Schizophrenia Clinical Trial
Official title:
A Double-blind and Randomized Trial of Ginkgo Biloba Extract Added to Risperidone in Treatment-naive First-episode Schizophrenia
A double-blind, randomized, placebo-controlled trial of ginkgo biloba extract (Egb-761) 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.
Status | Completed |
Enrollment | 124 |
Est. completion date | August 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Beijing HuiLongGuan Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing HuiLongGuan Hospital |
China,
Zhang XY, Zhou DF, Su JM, Zhang PY. The effect of extract of ginkgo biloba added to haloperidol on superoxide dismutase in inpatients with chronic schizophrenia. J Clin Psychopharmacol. 2001 Feb;21(1):85-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PANSS | PANSS | 11 weeks | Yes |
Secondary | CGI | 11 weeks | Yes | |
Secondary | Cognition | 11 weeks | Yes |
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