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Ginkgo Biloba Extract for Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01524380
Recruitment Status : Completed
First Posted : February 2, 2012
Last Update Posted : July 12, 2016
Information provided by (Responsible Party):
Xiang Yang Zhang, Beijing HuiLongGuan Hospital

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Ginkgo biloba extract Drug: Placebo Not Applicable

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 antioxidant therapy by using an add-on agent together with a well-proven antipsychotic drug may have favorable effects on some schizophrenic patients.


  1. Clinical Trial: This is a randomized, double-blind and parallel controlled trial in treatment-naive first-episode patients with schizophrenia. The study consists of a 1-week stabilization phase, followed by 10 weeks of double-blind treatment. The total trial duration is 11 weeks.
  2. Medications: Eligible patients are randomly assigned to either capsulized EGb( or identically capsulized placebo addition to the risperidone (2-6mg/day) in a double-blind fashion.
  3. Assessment Procedures:

3.1. Primary Outcome Variable-psychopathology: Assessment instruments include the Positive and Negative Syndrome Scale (PANSS), and the Clinical Global Impression (CGI). Patients are interviewed at screening, at baseline and at every two weeks.

3.2. Cognitive tests: A comprehensive battery of tests encompassing the cognitive domains of executive function, attention, memory, perception, and general intellect is administered twice at baseline and at the end of 10-week treatment by a trained psychologist. Scoring follows standardized procedures.

3.3. Side Effects: Parkinsonism is rated with the Simpson-Angus Scale for extrapyramidal side effects. The Abnormal Involuntary Movement Scale (AIMS) is chosen to assess tardive dyskinesia (TD) severity. All of the AIMS and Simpson-Angus Rating Scales are administered by the same investigator at baseline and at baseline, and at week 5 and at week 10.

3.4. Plasma Measures: Venous blood from forearm vein is collected from healthy controls and patients with schizophrenia between 7 and 9 a.m. following an overnight fast. Serum Plasma malondialdehyde (MDA) levels and superoxide dismutase (SOD), glutathione peroxidase (GSH-Px) and catalase (CAT) activities will be analyzed using established procedures.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind and Randomized Trial of Ginkgo Biloba Extract Added to Risperidone in Treatment-naive First-episode Schizophrenia
Study Start Date : September 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Active Comparator: Ginkgo biloba extract, antioxidant
Active treatment with Ginkgo biloba extract
Drug: Ginkgo biloba extract
400mg/day, twice a day, 10 weeks
Other Name: EGb761

Placebo Comparator: Placebo
Treatment with placebo
Drug: Placebo
twice a day, 10 weeks
Other Name: EGb761

Primary Outcome Measures :
  1. PANSS [ Time Frame: 11 weeks ]

Secondary Outcome Measures :
  1. CGI [ Time Frame: 11 weeks ]
  2. Cognition [ Time Frame: 11 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01524380

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Beijing HuiLongGuan Hospital
Beijing, China, 100096
Sponsors and Collaborators
Beijing HuiLongGuan Hospital
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Principal Investigator: Xiang Y Zhang, MD/PhD Beijing HuiLongGuan Hospital
Publications of Results:
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Responsible Party: Xiang Yang Zhang, co-Director, Psychiatric Research Center, Beijing HuiLongGuan Hospital Identifier: NCT01524380    
Other Study ID Numbers: Sch-FEP-001
First Posted: February 2, 2012    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016
Keywords provided by Xiang Yang Zhang, Beijing HuiLongGuan Hospital:
clinical trial
ginkgo biloba extract
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders