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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00070954 |
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 | Intervention | Phase |
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Memory, Short-Term |
Dietary Supplement: ginkgo biloba Other: matched placebo |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Ginkgo Biloba for ECT-Induced Memory Deficits |
Estimated Enrollment: | 50 |
Study Start Date: | February 2003 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Placebo Comparator
look-alike placebo
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Other: matched placebo
Inactive look-alike placebo
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Ginkgo Biloba: Active Comparator
Compared to placebo
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Dietary Supplement: ginkgo biloba
EgB 761
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
United States, New Jersey | |
UMDNJ - NJ Medical School | Recruiting |
Newark, New Jersey, United States, 29425 | |
Contact: Kristen Tobias 973-972-8259 tobiaskg@umdnj.edu |
Principal Investigator: | John S. Markowitz, PharmD | Medical University of South Carolina |
Principal Investigator: | Charles H. Kellner, M.D. | UMDNJ - NJ Medical School |
Responsible Party: | Medical Univ of SC ( John S. Markowitz, Pharm.D. ) |
Study ID Numbers: | R21 AT000939-01A1 |
Study First Received: | October 9, 2003 |
Last Updated: | August 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00070954 |
Health Authority: | United States: Food and Drug Administration |
ECT Memory Ginkgo biloba |
Amnesia |