Preventing Relapse After Successful Electroconvulsive Therapy for Depression. A Randomized Controlled Trial on Lithium as add-on to Personalized Maintenance ECT.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Relapse Rate
研究概览
简要总结
The present project is designed to study two promising relapse prevention strategies in an RCT. This will be the first project worldwide to study the effects of a personalized ECT treatment algorithm in the continuation phase of depression in an ECT-responsive population of all ages. The project holds promise for diminishing relapse rates after successful ECT, thereby being of potential impact for a vulnerable group of patients with an often-recurring form of major depressive disorder. The underinvestigated role of lithium after successful ECT is the focus of our project. In order to improve implementation options, the investigators assess self-rating of mood alongside clinician-ratings. To investigate the effectiveness of these strategies, a multidisciplinary research project with partners from UAntwerp as well as PZ Duffel, KULeuven, AZ Sint-Jan in Brugge and our Dutch partner UMC Rotterdam was set up. With the expertise, skills and patients available at the consortium participants, the research team will be able to address the challenges of the project in terms of planning and organization of the treatment and testings. This is a completely clinical study with the intent to decrease relapse rates after successful ECT. The concrete scientific objectives (SO) will be the following:
- SO1: Investigate the additive effect of lithium-addition to symptom-driven M-ECT and antidepressant treatment in preventing relapse after successful ECT.
- SO2: Validate the effectiveness of a personalized, symptom-driven approach of maintenance ECT (for 6 months) in depressive patients that have responded to an acute ECT-course.
- SO3: Compare clinician-rated mood with scores on self-rating scales.
- SO4: Evaluate the tolerability of combined continuation treatment in the two different treatment arms by assessment of cognitive functioning.
详细描述
Although electroconvulsive therapy (ECT) is a very effective acute treatment for (unipolar as well as bipolar) major depression, one of the major challenges in the treatment of mood disorders is to prevent relapse after successful treatment. Without continuation treatment, up to 50% of patients will relapse within 3 months after the last treatment and 6 months relapse rates are as high as 80%.
Several strategies have been used to decrease these relapse rates. The most commonly used strategy, pharmacological treatment with antidepressants, decrease 6-month relapse rates by 30%.
Nevertheless, as nearly half of patients on antidepressants will relapse within one year after successful ECT, relapse prevention remains a major challenge.
Treatment of patients:
Antidepressants:
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
- Single (Outcomes Assessor)
盲法说明
Raters did not receive information about treatment group while handling the questionnaires.
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 disorder patients
- •Treatment with either an adequately dosed TCA (with therapeutic blood levels) or venlafaxine (target dose of ≥ 225mg/day)
- •Remitted (IDS-C≤12) after an acute course of ECT
- •Age 18 or older
- •If applicable, use of appropriate contraception.
排除标准
- •Patients with bipolar, schizoaffective disorder or schizophrenia
- •Patients already being treated with Lithium, or with a contra-indication for its use
- •Patients with documented dementia or intellectual disability
- •Substance abuse or dependence in the past 6 months
- •Pregnancy or breastfeeding
研究组 & 干预措施
Lithium arm
干预措施: Lithium (Drug)
non-Lithium arm
结局指标
主要结局
Relapse Rate
时间窗: Start of Maintenance Phase with repeated assessments at fixed points for six months (1 month, 2 month, 3 month, 4 month, 5 month, and 6 month) during the maintenance period through 6-month follow-up.
The investigators will compare the lithium-arm with the arm without lithium, as we look at the relapse rate and depression severity. Relapse rate was described as the percentage of patients in each of the two treatment arms that relapsed. Depression severity was measured using the Inventory of Depressive Symptomatology - Clinician Rated (IDS-C), a 30-item clinician-rated scale assessing the severity of depressive symptoms. Because only one of two 'appetite disturbance/body weight disturbance' items are selected for rating, the score of 28 items is added to reach a final score. Each item is scored 0-3, resulting in a total score range of 0-84, where higher scores indicate more severe depression.
次要结局
- Depression Severity Differences(Five monthly assessments at 2, 3, 4, 5, and 6 months during the Maintenance Phase (modeled as one value).)
- Cognitive Performance(Start of Maintenance Phase, timepoint at month 1.)
研究者
Didier Schrijvers
MD PhD
Universiteit Antwerpen