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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00070954
First Posted: October 13, 2003
Last Update Posted: June 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by:
Medical University of South Carolina
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Ginkgo Biloba for ECT-induced Memory Deficits

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Modified Mini-Mental State Examination [ Time Frame: 2009 ]
  • Rey Auditory Verbal Learning Test [ Time Frame: 2009 ]
  • Autobiographical Memory Inventory [ Time Frame: 2003-2009 ]
  • Spitzer Uniscale of Quality of Life(Uni) [ Time Frame: 2--3-2009 ]
  • Health Status Questionnaire [ Time Frame: 2003-2009 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Integrative Health (NCCIH)
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: John S. Markowitz, Pharm.D., Medical Univ of SC
ClinicalTrials.gov Identifier: NCT00070954     History of Changes
Other Study ID Numbers: R21AT000939-01A1 ( U.S. NIH Grant/Contract )
First Submitted: October 9, 2003
First Posted: October 13, 2003
Last Update Posted: June 28, 2011
Last Verified: August 2008

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