NCT00070954

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2003

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2003

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
Last Updated

July 18, 2018

Status Verified

August 1, 2008

Enrollment Period

1.9 years

First QC Date

October 9, 2003

Last Update Submit

July 16, 2018

Conditions

Memory, Short-Term

Keywords

ECTMemoryGinkgo biloba

Outcome Measures

Primary Outcomes (5)

  • 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

  • Health Status Questionnaire

    2003-2009

Study Arms (2)

2

PLACEBO COMPARATOR

look-alike placebo

Other: matched placebo

Ginkgo Biloba

ACTIVE COMPARATOR

Compared to placebo

Drug: ginkgo biloba

Interventions

ginkgo bilobaDRUG

EgB 761

Also known as: ginkgo
Ginkgo Biloba
matched placeboOTHER

Inactive look-alike placebo

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DSM-IV diagnosis of major depressive episode, unipolar or bipolar, without psychotic features
  • Receiving ECT for depression
  • Able to complete detailed neuropsychological testing

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMDNJ - NJ Medical School

Newark, New Jersey, 29425, United States

Location

MeSH Terms

Interventions

Ginkgo Extract

Intervention Hierarchy (Ancestors)

Plant ExtractsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • John S. Markowitz, PharmD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

  • Charles H. Kellner, M.D.

    UMDNJ - NJ Medical School

    PRINCIPAL INVESTIGATOR

  • Thomas W Uhde, MD

    Medical University of South Carolina

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 9, 2003

First Posted

October 13, 2003

Study Start

February 1, 2003

Primary Completion

January 1, 2005

Study Completion

March 1, 2005

Last Updated

July 18, 2018

Record last verified: 2008-08

Locations

US(1)