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

This study has been terminated.
Sponsor:
Collaborator:
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00070954
First received: October 9, 2003
Last updated: June 27, 2011
Last verified: August 2008
History of Changes
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Ginkgo Biloba for ECT-induced Memory Deficits

Resource links provided by NLM:

MedlinePlus related topics: Memory
U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

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
Study Completion Date: March 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
look-alike placebo
 Other: matched placebo
Inactive look-alike placebo
Active Comparator: Ginkgo Biloba
Compared to placebo
 Dietary Supplement: ginkgo biloba
EgB 761
Other Name: ginkgo

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
Newark, New Jersey, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
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

No publications provided

Responsible Party: John S. Markowitz, Pharm.D., Medical Univ of SC
ClinicalTrials.gov Identifier: NCT00070954     History of Changes
Other Study ID Numbers: R21 AT000939-01A1, R21AT000939-01A1
Study First Received: October 9, 2003
Last Updated: June 27, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:
ECT
Memory
Ginkgo biloba

ClinicalTrials.gov processed this record on May 23, 2013