Memantine as an Adjunctive Agent to Reduce Neurocognitive Deficits Following Unilateral ECT for the Treatment of a Severe Major Depressive Episode
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Memantine Effect on CVLT Long Term Recall After Right Unilateral ECT Treatment.
研究概览
简要总结
The purpose of this study is to determine whether taking the medication memantine reduces impairment of memory and attention associated with electroconvulsive therapy.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.

排除标准
- •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
研究组 & 干预措施
Placebo Oral Capsule
Patients received a placebo capsule starting the day before ECT begins and while receiving ECT
干预措施: Placebo Oral Capsule (Drug)
memantine
Patients receive memantine starting the day before ECT begins and while receiving ECT
干预措施: memantine (Drug)
结局指标
主要结局
Memantine Effect on CVLT Long Term Recall After Right Unilateral ECT Treatment.
时间窗: 30 days
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.
次要结局
未报告次要终点
研究者
Hugh Brent Solvason
Principle Investigator
Stanford University