Schizophrenia Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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