A Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy of Celecoxib as Add-on Therapy to Risperidone Versus Risperidone Alone in Patients With Schizophrenia

CompletadoFase 2ClinicalTrials.gov

ID: NCT00639483Tipo: INTERVENTIONALInicio: 1 de mar de 2003Fin estimado: 1 de ene de 2004

Traducción no disponible, mostrando original

Resumen

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

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 50 YearsSexo: ALL

Criterios de inclusión

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)

Criterios de exclusión

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

Intervenciones

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

Ubicaciones

Pfizer Investigational Site

La Plata, Buenos Aires, Argentina

Pfizer Investigational Site

Lanús, Buenos Aires, Argentina

Pfizer Investigational Site

La Plata, Pcia. de Buenos Aires, Argentina

Patrocinadores

PrincipalPfizer

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