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Ginkgo Biloba to Improve Short-Term Memory Losses Associated With Electroconvulsive Therapy (ECT)
This study is currently recruiting participants.
Study NCT00070954   Information provided by National Center for Complementary and Alternative Medicine (NCCAM)
First Received: October 9, 2003   Last Updated: August 14, 2008   History of Changes

October 9, 2003
August 14, 2008
February 2003
January 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • Modified Mini-Mental State Examination
  • Rey Auditory Verbal Learning Test
  • Autobiographical Memory Inventory
  • Spitzer Uniscale of Quality of Life(Uni)
  • Health Status Questionnaire
Complete list of historical versions of study NCT00070954 on ClinicalTrials.gov Archive Site
 
 
 
Ginkgo Biloba to Improve Short-Term Memory Losses Associated With Electroconvulsive Therapy (ECT)
Ginkgo Biloba for ECT-Induced Memory Deficits

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.

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.

Phase I, Phase II
Interventional
Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Memory, Short-Term
  • Dietary Supplement: ginkgo biloba
  • Other: matched placebo
  • Placebo Comparator: look-alike placebo
  • Active Comparator: Compared to placebo
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
50
March 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
 
United States
 
NCT00070954
John S. Markowitz, Pharm.D., Medical Univ of SC
R21 AT000939-01A1
National Center for Complementary and Alternative Medicine (NCCAM)
 
Principal Investigator: John S. Markowitz, PharmD Medical University of South Carolina
Principal Investigator: Charles H. Kellner, M.D. UMDNJ - NJ Medical School
National Center for Complementary and Alternative Medicine (NCCAM)
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP