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

NCT00186498 | Completed Results

• 1 other identifier: NAM-10
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Placebo Oral Capsule

PLACEBO COMPARATOR

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

Drug: Placebo Oral Capsule

memantine

EXPERIMENTAL

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

Drug: memantine

Interventions

memantine DRUG

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

Also known as: Nameda

memantine

Placebo Oral Capsule DRUG

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

Also known as: Sugar Pill

Placebo Oral Capsule

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets DSM-IV criteria for Major Depressive Disorder
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Forest Laboratories: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Memantine; Sugars

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Carbohydrates

Results Point of Contact

• Title: Dr. Hugh Brent Solvason
• Organization: Stanford University

solvason@stanford.edu

650 776 4793

Study Officials

• Hugh Brent Solvason

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 16, 2005
• Study Start: February 1, 2004
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2008
• Last Updated: September 27, 2019
• Results First Posted: September 27, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)