Memory, Short-Term
Conditions
Keywords
ECT, Memory, Ginkgo biloba
Brief 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.
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.
Interventions
DRUGginkgo biloba
EgB 761
OTHERmatched placebo
Inactive look-alike placebo
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Health Status Questionnaire | 2003-2009 |
| Modified Mini-Mental State Examination | 2009 |
| Rey Auditory Verbal Learning Test | 2009 |
| Autobiographical Memory Inventory | 2003-2009 |
| Spitzer Uniscale of Quality of Life(Uni) | 2--3-2009 |
Countries
United States
Outcome results
None listed