Phase 1 Study: Evaluation of Three Continuation Therapies After Acute Electroconvusive Therapy (ECT) Concerning Efficacy and Cognition in Severly Depressed Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Score on HAMD after 6 and 12 months
研究概览
简要总结
The purpose of this study is to evaluate three different continuation treatments after acute ECT concerning efficacy and impact on cognition in severly depressed patients.
详细描述
BACKGROUND While electroconvulsive therapy (ECT) in major depression is effective, high relapse rates and cognitive effects limit its long-term use. Continuation treatment after ECT with combinations of C-ECT or psychotherapy and medication may decrease relapse rates and cognitive side effects while changing cognitive psychological variables like dysfunctional attitudes in the long-term.
CENTRAL RESEARCH QUESTIONS
- Evaluation of the efficacy of three continuation treatments aimed at preventing relapses after acute ECT
- Examination of the cognitive side effects and the changes of cognitive psychological variables during acute and continuation treatment
METHODS In a prospective, randomized, controlled, long-term study we assign 60 depressed ECT responder either to antidepressant treatment alone, or C-ECT plus medication, or cognitive behavioral group therapy plus medication. Depressive symptoms and cognition were assessed before, during, immediately after acute ECT and two, four, six, and 12 months during continuation therapy.
HYPOTHESES It is hypothesized that the use of combination continuation therapies after effective ECT leads to lower HAMD scores and lower relapse rates than the standard treatment with antidepressants alone after 6 months. In addition, we assume that the CBT group will establish more functional macro-patterns than the somatic treatments in the long term and will have the lowest HAMD scores and relapse rates after 1 year. With regard to the cognitive side effects, the autobiographical memory is expected to be the only specific part of memory being affected negatively by ECT in the short and long term.
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)
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
- •Major depressive episode (unipolar)
- •Response to acute ECT (at least 50% reduction in HAMD)
- •Capacity to consent
- •Sufficient comprehension of the German language
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 3 months
- •Acute suicidality
- •Judiciary hospitalization
研究组 & 干预措施
1
Continuation-Medication with Antidepressants (after WBS Guidelines)
干预措施: TCAs, SSRIs, NARIs, SNRIs, Lithium (Drug)
2
Continuation-ECT with Antidepressants
干预措施: TCAs, SSRIs, NARIs, SNRIs, Lithium (Drug)
2
Continuation-ECT with Antidepressants
干预措施: Electroconvulsive therapy (Procedure)
3
Continuation-Psychotherapy (Cognitive Behavioral Group Psychotherapy including the "Situational Analysis" of CBASP)
干预措施: TCAs, SSRIs, NARIs, SNRIs, Lithium (Drug)
3
Continuation-Psychotherapy (Cognitive Behavioral Group Psychotherapy including the "Situational Analysis" of CBASP)
干预措施: Cognitive behavioral group therapy (Behavioral)
结局指标
主要结局
Score on HAMD after 6 and 12 months
时间窗: 6 and 12 months after enetering continuation phase
次要结局
- Relapse rate after 6 and 12 months(6 and 12 months after enetering continuation phase)
- Response and remission rates after 6 and 12 months(6 and 12 months after enetering continuation phase)
- Scores on MADRS, BDI, and CGI after 6 and 12 months(6 and 12 months after enetering continuation phase)
研究者
Eva-Lotta Brakemeier
Dr. rer. nat.
Charite University, Berlin, Germany