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

Not Applicable

Completed

• Conditions: Depressive Disorder, Major
• Interventions: Drug: Placebo Oral Capsule; Drug: memantine

• Registration Number: NCT00186498
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-16
• Primary Completion: 2006-02
• Study Completion: 2008-02
• Results First Submitted: 2016-10-20
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-28
• Last Update Submitted: 2019-08-28
• Results First Posted: 2019-09-27
• Last Update Posted: 2019-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.


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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Oral Capsule	Placebo Oral Capsule	Patients received a placebo capsule starting the day before ECT begins and while receiving ECT
memantine	memantine	Patients receive memantine starting the day before ECT begins and while receiving ECT

Primary Outcome Measures

Name	Time	Method
Memantine Effect on CVLT Long Term Recall After Right Unilateral ECT Treatment.	30 days	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.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States