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

• ClinicalTrials.gov Identifier: NCT00186498
• Recruitment Status: Completed
• First Posted: September 16, 2005
• Results First Posted: September 27, 2019
• Last Update Posted: September 27, 2019
• Sponsor: Stanford University
• Collaborator: Forest Laboratories
• Information provided by (Responsible Party): Hugh Brent Solvason, Stanford University

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.

Condition or disease	Intervention/treatment	Phase
Depressive Disorder, Major	Drug: memantine; Drug: Placebo Oral Capsule	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Memantine as an Adjunctive Agent to Reduce Neurocognitive Deficits Following Unilateral ECT for the Treatment of a Severe Major Depressive Episode
• Study Start Date: February 2004
• Actual Primary Completion Date: February 2006
• Actual Study Completion Date: February 2008

Arms and Interventions

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 Name: 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 Name: Nameda

Outcome Measures

Primary Outcome Measures :

1. Memantine Effect on CVLT Long Term Recall After Right Unilateral ECT Treatment. [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

Stanford University School of Medicine

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Forest Laboratories

Investigators

• Principal Investigator: Hugh Brent Solvason; Stanford University

More Information

• Responsible Party: Hugh Brent Solvason, Principle Investigator, Stanford University
• ClinicalTrials.gov Identifier: NCT00186498
• Other Study ID Numbers: NAM-10
• First Posted: September 16, 2005
• Results First Posted: September 27, 2019
• Last Update Posted: September 27, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No individual data will be available

Additional relevant MeSH terms:

Depressive Disorder; Depressive Disorder, Major; Mood Disorders; Mental Disorders; Memantine; Antiparkinson Agents; Anti-Dyskinesia Agents; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents