Continuation Electroconvulsive Therapy Associated With Pharmacotherapy Versus Pharmacotherapy Alone for Relapse Prevention in Major Depression. A Clinical, Controlled, Prospective and Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 104
- 试验地点
- 3
- 主要终点
- Hamilton Depression Rating Scale 21 items (HDRS-21)
研究概览
简要总结
OBJECTIVES:
To evaluate the comparative efficacy and security of Continuation Electroconvulsive Therapy associated with pharmacotherapy versus pharmacotherapy alone in the prevention of depressive relapse.
METHODS:
Demographic and clinical variables will be collected and side effects scales and neurocognitive battery will be performed. Variables of efficacy: relapse percentage in both groups in one year (primary variable); time without relapse. Main variable of security: occurrence of side effects and neurocognitive performance.
DESIGN: Randomized controlled clinical trial.
SAMPLE:
104 outpatients diagnosed with unipolar depression (DSM-IV-R criteria) who had remitted with a course of bilateral ECT. They will be randomized to two groups of treatment.
SETTING: Psychiatry Department at Bellvitge University Hospital.
ANALYSIS: Descriptive analysis of clinical variables; survive analysis and Cox model of regression.
详细描述
Major Depressive Disorder (MDD) is a severe psychiatric disorder that affects more than 6 million people in our country and has a life prevalence of 8.9% for men and 16. 5% for women (Haro et al, 2007). Besides, in recent decades, its incidence is increasing (Kessler et al, 2004). MDD has high recurrence rates and 25% of the cases develop chronification. Moreover it can occur at any age leading to severe disability. The majority of studies published in this field demonstrated the efficacy of antidepressant treatment in a short or medium-term basis, but there is a lack of long-term clinical trials regarding antidepressant efficacy and published ones present methodological problems. At present, a line of fundamental research in therapeutics includes pragmatic studies because they can answer crucial and specific questions in clinical practice. Therefore, the aim of this project is to conduct a pragmatic, parallel, randomized trial with 2 treatment arms to answer a key question of great interest to psychiatrists: Is it more effective to extend the use of ECT as maintenance therapy (together with drug therapy) rather than just using drug therapy in patients that previously required an acute ECT course for a depressive episode? This study is a controlled randomized clinical trial that starts after the remission of the acute depressive episode. Once patients have clinically remitted they will be randomized in two groups:
- C-ECT together with pharmacotherapy (same treatment used in the acute episode).
- Maintenance pharmacotherapy treatment (same treatment used in the acute episode).
Consolidation treatment with ECT will be considered finished after 9 months of being started, at which time patients will stay only on the pharmacological treatment they already had. The study will be completed within 15 months of patient inclusion (six months after the end of C-ECT). Patient assessment and follow-up will be conducted by participant researchers. Blind rater will conduct clinical and adverse effects ratings. A neuropsychologist will conduct neuropsychological assessments.
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
- Single (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
- •MDD diagnosis by DSM IV-TR.
- •ECT requirement during acute episode. Therapeutic indication will be based on clinical criteria, following APA guidelines. During the acute episode, patients will be controlled by the usual clinical care team.
- •Complete clinical remission (HDRS < or = 7 across two weeks).
- •Appropriate intellectual level that allows adequate communication.
- •Women of childbearing potential must use contraceptive methods.
- •Signed Consent form.
- •Other axis I or II diagnosis by DSM-IV-TR, except for nicotine dependence.
- •To be in maintenance ECT program.
- •To receive ECT during the previous three months of the acute episode.
- •Pregnancy or breastfeeding.
排除标准
- •Other axis I or II diagnosis by DSM-IV-TR, except for nicotine dependence.
- •To be in maintenance ECT program.
- •To receive ECT during the previous three months of the acute episode.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
C-ECT and Pharmacotherapy
Consolidation treatment with ECT will be considered finished after 9 months of being started, at which time patients will stay only on the pharmacological treatment they already had. The study will be completed within 15 months of patient inclusion (six months after the end of C-ECT). Patient assessment and follow-up will be conducted by participant researchers. Blind rater will conduct clinical and adverse effects ratings. A neuropsychologist will conduct neuropsychological assessments.
干预措施: C-ECT (Device)
Pharmacotherapy
Pharmacotherapy will remain unchanged since the acute episode to the end of the study. Psychotropics will be obtained as usually from the National Health System and will be prescribed according to data sheet.
干预措施: PHARMACOTHERAPY (Drug)
结局指标
主要结局
Hamilton Depression Rating Scale 21 items (HDRS-21)
时间窗: One year. HDRS will be assessed in each follow-up visit (weekly the first month, fortnightly the second and third month, monthly the following 6 months and quarterly at 12 and 15 months).
HDRS-21 will measure the relapse year in each group. Relapse will be defined as the reappearance of relevant symptoms after resolutin of the acute episode, measured by a scoring in HDRS-21 between 15-17 over two following measures or a HDRS\>18 score in a single measure.
次要结局
- Trail Making Test A(Basal, at 8 months and 12 months)
- Trail Making Test B(Basal, at 8 months and 12 months)
- UKU - Adverse effects rating scales(Every assessment (weekly, fortnightly, monthly and quarterly) till the month 15 of the follow-up.)
- Demographical Data Memory (MEDABI-20)(Basal, at 8 months and 12 months)
- Rey Figure(Basal, at 8 months and 12 months)
- Stroop Test(Basal, at 8 months and 12 months)
- Direct and inverse digits (WAIS, Weschler Adults Intelligence Sacle).(Basal)
- Mini-Mental State Examination (MMSE 35)(Basal, at 8 months and 12 months)
- Vocabulary WAIS (Weschler Adults Intelligence Scale)(Basal)
- Hospital Day Quotient (HDQ)(One year)
- Frequency Hospitalization Quotient(One year)
研究者
Mikel Urretavizcaya Sarachaga
Psychiatrist, MD, PhD
Hospital Universitari de Bellvitge