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Memantine to Reduce Neurocognitive Deficits Following Unilateral ECT for the Treatment of a Major Depression

Primary Purpose

Depressive Disorder, Major

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
memantine
Placebo Oral Capsule
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depressive Disorder, Major

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:: Meets DSM-IV criteria for Major Depressive Disorder 18 to 75 years of age and able to provide legal consent Referred to Stanford ECT service by treating physician for unilateral electroconvulsive therapy with inpatient hospitalization Competed process for consenting to the clinical use of ECT according to California State law Females of childbearing potential will be required to use a double-barrier method of contraception, which includes foam and either condom and diaphragm, IUD, and/or implant during study.
 Exclusion Criteria:- Treatment with ECT in the 6 months prior to screening Meets criteria for drug or alcohol abuse or dependence in the 6 months prior to screening Use of alcohol or illegal drugs within seven days of randomization or during study. Patients may be excluded for use during a period greater than 7 days, per study physician's discretion Presence of unstable or untreated cardiovascular disease, hypertension, or endocrine disorder as determined by the investigator use of antipsychotic, antidepressant, or other prescription medications unless dose is stable for at least 7 days prior to randomization. Use of any investigational treatment within 30 days of randomization Previous allergic reaction to memantine or drugs of similar chemical structure. Women who are pregnant or breastfeeding are not advised to participate in the research study Any neurological disorder or organic brain condition that would confound neurocognitive testing

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Oral Capsule

memantine

Arm Description

Patients received a placebo capsule starting the day before ECT begins and while receiving ECT

Patients receive memantine starting the day before ECT begins and while receiving ECT

Outcomes

Primary Outcome Measures

Memantine Effect on CVLT Long Term Recall After Right Unilateral ECT Treatment.
The California Verbal Learning Test Delayed Free Recall is a measure of episodic verbal learning and memory. These results are from the Free Recall subtest. In this test the subject must recall a list of 16 nouns after 20 minutes without cueing. It assesses auditory encoding, recall and recognition. Scores reflect the number of correct recall of the presented words, and scores are are then normalized by age. A higher score reflects better memory function.

Secondary Outcome Measures

Full Information

First Posted
September 14, 2005
Last Updated
August 28, 2019
Sponsor
Stanford University
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00186498
Brief Title
Memantine to Reduce Neurocognitive Deficits Following Unilateral ECT for the Treatment of a Major Depression
Official Title
Memantine as an Adjunctive Agent to Reduce Neurocognitive Deficits Following Unilateral ECT for the Treatment of a Severe Major Depressive Episode
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether taking the medication memantine reduces impairment of memory and attention associated with electroconvulsive therapy.
Detailed Description
The primary objective of this study is to determine whether the novel NMDA antagonist memantine, FDA approved for use in moderate to severe alzheimers dementia, may reduce the neurocognitive deficits associated with right unilateral ECT treatments in patients receiving ECT for a severe and relatively refractory Major Depressive episode. Our hypothesis is that the use of an NMDA antagonist would reduce intracellular calcium levels, and glutamatergic stimulation during ECT. This reduction in excitatory stimulation during ECT would reduce hippocampal and prefrontal neuronal endangerment and dysfunction, thereby reducing cognitive impairment associated with right unilateral ECT treatments. We also hypothesize that ACTH and cortisol levels will correlate with neurocognitive impairment in placebo treated subjects, but not in the memantine treated individuals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Oral Capsule
Arm Type
Placebo Comparator
Arm Description
Patients received a placebo capsule starting the day before ECT begins and while receiving ECT
Arm Title
memantine
Arm Type
Experimental
Arm Description
Patients receive memantine starting the day before ECT begins and while receiving ECT
Intervention Type
Drug
Intervention Name(s)
memantine
Other Intervention Name(s)
Nameda
Intervention Description
Patients received a memantine containing capsule starting the day before ECT begins and while receiving ECT
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Capsule
Other Intervention Name(s)
Sugar Pill
Intervention Description
Patients received a placebo capsule starting the day before ECT begins and while receiving ECT
Primary Outcome Measure Information:
Title
Memantine Effect on CVLT Long Term Recall After Right Unilateral ECT Treatment.
Description
The California Verbal Learning Test Delayed Free Recall is a measure of episodic verbal learning and memory. These results are from the Free Recall subtest. In this test the subject must recall a list of 16 nouns after 20 minutes without cueing. It assesses auditory encoding, recall and recognition. Scores reflect the number of correct recall of the presented words, and scores are are then normalized by age. A higher score reflects better memory function.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:: Meets DSM-IV criteria for Major Depressive Disorder 18 to 75 years of age and able to provide legal consent Referred to Stanford ECT service by treating physician for unilateral electroconvulsive therapy with inpatient hospitalization Competed process for consenting to the clinical use of ECT according to California State law Females of childbearing potential will be required to use a double-barrier method of contraception, which includes foam and either condom and diaphragm, IUD, and/or implant during study.
 Exclusion Criteria:- Treatment with ECT in the 6 months prior to screening Meets criteria for drug or alcohol abuse or dependence in the 6 months prior to screening Use of alcohol or illegal drugs within seven days of randomization or during study. Patients may be excluded for use during a period greater than 7 days, per study physician's discretion Presence of unstable or untreated cardiovascular disease, hypertension, or endocrine disorder as determined by the investigator use of antipsychotic, antidepressant, or other prescription medications unless dose is stable for at least 7 days prior to randomization. Use of any investigational treatment within 30 days of randomization Previous allergic reaction to memantine or drugs of similar chemical structure. Women who are pregnant or breastfeeding are not advised to participate in the research study Any neurological disorder or organic brain condition that would confound neurocognitive testing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugh Brent Solvason
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual data will be available

Learn more about this trial

Memantine to Reduce Neurocognitive Deficits Following Unilateral ECT for the Treatment of a Major Depression

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