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

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00070954

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	Intervention	Phase
Memory, Short-Term	Dietary Supplement: ginkgo biloba Other: matched placebo	Phase I Phase II

MedlinePlus related topics: Memory

U.S. FDA Resources

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

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

Modified Mini-Mental State Examination [ Time Frame: 2009 ] [ Designated as safety issue: No ]
Rey Auditory Verbal Learning Test [ Time Frame: 2009 ] [ Designated as safety issue: No ]
Autobiographical Memory Inventory [ Time Frame: 2003-2009 ] [ Designated as safety issue: No ]
Spitzer Uniscale of Quality of Life(Uni) [ Time Frame: 2--3-2009 ] [ Designated as safety issue: No ]
Health Status Questionnaire [ Time Frame: 2003-2009 ] [ Designated as safety issue: Yes ]

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
2: Placebo Comparator look-alike placebo	Other: matched placebo Inactive look-alike placebo
Ginkgo Biloba: Active Comparator Compared to placebo	Dietary Supplement: ginkgo biloba EgB 761

Detailed Description:

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:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00070954

Locations

United States, New Jersey
UMDNJ - NJ Medical School	Recruiting
Newark, New Jersey, United States, 29425
Contact: Kristen Tobias 973-972-8259 tobiaskg@umdnj.edu

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:	John S. Markowitz, PharmD	Medical University of South Carolina
Principal Investigator:	Charles H. Kellner, M.D.	UMDNJ - NJ Medical School

More Information

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

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

ECT
Memory
Ginkgo biloba

Study placed in the following topic categories:

Amnesia

ClinicalTrials.gov processed this record on January 16, 2009