Ginkgo Biloba Extract for Schizophrenia
A Double-blind and Randomized Trial of Ginkgo Biloba Extract Added to Risperidone in Treatment-naive First-episode Schizophrenia
1 other identifier
interventional
124
1 country
1
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 first-episode patients with schizophrenia. The study addresses an immune dysfunction hypothesis of schizophrenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started Sep 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 28, 2012
CompletedFirst Posted
Study publicly available on registry
February 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedJuly 12, 2016
July 1, 2016
1.8 years
January 28, 2012
July 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PANSS
PANSS
11 weeks
Secondary Outcomes (2)
CGI
11 weeks
Cognition
11 weeks
Study Arms (2)
Ginkgo biloba extract, antioxidant
ACTIVE COMPARATORActive treatment with Ginkgo biloba extract
Placebo
PLACEBO COMPARATORTreatment with placebo
Interventions
400mg/day, twice a day, 10 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing HuiLongGuan Hospital
Beijing, 100096, China
Related Publications (1)
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. doi: 10.1097/00004714-200102000-00015.
PMID: 11199954RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiang Y Zhang, MD/PhD
Beijing HuiLongGuan Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- co-Director, Psychiatric Research Center
Study Record Dates
First Submitted
January 28, 2012
First Posted
February 2, 2012
Study Start
September 1, 2011
Primary Completion
June 1, 2013
Study Completion
August 1, 2013
Last Updated
July 12, 2016
Record last verified: 2016-07