Ginkgo Biloba Extract for Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ginkgo biloba extract
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, clinical trial, risperidone, ginkgo biloba extract, antioxidant
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.
Sites / Locations
- Beijing HuiLongGuan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ginkgo biloba extract, antioxidant
Placebo
Arm Description
Active treatment with Ginkgo biloba extract
Treatment with placebo
Outcomes
Primary Outcome Measures
PANSS
PANSS
Secondary Outcome Measures
CGI
Cognition
Full Information
NCT ID
NCT01524380
First Posted
January 28, 2012
Last Updated
July 10, 2016
Sponsor
Beijing HuiLongGuan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01524380
Brief Title
Ginkgo Biloba Extract for Schizophrenia
Official Title
A Double-blind and Randomized Trial of Ginkgo Biloba Extract Added to Risperidone in Treatment-naive First-episode Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing HuiLongGuan Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, clinical trial, risperidone, ginkgo biloba extract, antioxidant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ginkgo biloba extract, antioxidant
Arm Type
Active Comparator
Arm Description
Active treatment with Ginkgo biloba extract
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Treatment with placebo
Intervention Type
Drug
Intervention Name(s)
Ginkgo biloba extract
Other Intervention Name(s)
EGb761
Intervention Description
400mg/day, twice a day, 10 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
EGb761
Intervention Description
twice a day, 10 weeks
Primary Outcome Measure Information:
Title
PANSS
Description
PANSS
Time Frame
11 weeks
Secondary Outcome Measure Information:
Title
CGI
Time Frame
11 weeks
Title
Cognition
Time Frame
11 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiang Y Zhang, MD/PhD
Organizational Affiliation
Beijing HuiLongGuan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing HuiLongGuan Hospital
City
Beijing
ZIP/Postal Code
100096
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
11199954
Citation
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.
Results Reference
result
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Ginkgo Biloba Extract for Schizophrenia
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