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

July 16, 2018 updated by: Medical University of South Carolina

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Newark, New Jersey, United States, 29425
        • UMDNJ - NJ Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
look-alike placebo
Other: matched placebo
Inactive look-alike placebo
Active Comparator: Ginkgo Biloba
Compared to placebo
Drug: ginkgo biloba
EgB 761
Other Names:
  • ginkgo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Study Chair: Thomas W Uhde, MD, Medical University of South Carolina
  • Principal Investigator: John S. Markowitz, PharmD, Medical University of South Carolina
  • Principal Investigator: Charles H. Kellner, M.D., UMDNJ - NJ Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

October 9, 2003

First Submitted That Met QC Criteria

October 10, 2003

First Posted (Estimate)

October 13, 2003

Study Record Updates

Last Update Posted (Actual)

July 18, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R21AT000939-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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