Ginkgo Biloba to Improve Short-Term Memory Losses Associated With Electroconvulsive Therapy (ECT)

Study Overview
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Brief Summary
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Electroconvulsive therapy (ECT) is an effective treatment for severe or medication-resistant depression and other psychiatric disorders. A common side effect of ECT is problems with short-term memory during treatment. This study will test whether taking ginkgo biloba (GB) prior to and during the course of ECT will lessen the effects of ECT on short-term memory.

Detailed Description
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ECT is a safe and effective modern treatment for severe depression and other psychiatric conditions. An estimated 100,000 treatments occur per year in the United States. 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. Preliminary research has shown the herbal preparation GB aids cognitive function and memory in both patients with dementia and in normal volunteers. This study will investigate the utility and safety of GB to minimize the cognitive impairment typically associated with ECT. Participants in this study will be randomly assigned to receive either twice-daily GB or placebo. Participants will begin taking GB or placebo as soon as consent is obtained and baseline testing is completed in order to reach steady-state plasma levels of GB prior to ECT. Patients will undergo cognitive testing at specified intervals following ECT. The final study visit will occur one week after a participant's final ECT treatment.

Official Title
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Ginkgo Biloba for ECT-induced Memory Deficits

Conditions
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Memory, Short-Term

Intervention / Treatment
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* Drug: ginkgo biloba
* Other: matched placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria DSM-IV diagnosis of major depressive episode, unipolar or bipolar, without psychotic features Receiving ECT for depression Able to complete detailed neuropsychological testing Exclusion Criteria Psychotic symptoms Lifetime history of schizophrenia, schizoaffective disorder, or mental retardation Diagnosis of anxiety disorder, obsessive-compulsive disorder, or eating disorder within 1 year of study entry Delirium, dementia, or amnestic disorder Any active general medical condition or central nervous system disease which could affect cognition or response to treatment Diagnosis of active substance abuse or dependence within 6 months of study entry ECT within 6 months of study entry Known or suspected coagulation disorder Anticoagulation or antiplatelet medications, including warfarin, aspirin, clopidogrel, and ticlopidine Thiazide diuretics, selective serotonin reuptake inhibitors, trazodone, antipsychotic medications, herbal medications, or other nutritional supplements Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br>look-alike placebo | Other: matched placebo<br>* Inactive look-alike placebo<br>|
| Active Comparator: Ginkgo Biloba<br>Compared to placebo | Drug: ginkgo biloba<br>* EgB 761<br>* Other names: ginkgo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Mini-Mental State Examination |  | 2009 | 
| Rey Auditory Verbal Learning Test |  | 2009 | 
| Autobiographical Memory Inventory |  | 2003-2009 | 
| Spitzer Uniscale of Quality of Life(Uni) |  | 2--3-2009 | 
| Health Status Questionnaire |  | 2003-2009 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECT, Memory, Ginkgo biloba