The Impact of Memantine on Electroconvulsive Therapy (ECT): Will it Improve Response and Protect Against Cognitive Problems? (ECTAug)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University of Iowa.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00988663
First received: October 1, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

The purpose of this study is to determine whether memantine will enhance the therapeutic of effect on depression and prevent memory and other cognitive problems caused by ECT.


Condition Intervention
Major Depressive Disorder
Drug: memantine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Memantine Augmentation of Electroconvulsive Therapy in Patients With Major Depression

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Assessment of whether Memantine protects memory and cognitive impairment caused by ECT. [ Time Frame: 6 to 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Whether memantine will improve response of Depression to Electroconvulsive therapy. [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2009
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Memantine arm
Patient receiving ECT and Memantine
Drug: memantine
patient will receive 5mg daily for 7day then 10 mgm daily
Other Name: Namenda
Placebo Comparator: placebo
25 patients receiving ECT will will receive placebo
Drug: memantine
patient will receive 5mg daily for 7day then 10 mgm daily
Other Name: Namenda
Drug: Placebo
will give placebo that looks like memantine

Detailed Description:

Patients will be assigned randomly either to a treatment group or a placebo groups. All patients in both groups will be receiving standard ECT. The treatment group will receive memantine. All patients will be given a battery of cognitive tests and test of depression before ECT treatments start, after the 6th ECT treatment and after the completions of ECT. An analysis will be performed to see if memantine causes any impact on the response to ECT and prevents memory and cognitive impairment.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Meets criteria for Major Depressive disorder

Exclusion Criteria:

  • Neurological disease
  • Mental retardation
  • Seizure disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988663

Contacts
Contact: Jerry L. Lewis, MD 319-384 5630 jerry-lewis@uiowa.edu
Contact: Laurie M McCormick, MD 319-384-7136 laurie-mccormick@uiowa.edu

Locations
United States, Iowa
University of Iowa hosptitals and clinic Not yet recruiting
Iowa City, Iowa, United States, 50208
Contact: Jerry L Lewis, MD    319-384-5630    jerry-lewis@uiowa.edu   
Contact: Laurie M McCormick, MD    319-384-7136    laruie-mccormick@uiowa.edu   
Principal Investigator: Jerry L Lewus, MD         
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Jerry L Lewis, MD University of Iowa Hospitals and Clinic
  More Information

No publications provided

Responsible Party: Jerry Lewis MD, professor of psychiatry, Univery of Iowa Hospitals and Clinics
ClinicalTrials.gov Identifier: NCT00988663     History of Changes
Other Study ID Numbers: Memantine ECT trial
Study First Received: October 1, 2009
Last Updated: October 1, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
electroconvulsive therapy
memantine
cognitive function
memory

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

ClinicalTrials.gov processed this record on September 30, 2014