Status:
COMPLETED
A Study of the Efficacy and Safety of Intramuscular Ziprasidone Followed by Oral Ziprasidone for the Treatment of Psychosis
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Schizophrenia
Mania
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
To assess the efficacy, safety, and tolerability of intramuscular ziprasidone in the treatment of the acute exacerbation of non-organic psychosis of any etiology, including schizophrenia, acute mania,...
Eligibility Criteria
Inclusion
- Hospitalized patients with psychosis
- Eligible for intramuscular treatment
- Miminum score of 60 on the PANSS, a score of 14 in the sum of PANSS excitation score and a score of at least 4 in 1 of the following items: poor control of impulses, tension, hostility, uncooperativeness or excitation.
Exclusion
- Treatment with antidepressants or mood stabilizers within seven days prior to the enrollment; for monoamine oxidase inhibitors (MAOIs) and moclobemide, this period must be two weeks; for fluoxetine, five weeks
- Resistance to conventional antipsychotic agents
- A history of epilepsy
- A diagnosis of abuse of substance within the previous 3 months according to the DSMIV criteria.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2004
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00644800
Start Date
July 1 2003
End Date
May 1 2004
Last Update
February 21 2021
Active Locations (8)
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1
Pfizer Investigational Site
Fortaleza, Ceará, Brazil, 60175-270
2
Pfizer Investigational Site
Salvador, Estado de Bahia, Brazil, 41180-000
3
Pfizer Investigational Site
Belo Horizonte, Minas Gerais, Brazil, 30150-270
4
Pfizer Investigational Site
Curitiba, Paraná, Brazil