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

NCT ID: NCT00186498

Last Updated: 2019-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2008-02-29

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.

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.

Conditions

Depressive Disorder, Major

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Placebo Oral Capsule

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

Group Type: PLACEBO_COMPARATOR

Placebo Oral Capsule

Intervention Type: DRUG

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

memantine

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

Group Type: EXPERIMENTAL

memantine

Intervention Type: DRUG

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

Interventions

memantine

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

Intervention Type: DRUG

Placebo Oral Capsule

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

Intervention Type: DRUG

Other Intervention Names

Nameda; Sugar Pill

Eligibility 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Forest Laboratories

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Hugh Brent Solvason

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hugh Brent Solvason

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

NAM-10

Identifier Type: -

Identifier Source: org_study_id