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

Depressive Disorder, Major Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00186498
• Other study ID #: NAM-10
• Status: Completed
• Phase: N/A
• Start date: February 2004
• Est. completion date: February 2008

Study information

• Verified date: August 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 2008
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• memantine
Patients received a memantine containing capsule starting the day before ECT begins and while receiving ECT
• Placebo Oral Capsule
Patients received a placebo capsule starting the day before ECT begins and while receiving ECT

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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