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

Medical University of South Carolina (MUSC)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Memory, Short-Term

Treatments: Drug: ginkgo biloba; Other: matched placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00070954

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

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

2

Placebo Comparator group

Description:

look-alike placebo

Treatment:

Other: matched placebo

Ginkgo Biloba

Active Comparator group

Description:

Compared to placebo

Treatment:

Drug: ginkgo biloba