- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00988663
The Impact of Memantine on Electroconvulsive Therapy (ECT): Will it Improve Response and Protect Against Cognitive Problems? (ECTAug)
March 21, 2017 updated by: Jerrry L Lewis
Memantine Augmentation of Electroconvulsive Therapy in Patients With Major Depression
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 50208
- University of Iowa hosptitals and clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Meets criteria for Major Depressive disorder
Exclusion Criteria:
- Neurological disease
- Mental retardation
- Seizure disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Memantine arm
Patient receiving ECT and Memantine
|
patient will receive 5mg daily for 7day then 10 mgm daily
Other Names:
|
Placebo Comparator: placebo
25 patients receiving ECT will will receive placebo
|
patient will receive 5mg daily for 7day then 10 mgm daily
Other Names:
will give placebo that looks like memantine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of whether Memantine protects memory and cognitive impairment caused by ECT.
Time Frame: 6 to 8 weeks
|
6 to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Whether memantine will improve response of Depression to Electroconvulsive therapy.
Time Frame: 6-8 weeks
|
6-8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jerry L Lewis, MD, University of Iowa Hospitals and Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2009
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
October 1, 2009
First Submitted That Met QC Criteria
October 1, 2009
First Posted (Estimate)
October 2, 2009
Study Record Updates
Last Update Posted (Actual)
March 24, 2017
Last Update Submitted That Met QC Criteria
March 21, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Mood Disorders
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Memantine
Other Study ID Numbers
- Memantine ECT trial
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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