The Impact of Memantine on Electroconvulsive Therapy (ECT): Will it Improve Response and Protect Against Cognitive Problems?
Overview[ - collapse ][ - ]
| 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 | Major Depressive Disorder |
| Intervention | Drug: memantine Drug: Placebo |
| Phase | N/A |
| Sponsor | University of Iowa |
| Responsible Party | University of Iowa |
| ClinicalTrials.gov Identifier | NCT00988663 |
| First Received | October 1, 2009 |
| Last Updated | October 1, 2009 |
| Last verified | October 2009 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 1, 2009 |
|---|---|
| Last Updated Date | October 1, 2009 |
| Start Date | November 2009 |
| Estimated Primary Completion Date | May 2012 |
| Current 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] |
| Current Secondary Outcome Measures | Whether memantine will improve response of Depression to Electroconvulsive therapy. [Time Frame: 6-8 weeks] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | The Impact of Memantine on Electroconvulsive Therapy (ECT): Will it Improve Response and Protect Against Cognitive Problems? |
|---|---|
| Official Title | Memantine Augmentation of Electroconvulsive Therapy in Patients With Major Depression |
| 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. |
| 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 |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Major Depressive Disorder |
| Intervention | Drug: memantine patient will receive 5mg daily for 7day then 10 mgm daily Other Names: NamendaDrug: Placebo will give placebo that looks like memantine |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Not yet recruiting |
|---|---|
| Estimated Enrollment | 50 |
| Estimated Completion Date | May 2012 |
| Estimated Primary Completion Date | November 2011 |
| Eligibility Criteria | Inclusion Criteria: - Meets criteria for Major Depressive disorder Exclusion Criteria: - Neurological disease - Mental retardation - Seizure disorder |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Contact: Jerry L. Lewis, MD 319-384 5630 jerry-lewis@uiowa.edu |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00988663 |
|---|---|
| Other Study ID Numbers | Memantine ECT trial |
| Has Data Monitoring Committee | Yes |
| Information Provided By | University of Iowa |
| Study Sponsor | University of Iowa |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Jerry L Lewis, MD University of Iowa Hospitals and Clinic |
| Verification Date | October 2009 |
Locations[ + expand ][ + ]
| University of Iowa hosptitals and clinic | Iowa City, Iowa, United States, 50208 Contact: Jerry L Lewis, MD | 319-384-5630 | jerry-lewis@uiowa.eduPrincipal Investigator: Jerry L Lewus, MD Not yet recruiting |
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