Background: Electroconvulsive therapy (ECT) is a safe and effective modern treatment for severe depression and other specific psychiatric conditions. Although typically reserved for a subset of patients with the most severe illnesses and who have failed initial medication trials, an estimated 100,000 treatments occur per year in the US, and 1,000,000 per year worldwide with use increasing. ECT's most bothersome adverse effect is memory loss with all patients receiving ECT experiencing some degree of short term cognitive impairment. At present there are no known effective pharmacologic treatments to prevent or improve ECT-induced cognitive dysfunction. The herbal preparation Ginkgo biloba (GB) has been found, in a promising series of recent studies, to aid cognitive function and memory in both dementia and in normal volunteers. In the present proposal, we will investigate the utility and safety of GB to minimize the cognitive impairment typically associated with ECT.
Specific Aims : To assess the effect of GB in reducing the adverse cognitive effects of ECT, 2) To assess the safety and tolerability of GB. Research Design: The proposed double-blind, placebo-controlled, parallel design study will be carried out over a two year period in 40 patients and will assess the effectiveness and safety of a standardized form of GB (EGb 761,Teboninr) manufactured by Dr. Willmar Schwabe GmbH & Co. in a dose of 120 mg twice daily versus placebo in reducing the cognitive side effects of ECT treatment. Patients will begin taking active drug or placebo as soon as consent is obtained and baseline testing is completed, in an attempt to reach steady-state plasma levels of GB prior to ECT. Patients will undergo cognitive testing by a blinded rater in the three relevant domains of cognitive function (anterograde memory, retrograde memory, and acute orientation) at specified intervals following ECT. Groups will then be compared on measures of cognitive function, and the active drug group will be compared with published data regarding the memory effects of ECT. A standardized side effect scale will be employed to assess the tolerability of GB versus placebo. Future Studies: If, in this exploratory study it is found that GB exerts a protective effect on memory function in patients receiving ECT, future studies will utilize larger groups and additional cognitive tests will be incorporated to provide more definitive conclusions regarding efficacy, optimal dose and duration, persistence of effects, and safety and tolerability
