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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2005-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Memory, Short-Term

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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2

look-alike placebo

Group Type PLACEBO_COMPARATOR

matched placebo

Intervention Type OTHER

Inactive look-alike placebo

Ginkgo Biloba

Compared to placebo

Group Type ACTIVE_COMPARATOR

ginkgo biloba

Intervention Type DRUG

EgB 761

Interventions

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ginkgo biloba

EgB 761

Intervention Type DRUG

matched placebo

Inactive look-alike placebo

Intervention Type OTHER

Other Intervention Names

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ginkgo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No