Status:
COMPLETED
Efficacy and Safety of Celecoxib as Add-on Therapy to Risperidone Versus Risperidone Alone in Patients With Schizophrenia
Lead Sponsor:
Pfizer
Conditions:
Schizophrenia
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
To assess the efficacy and safety of celecoxib as add-on therapy to risperidone versus risperidone alone in patients with schizophrenia
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Diagnosis of schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders \[DSM\]-IV-TR criteria and made by a specialist in psychiatry) and acute exacerbation of schizophrenia requiring hospitalization
- Total PANSS score of ?60 at screening
- History of schizophrenia of ?10 years (from onset of prodromal symptoms)
- Exclusion criteria:
- Axis-I DSM-IV-TR diagnosis other than schizophrenia
- Less than a full cycle has lapsed at time of screening following the last injection of a depot antipsychotic
- Currently taking celecoxib or other selective cyclo-oxygenase 2 inhibitors, or other antiinflammatory medication
Exclusion
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2004
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00639483
Start Date
March 1 2003
End Date
January 1 2004
Last Update
March 16 2009
Active Locations (17)
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1
Pfizer Investigational Site
La Plata, Buenos Aires, Argentina, (1900)
2
Pfizer Investigational Site
Lanús, Buenos Aires, Argentina, 1824
3
Pfizer Investigational Site
La Plata, Pcia. de Buenos Aires, Argentina, 1900
4
Pfizer Investigational Site
PR, Curitiba, Brazil, 80520-000