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Ginkgo Biloba Extract for Schizophrenia

This study is currently recruiting participants.
Verified January 2012 by Beijing Hui-Long-Guan Hospital
Sponsor:
Information provided by (Responsible Party):
Xiang Yang Zhang, Beijing Hui-Long-Guan Hospital
ClinicalTrials.gov Identifier:
NCT01524380
First received: January 28, 2012
Last updated: February 1, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention
Schizophrenia
 Drug: Ginkgo biloba extract
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beijing Hui-Long-Guan Hospital:

Primary Outcome Measures:
  • PANSS [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]
    PANSS


Secondary Outcome Measures:
  • CGI [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]
  • Cognition [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: September 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Ginkgo biloba extract, antioxidant Drug: Ginkgo biloba extract
400mg/day, twice a day, 10 weeks
Other Name: EGb761
Placebo Comparator: Placebo Drug: Placebo
twice a day, 10 weeks
Other Name: EGb761

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01524380

Contacts
Contact: Xiang Y Zhang, MD, PhD +86-10-627115511 ext 6464 zhangxy9@gmail.com
Contact: DaChun Chen, MD +86-10-627115511 ext 6429 chendc1963@yahoo.com.cn

Locations
China
Beijing HuiLongGuan Hospital Recruiting
Beijing, China, 100096
Contact: Mei H Xiu, PhD     +86-10-62715511 ext 6464     xiumeihong79@gmail.com    
Contact: Zhiwei Wu, MD     +86-10-62715511 ext 6464     wuzhiweiaf@yahoo.cn    
Principal Investigator: Xiang Y Zhang            
Sub-Investigator: Dachun Chen, MD            
Sponsors and Collaborators
Beijing Hui-Long-Guan Hospital
Investigators
Principal Investigator: Xiang Y Zhang, MD/PhD Beijing HuiLongGuan Hospital
  More Information

Publications:

Responsible Party: Xiang Yang Zhang, co-Director, Psychiatric Research Center, Beijing Hui-Long-Guan Hospital
ClinicalTrials.gov Identifier: NCT01524380     History of Changes
Other Study ID Numbers: Sch-FEP-001
Study First Received: January 28, 2012
Last Updated: February 1, 2012
Health Authority: China: Beijing Municipal Science and Technology Commission

Keywords provided by Beijing Hui-Long-Guan Hospital:
Schizophrenia
clinical trial
risperidone
ginkgo biloba extract
antioxidant

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antioxidants
Risperidone
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Serotonin Antagonists
 Serotonin Agents
Neurotransmitter Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 16, 2013