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Completed

NCT Number: NCT00186498

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

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

Completed

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Memantine

Drug

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

Other names: Nameda

Placebo oral capsule

Drug

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

Other names: Sugar Pill

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Forest Laboratories

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2008
First posted
Sep 16, 2005
Registry last updated
Sep 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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