Status:
COMPLETED
A Double-blind and Randomized Trial of Celecoxib Added to Risperidone in Treatment-naive First-episode Schizophrenia
Lead Sponsor:
Beijing HuiLongGuan Hospital
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 patient...
Detailed Description
OBJECTIVE: Evidences of high levels of activating cytokines in the CSF and signs of CNS inflammation have suggested that an inflammatory/immunological pathogenesis may exist in a subgroup of schizophr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00686140
Start Date
June 1 2006
End Date
March 1 2008
Last Update
July 12 2016
Active Locations (1)
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1
Beijing HuiLongGuan Hospital
Beijing, China, 100096