Ginkgo Biloba Extract for 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 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|
- PANSS [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]PANSS
- CGI [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]
- Cognition [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2011|
|Study Completion Date:||August 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
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
twice a day, 10 weeks
Other Name: EGb761
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.
- 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.