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

Memantine as an Adjunctive Agent to Reduce Neurocognitive Deficits Following Unilateral ECT for the Treatment of a Severe Major Depressive Episode

The purpose of this study is to determine whether taking the medication memantine reduces impairment of memory and attention associated with electroconvulsive therapy.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Drug: Placebo Oral Capsule; Drug: memantine

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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo Oral Capsule; Patients received a placebo capsule starting the day before ECT begins and while receiving ECT	Drug: Placebo Oral Capsule; Patients received a placebo capsule starting the day before ECT begins and while receiving ECT; Other Names: Sugar Pill
EXPERIMENTAL: memantine; Patients receive memantine starting the day before ECT begins and while receiving ECT	Drug: memantine; Patients received a memantine containing capsule starting the day before ECT begins and while receiving ECT; Other Names: Nameda

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Forest Laboratories

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (ACTUAL): February 1, 2006
• Study Completion (ACTUAL): February 1, 2008

Study Registration Dates

• First Submitted: September 14, 2005
• First Submitted That Met QC Criteria: September 14, 2005
• First Posted (ESTIMATE): September 16, 2005

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2019
• Last Update Submitted That Met QC Criteria: August 28, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Memantine
• Other Study ID Numbers: NAM-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual data will be available