NCT00566735已完成3 期
The Use of Galantamine HBr (Reminyl) in Electroconvulsive Therapy: Impact on Mood and Cognitive Functioning
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Number of Side Effects
研究概览
简要总结
The purpose of the study is to see if galantamine HBr (Razadyne) is safe and can help treat problems with thinking and memory caused by electroconvulsive therapy (ECT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Criteria to enter the study include males and females between the ages of 18-90 (females must be post menopausal) and a DSM-IV diagnosis of Major Depressive Disorder, Major Depressive Disorder with psychotic features, Bipolar Disorder, depressed type, or Schizoaffective Disorder, depressed type (19).
排除标准
- •DSM-IV diagnoses of dementia and its subtypes
- •Substance use disorder (active use within the last 6 months)
- •Organic mental disorders; seizure disorder
- •Unstable physical disorder or physical disorder judged to significantly affect the central nervous system function
- •A heart rate of <60
- •A systolic blood pressure < 90
- •Heart block
- •Pre-existing sick-sinus
- •Chronic treatment with beta blockers
- •Any cardiac arrythmia
- •Hypotension
- •Coronary artery disease
- •Liver and renal function impairment
- •Urge incontinence, colitis Crohn's disease, GI motility disorders, asthma and COPD
- •Treatment with anti-cholinergic and cholinomimetic medications; and
- •Female patients who are pregnant.
- •Additionally, women subjects must be postmenopausal, surgically sterile, or using prescription oral contraceptives (e.g. estrogen-progestin combinations) , contraceptive implants (e.g. NorplantTM, DepoProveraTM ), or transdermally delivered contraceptives (Ortho EvraTM) before entry and throughout the study; and have a negative serum b-HCG pregnancy test at screening.
- •Note: Abstinence and the use of double barrier contraceptive methods are not acceptable in this study.
研究组 & 干预措施
1
Placebo Comparator
干预措施: Placebo (Drug)
2, Galantamine
Active Comparator
干预措施: Razadyne (Drug)
结局指标
主要结局
Number of Side Effects
时间窗: Participants were followed for the duration of hospital stay, an average of 3 weeks
This measure refers to the number of reported side effects experienced by participants during the study. The side effects were nausea, headache, dizziness, diarrhea, and vomiting.
次要结局
- Cognitive Functioning(Participants were questioned at baseline and after their last electroconvulsive therapy treatment)
- Baseline Depressive Symptoms(Participants were questioned at baseline)
研究者
John D. Matthews
Principal Investigator
Massachusetts General Hospital
研究点 (1)
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