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

• Drug: Celecoxib
  
  200 mg oral capsules twice daily as add-on therapy to risperidone twice daily (range 2-8 mg/day) for 11 weeks
• Drug: Placebo
  
  Matched oral placebo as add-on to risperidone twice daily (range 2-8 mg/day) for 11 weeks

• Experimental: A
  
  Intervention: Drug: Celecoxib
• Placebo Comparator: B
  
  Intervention: Drug: Placebo

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