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

Memory, Short-Term Clinical Trial

Official title:

Ginkgo Biloba for ECT-induced Memory Deficits

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00070954
• Other study ID #: R21AT000939-01A1
• Secondary ID: R21AT000939-01A1
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: February 2003
• Est. completion date: March 2005

Study information

• Verified date: August 2008
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: March 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Memory, Short-Term

Intervention

Drug:
• ginkgo biloba
EgB 761

Other:
• matched placebo
Inactive look-alike placebo

Locations

Country	Name	City	State
United States	UMDNJ - NJ Medical School	Newark	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Mini-Mental State Examination		2009
Primary	Rey Auditory Verbal Learning Test		2009
Primary	Autobiographical Memory Inventory		2003-2009
Primary	Spitzer Uniscale of Quality of Life(Uni)		2--3-2009
Primary	Health Status Questionnaire		2003-2009