Efficacy and Safety of Celecoxib as Add-on Therapy to Risperidone Versus Risperidone Alone in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2004-01-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the efficacy and safety of celecoxib as add-on therapy to risperidone versus risperidone alone in patients with schizophrenia

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Celecoxib; Risperidone

Criteria

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