Ginkgo Biloba |
Ginkgo; Japanese Silver Apricot; Kew Tree; Maidenhair Tree; Yinhsing |
Clinical Trial: Ginkgo Biloba to Improve Short-Term Memory Losses Associated With Electroconvulsive Therapy (ECT)
This study has been completed.
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Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Memory, Short-Term | Drug: ginkgo biloba | Phase I Phase II |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Ginkgo biloba for ECT-induced Memory Deficits
Expected Total Enrollment: 50
Study start: February 2003
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.
Eligibility
Ages Eligible for Study: 55 Years and above, Genders Eligible for Study: Both
Criteria
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
Location Information
South Carolina
Medical University of South Carolina, Institute of Psychiatry, Charleston, South Carolina, 29425, United States
John S. Markowitz, PharmD, Principal Investigator, Medical University of South Carolina
More Information
Record last reviewed: April 2005
Last Updated: April 7, 2005
Record first received: October 9, 2003
ClinicalTrials.gov Identifier: NCT00070954
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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