Memantine as an Adjunctive Agent to Reduce Neurocognitive Deficits Following Unilateral ECT for the Treatment of a Severe Major Depressive Episode
This trial is active, not recruiting.
|Condition||depressive disorder, major|
|Start date||February 2004|
|Trial size||20 participants|
|Trial identifier||NCT00186498, NAM-10|
The purpose of this study is to determine whether taking the medication memantine reduces impairment of memory and attention associated with electroconvulsive therapy.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Reduction the neurocognitive deficits associated with right unilateral ECT
Male or female participants from 18 years up to 75 years old.
Inclusion Criteria:: - Meets DSM-IV criteria for Major Depressive Disorder - 18 to 75 years of age and able to provide legal consent - Referred to Stanford ECT service by treating physician for unilateral electroconvulsive therapy with inpatient hospitalization - Competed process for consenting to the clinical use of ECT according to California State law - Females of childbearing potential will be required to use a double-barrier method of contraception, which includes foam and either condom and diaphragm, IUD, and/or implant during study. Exclusion Criteria:- Treatment with ECT in the 6 months prior to screening - Meets criteria for drug or alcohol abuse or dependence in the 6 months prior to screening - Use of alcohol or illegal drugs within seven days of randomization or during study. Patients may be excluded for use during a period greater than 7 days, per study physician's discretion - Presence of unstable or untreated cardiovascular disease, hypertension, or endocrine disorder as determined by the investigator - use of antipsychotic, antidepressant, or other prescription medications unless dose is stable for at least 7 days prior to randomization. - Use of any investigational treatment within 30 days of randomization - Previous allergic reaction to memantine or drugs of similar chemical structure. - Women who are pregnant or breastfeeding are not advised to participate in the research study - Any neurological disorder or organic brain condition that would confound neurocognitive testing
|Official title||Memantine as an Adjunctive Agent to Reduce Neurocognitive Deficits Following Unilateral ECT for the Treatment of a Severe Major Depressive Episode|
|Principal investigator||Hugh Brent Solvason|
|Description||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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