Optimization of Electroconvulsive Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 340
- 试验地点
- 4
- 主要终点
- Neurocognitive battery
研究概览
简要总结
This study will evaluate the effectiveness of electroconvulsive therapy (ECT) administered with medication for the treatment of a major depressive episode (unipolar or bipolar) and will compare two types of ECT.
详细描述
This study addresses 2 issues in the optimization of ECT in patients with major depression: whether patients treated with ECT should receive concurrent treatment with antidepressant medications, and the relative efficacy and side effects of high dosage right unilateral (RUL) ECT compared to low dosage bilateral (BL) ECT.
This study has 2 phases. In Phase I, patients are randomized to receive nortriptyline, venlafaxine (Effexor), or placebo while they simultaneously receive either high dosage RUL ECT or low dosage BL ECT. Patients have an electrocardiogram (EKG), a chest x-ray, medical and neurological examinations, and blood tests. Memory function is assessed before and after ECT. Whenever feasible, patients are withdrawn from all prior psychotropic medication before the start of ECT. ECT is administered 3 times per week to inpatients and twice a week to outpatients. Patients continue ECT until they are asymptomatic or until there is a plateau in improvement over 2 treatments.
Patients who respond to ECT enter Phase II and add lithium to either nortriptyline or venlafaxine within 1-3 days of the last ECT. Clinical and side effect evaluations and blood level determinations are conducted weekly for the first month, every 2 weeks until Week 12, and every 4 weeks for the remaining 12 weeks. Following any indication of relapse, patients are monitored more intensively and are re-evaluated within 1 week. The neurocognitive battery is readministered to all patients at 2 and 6 months after the acute ECT course, regardless of ECT clinical outcome.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major depressive episode (unipolar or bipolar)
- •Pre-ECT score of 20 or higher on Hamilton Rating Scale for Depression
- •Able to withdraw psychotropic drugs (up to 3 mg/day lorazepam allowed)
- •ECT indicated
排除标准
- •Schizophrenia, schizoaffective disorder, or other psychosis
- •Amnestic disorder, dementia, or delirium
- •Pregnancy
- •Current alcohol or substance abuse or dependence
- •CNS disease or brain injury not associated with psychotropic drug exposure
- •ECT in the past 6 months
- •Medical contraindication for treatment with either nortriptyline or venlafaxine, including allergy to amitriptyline, nortriptyline, or venlafaxine; narrow angle glaucoma; sinus node disease; bundle branch disease; myocardial infarction; coronary artery bypass or angioplasty; or angina
- •Type I antiarrhythmic medication
- •Supine blood pressure >= 170 mmHg systolic or >= 105 mmHg diastolic at 3 readings over 2 days
研究组 & 干预措施
High dosage ECT + nortriptyline
Participants will receive nortriptyline and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment.
干预措施: High dosage electroconvulsive therapy (Procedure)
High dosage ECT + nortriptyline
Participants will receive nortriptyline and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment.
干预措施: Nortriptyline (Drug)
High dosage ECT + placebo
Participants will receive placebo and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment weeks.
干预措施: Lithium (Drug)
Low dosage ECT + nortriptyline
Participants will receive nortriptyline and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment.
干预措施: Nortriptyline (Drug)
High dosage ECT + nortriptyline
Participants will receive nortriptyline and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment.
干预措施: Lithium (Drug)
High dosage ECT + venlafaxine
Participants will receive venlafaxine and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment.
干预措施: High dosage electroconvulsive therapy (Procedure)
High dosage ECT + venlafaxine
Participants will receive venlafaxine and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment.
干预措施: Venlafaxine (Drug)
High dosage ECT + venlafaxine
Participants will receive venlafaxine and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment.
干预措施: Lithium (Drug)
High dosage ECT + placebo
Participants will receive placebo and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment weeks.
干预措施: High dosage electroconvulsive therapy (Procedure)
Low dosage ECT + nortriptyline
Participants will receive nortriptyline and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment.
干预措施: Lithium (Drug)
Low dosage ECT + nortriptyline
Participants will receive nortriptyline and high dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment.
干预措施: Low dosage electroconvulsive therapy (Procedure)
Low dosage ECT + venlafaxine
Participants will receive venlafaxine and low dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment.
干预措施: Venlafaxine (Drug)
Low dosage ECT + venlafaxine
Participants will receive venlafaxine and low dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment.
干预措施: Lithium (Drug)
Low dosage ECT + venlafaxine
Participants will receive venlafaxine and low dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment.
干预措施: Low dosage electroconvulsive therapy (Procedure)
Low dosage ECT + placebo
Participants will receive placebo and low dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment weeks.
干预措施: Lithium (Drug)
Low dosage ECT + placebo
Participants will receive placebo and low dosage ECT. If the ECT is effective participants will receive lithium after ECT treatment weeks.
干预措施: Low dosage electroconvulsive therapy (Procedure)
结局指标
主要结局
Neurocognitive battery
时间窗: Measured at baseline and at 2 and 6 months after the acute ECT course
Clinical evaluations, side effect evaluations, and blood level determinations
时间窗: Measured weekly for the first month, every 2 weeks until Week 12, and every 4 weeks for the remaining 12 weeks
次要结局
- Memory function(Measured before and after ECT)