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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Stanford University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186498
First received: September 14, 2005
Last updated: November 6, 2008
Last verified: October 2008
  Purpose

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


Condition Intervention
Depressive Disorder, Major
Drug: memantine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Reduction the neurocognitive deficits associated with right unilateral ECT

Estimated Enrollment: 20
Study Start Date: February 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00186498

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

No publications provided

ClinicalTrials.gov Identifier: NCT00186498     History of Changes
Other Study ID Numbers: NAM-10
Study First Received: September 14, 2005
Last Updated: November 6, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Memantine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014