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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Celecoxib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00639483

COXXNT-6570-001

A3191105

Details and patient eligibility

About

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

Enrollment: 270 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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270 participants in 2 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: Celecoxib

B

Placebo Comparator group

Treatment:

Drug: Placebo