Clinical trial NCT00070954: Ginkgo Biloba to Improve Short-Term Memory Losses Associated With Electroconvulsive Therapy (ECT)
Official title: Ginkgo Biloba for ECT-induced Memory Deficits
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Memory, Short-Term
Keywords: ECT
Memory
Ginkgo biloba
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2003-10-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Modified Mini-Mental State Examination
timeFrame: 2009
measure: Rey Auditory Verbal Learning Test
timeFrame: 2009
measure: Autobiographical Memory Inventory
timeFrame: 2003-2009
measure: Spitzer Uniscale of Quality of Life(Uni)
timeFrame: 2--3-2009
measure: Health Status Questionnaire
timeFrame: 2003-2009
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: UMDNJ - NJ Medical School
state: New Jersey
Study officials:
affiliation: Medical University of South Carolina
name: John S. Markowitz, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMDNJ - NJ Medical School
name: Charles H. Kellner, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Thomas W Uhde, MD
role: STUDY_CHAIR
References: