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The Impact of Memantine on Electroconvulsive Therapy (ECT): Will it Improve Response and Protect Against Cognitive Problems? (ECTAug)

Primary Purpose

Major Depressive Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
memantine
Placebo
Sponsored by
Jerrry L Lewis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring electroconvulsive therapy, memantine, cognitive function, memory

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Meets criteria for Major Depressive disorder

Exclusion Criteria:

  • Neurological disease
  • Mental retardation
  • Seizure disorder

Sites / Locations

  • University of Iowa hosptitals and clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Memantine arm

placebo

Arm Description

Patient receiving ECT and Memantine

25 patients receiving ECT will will receive placebo

Outcomes

Primary Outcome Measures

Assessment of whether Memantine protects memory and cognitive impairment caused by ECT.

Secondary Outcome Measures

Whether memantine will improve response of Depression to Electroconvulsive therapy.

Full Information

First Posted
October 1, 2009
Last Updated
March 21, 2017
Sponsor
Jerrry L Lewis
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1. Study Identification

Unique Protocol Identification Number
NCT00988663
Brief Title
The Impact of Memantine on Electroconvulsive Therapy (ECT): Will it Improve Response and Protect Against Cognitive Problems?
Acronym
ECTAug
Official Title
Memantine Augmentation of Electroconvulsive Therapy in Patients With Major Depression
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Withdrawn
Why Stopped
PI deceased; study did not start.
Study Start Date
November 2009 (Actual)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jerrry L Lewis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether memantine will enhance the therapeutic of effect on depression and prevent memory and other cognitive problems caused by ECT.
Detailed Description
Patients will be assigned randomly either to a treatment group or a placebo groups. All patients in both groups will be receiving standard ECT. The treatment group will receive memantine. All patients will be given a battery of cognitive tests and test of depression before ECT treatments start, after the 6th ECT treatment and after the completions of ECT. An analysis will be performed to see if memantine causes any impact on the response to ECT and prevents memory and cognitive impairment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
electroconvulsive therapy, memantine, cognitive function, memory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Memantine arm
Arm Type
Active Comparator
Arm Description
Patient receiving ECT and Memantine
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
25 patients receiving ECT will will receive placebo
Intervention Type
Drug
Intervention Name(s)
memantine
Other Intervention Name(s)
Namenda
Intervention Description
patient will receive 5mg daily for 7day then 10 mgm daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
will give placebo that looks like memantine
Primary Outcome Measure Information:
Title
Assessment of whether Memantine protects memory and cognitive impairment caused by ECT.
Time Frame
6 to 8 weeks
Secondary Outcome Measure Information:
Title
Whether memantine will improve response of Depression to Electroconvulsive therapy.
Time Frame
6-8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Meets criteria for Major Depressive disorder Exclusion Criteria: Neurological disease Mental retardation Seizure disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerry L Lewis, MD
Organizational Affiliation
University of Iowa Hospitals and Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa hosptitals and clinic
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
50208
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Impact of Memantine on Electroconvulsive Therapy (ECT): Will it Improve Response and Protect Against Cognitive Problems?

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