Status:
COMPLETED
Ginkgo Biloba Extract for Schizophrenia
Lead Sponsor:
Beijing HuiLongGuan Hospital
Conditions:
Schizophrenia
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
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...
Detailed Description
OBJECTIVE: There is evidence that an excessive free radical production or oxidative stress may be involved in the pathophysiology of patients with schizophrenia. The investigators hypothesize that ant...
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 :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT01524380
Start Date
September 1 2011
End Date
August 1 2013
Last Update
July 12 2016
Active Locations (1)
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1
Beijing HuiLongGuan Hospital
Beijing, China, 100096