Ginkgo Biloba Extract for Schizophrenia

NCT ID: NCT01524380

Last Updated: 2016-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-08-31

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.

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ginkgo biloba extract, antioxidant

Active treatment with Ginkgo biloba extract

Group Type: ACTIVE_COMPARATOR

Ginkgo biloba extract

Intervention Type: DRUG

400mg/day, twice a day, 10 weeks

Placebo

Treatment with placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

twice a day, 10 weeks

Interventions

Ginkgo biloba extract

400mg/day, twice a day, 10 weeks

Intervention Type: DRUG

Placebo

twice a day, 10 weeks

Intervention Type: DRUG

Other Intervention Names

EGb761; EGb761

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing HuiLongGuan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiang Yang Zhang

co-Director, Psychiatric Research Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiang Y Zhang, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing HuiLongGuan Hospital

Locations

Beijing HuiLongGuan Hospital

Beijing, , China

Countries

China

References

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.

Reference Type: RESULT

PMID: 11199954 (View on PubMed)

Other Identifiers

Sch-FEP-001

Identifier Type: -

Identifier Source: org_study_id