Ginkgo Biloba Extract for Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Ginkgo biloba extract; Drug: Placebo

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.

METHODS:

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(240mg.day) 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.

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100096
    • Beijing HuiLongGuan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Treatment with placebo	Drug: Placebo; twice a day, 10 weeks; Other Names: EGb761
Active Comparator: Ginkgo biloba extract, antioxidant; Active treatment with Ginkgo biloba extract	Drug: Ginkgo biloba extract; 400mg/day, twice a day, 10 weeks; Other Names: EGb761

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PANSS	PANSS	11 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
CGI	11 weeks
Cognition	11 weeks

Collaborators and Investigators

• Sponsor: Beijing HuiLongGuan Hospital
• Investigators: Principal Investigator: Xiang Y Zhang, MD/PhD, Beijing HuiLongGuan Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: January 28, 2012
• First Submitted That Met QC Criteria: February 1, 2012
• First Posted (Estimate): February 2, 2012

Study Record Updates

• Last Update Posted (Estimate): July 12, 2016
• Last Update Submitted That Met QC Criteria: July 10, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Schizophrenia; risperidone; clinical trial; antioxidant; ginkgo biloba extract
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: Sch-FEP-001