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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00988663
Recruitment Status : Withdrawn (PI deceased; study did not start.)
First Posted : October 2, 2009
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Jerrry L Lewis, University of Iowa

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Major Depressive Disorder Drug: memantine Drug: Placebo Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Memantine Augmentation of Electroconvulsive Therapy in Patients With Major Depression
Actual Study Start Date : November 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of whether Memantine protects memory and cognitive impairment caused by ECT. [ Time Frame: 6 to 8 weeks ]

Secondary Outcome Measures :
  1. Whether memantine will improve response of Depression to Electroconvulsive therapy. [ Time Frame: 6-8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Meets criteria for Major Depressive disorder

Exclusion Criteria:

  • Neurological disease
  • Mental retardation
  • Seizure disorder
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00988663


Locations
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United States, Iowa
University of Iowa hosptitals and clinic
Iowa City, Iowa, United States, 50208
Sponsors and Collaborators
Jerrry L Lewis
Investigators
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Principal Investigator: Jerry L Lewis, MD University of Iowa Hospitals and Clinic
More Information
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Responsible Party: Jerrry L Lewis, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT00988663    
Other Study ID Numbers: Memantine ECT trial
First Posted: October 2, 2009    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017
Keywords provided by Jerrry L Lewis, University of Iowa:
electroconvulsive therapy
memantine
cognitive function
memory
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
 Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents