A Double-blind and Randomized Trial of Celecoxib Added to Risperidone in Treatment-naive First-episode Schizophrenia

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

A double-blind, randomized, placebo-controlled trial of celecoxib as an add-on therapy to risperidone compared to risperidone plus placebo in the treatment of 200 treatment-naive first-episode patients with schizophrenia. The study addresses an immune dysfunction hypothesis of schizophrenia.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Beijing HuiLongGuan Hospital
• Collaborator: Stanley Medical Research Institute
• Treatments: Celecoxib; Risperidone

Criteria

Inclusion Criteria:

• Diagnosis of schizophrenia or schizophreniform disorder;

• Duration of symptoms not longer than 60 months;

• No prior treatment with antipsychotic medication or, if previously treated, a total lifetime usage of less than 14 days;

• Between 16 and 40 years of age; and

• Current psychotic symptoms of moderate severity.

Exclusion Criteria:

• A DSM-IV Axis I diagnosis other than schizophrenia or schizophreniform;

• Documented disease of the central nervous system that can interfere with the trial assessments including, but not limited to stroke, tumor, Parkinson's disease, Huntington's disease, seizure disorder, history of brain trauma resulting in significant impairment, chronic, infection;

• Acute, unstable and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension);

• A clinically significant ECG abnormality in the opinion of the investigator;

• Pregnant or breast-feeding female;

• Use of disallowed concomitant therapy;

• History of severe allergy or hypersensitivity.