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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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The purpose of this study is to determine whether taking the medication memantine reduces impairment of memory and attention associated with electroconvulsive therapy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Oral Capsule | Placebo Comparator | Patients received a placebo capsule starting the day before ECT begins and while receiving ECT |
|
| memantine | Experimental | Patients receive memantine starting the day before ECT begins and while receiving ECT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| memantine | Drug | Patients received a memantine containing capsule starting the day before ECT begins and while receiving ECT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Memantine Effect on CVLT Long Term Recall After Right Unilateral ECT Treatment. | The California Verbal Learning Test Delayed Free Recall is a measure of episodic verbal learning and memory. These results are from the Free Recall subtest. In this test the subject must recall a list of 16 nouns after 20 minutes without cueing. It assesses auditory encoding, recall and recognition. Scores reflect the number of correct recall of the presented words, and scores are are then normalized by age. A higher score reflects better memory function. | 30 days |
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Inclusion Criteria::
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| Name | Affiliation | Role |
|---|---|---|
| Hugh Brent Solvason | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
No individual data will be available
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Patients over age 18 who are referred for ECT for unipolar or bipolar depression were screened and enrolled. All patients receive right unilateral lead placements, and otherwise the entire procedure would be delivered as per usual clinical care at our institution.
Patients who sign an informed consent for this study were screened for eligibility.
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| ID | Title | Description |
|---|---|---|
| FG000 | Memantine | Patients receiving memantine for 2 days before ECT for a total of 30 days |
| FG001 | Placebo | Patients receiving placebo for 2 days before ECT for a total of 30 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Memantine | Patients receive memantine starting the day before ECT begins and while receiving ECT memantine: Memantine vs placebo |
| BG001 | Placebo | Patients receive placebo starting the day before ECT begins and while receiving ECT memantine: Memantine vs placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Memantine Effect on CVLT Long Term Recall After Right Unilateral ECT Treatment. | The California Verbal Learning Test Delayed Free Recall is a measure of episodic verbal learning and memory. These results are from the Free Recall subtest. In this test the subject must recall a list of 16 nouns after 20 minutes without cueing. It assesses auditory encoding, recall and recognition. Scores reflect the number of correct recall of the presented words, and scores are are then normalized by age. A higher score reflects better memory function. | The subjects enrolled in the study had signed a consent to receive ECT treatment. | Posted | Mean | Standard Deviation | units on a scale | 30 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Memantine | Patients are randomized 1:1, memantine treatment is for 2 days before ECT for a total of 30 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hugh Brent Solvason | Stanford University | 650 776 4793 | solvason@stanford.edu |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008559 | Memantine |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo Oral Capsule | Drug | Patients received a placebo capsule starting the day before ECT begins and while receiving ECT |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Placebo |
Patients are randomized 1:1, placebo treatment is for 2 days before ECT for a total of 30 days |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Placebo | Patients are randomized 1:1, placebo treatment is for 2 days before ECT for a total of 30 days | 0 | 5 | 0 | 5 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |