Treatment with antidepressants or mood stabilizers within 7 days of start of ziprasidone.
- Patients currently receiving clozapine.
- Patients at immediate risk of committing harm to self or others.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00650429
Start Date
October 1 2003
End Date
May 1 2005
Last Update
February 21 2021
Active Locations (4)
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1
Pfizer Investigational Site
Monterrey, Nuevo León, Mexico, 64800
2
Pfizer Investigational Site
DF, Mexico, 14420
3
Pfizer Investigational Site
Mexico City, Mexico, 14050
4
Pfizer Investigational Site
Mexico D F, Mexico, 14269