rTMS in Treatment Resistant Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Depression Severity as Assessed by the Montgomery Åsberg Depression Rating Scale (MADRS) Score
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of rTMS as an alternative treatment to ECT. The study will also provide data for a power analysis to support a larger clinical trial if there is evidence of a clinically relevant treatment effect.
详细描述
rTMS as an alternative to ECT
Background Electroconvulsive therapy (ECT) is highly effective in the treatment of severe depression (UK ECT Review Group, 2003). During the past decade, transcranial magnetic stimulation has emerged as a new anti-depressant treatment (e.g. Berman et al, 2000). Some randomized trials suggest that repetitive transcranial magnetic stimulation (rTMS) might be as effective as ECT in the treatment of non-psychotic depression (Grunhaus et al, 2000, 2003; Janicak et al, 2002; Rosa et all, 2003; Pridmore et al, 2000; Pridmore, 2000 ). Even at 3 and 6 month follow up, patients treated with rTMS continue to do as well as those treated with ECT (Dannon et al, 2002). A recent review also supported the efficacy of rTMS in treatment resistant depression (Lee et al, 2012). However, other reviews and meta-analyses show only moderate enthusiasm for transcranial magnetic stimulation as an alternative to ECT (e.g. Martin et al, 2003; Schlaepfer et al, 2003) and emphasize the need for further studies.
Given the small number of side effects and comparable efficacy to ECT, we would like to continue investigating rTMS as an alternative to ECT. The study will aim to compare the efficacy of sham vs. active rTMS in patients meeting standard criteria for ECT. In addition, the study will also determine the safety and efficacy of this trial and provide data for a power analysis to support a larger clinical trial if there is evidence of a clinically relevant treatment effect.
Our sample population will include 40 adult patients from the Emory University Outpatient Psychiatry Department and Atlanta community. Potential subjects may be identified by their treating physicians as potential subjects for the study and after obtaining permission from the patient, the physician will refer the patient to the research coordinator.
Subjects will enter a 4-week fixed-treatment phase and a variable 2-week extension for clinical improvers (defined below). Subject will receive rTMS treatment according the FDA approved protocol with treatments given five times a week daily Monday through Friday at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
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
- Quadruple (Participant, Care Provider, 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
- •Diagnosis of unipolar major depressive disorder or bipolar disorder, depressed phase and on medication to prevent a manic episode
- •Pretreatment Montgomery Åsberg Depression Rating Scale (MADRS) score ≥ 20
- •Over age 18 years
- •Meeting criteria for ECT according to standards outlined in American Psychiatric Association Task Force on Electroconvulsive Therapy (2001) (American Psychiatric Association Task Force on Electroconvulsive Therapy: The Practice of Electroconvulsive Therapy: Recommendations for Treatment, Training and Privileging, Task Force Report on ECT, 2nd Edition. Washington, DC, American Psychiatric Association, 2001) and qualifying for ECT in the opinion of the study physician and the subject's psychiatric provider.
- •Subjects may be on psychotropic medications including antidepressants, antipsychotics, benzodiazepines and anticonvulsants but the dosage of the medication must be stable for at least 6 weeks
- •Able and willing to provide informed consent
排除标准
- •Be pregnant or lactating, planning to become pregnant within the next three months or sexually active and not using birth control.
- •Diagnosis with the following conditions (current unless otherwise stated):
- •Have a neurological disorder, including a history of seizures, cerebrovascular disease, primary or secondary tumors in central nervous system, stroke, cerebral aneurysm or movement disorder or any lifetime history of loss of consciousness due to head injury.
- •Any current Axis 1 psychotic disorder (including substance-induced psychosis, psychotic disorder due to a medical condition, or major depression with psychotic features), as defined by the MINI ( Mini International Neuropsychiatric Interview; English Version 7.0.0 for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); Copyright 1992---2014 Sheehan DV) at the screening visit;
- •Any lifetime Axis 1 psychotic disorder (excluding substance-induced psychosis, or psychotic disorder due to a medical condition), or as defined by the MINI at the screening visit;
- •Any current Axis II personality disorder that would interfere in the participation of the study as determined through medical history or in the opinion of the investigator;
- •Have a current amnestic disorder, dementia, or delirium as defined by Montreal Cognitive Assessment of less than or equal to 16;
- •Any illicit substance use as determined by positive toxicology screen for drugs of abuse; or alcohol and/or substance abuse or dependence within the past 3 months (90 days) as determined by the MINI at the screening visit
- •Treatment histories including:
- •Failure to clinically remit to an adequate trial of electroconvulsive therapy (ECT), defined as 8 bilateral or 10 unilateral treatments, in the current episode;
- •Have failed prior treatment with vagal nerve stimulation (VNS);
- •Prior treatment with TMS.
- •Have active suicidal intent or plan as defined by a positive answer to questions 4 and/or 5 on the Columbia-Suicide Severity Rating Scale (CSSRS): Screening version; or more than one suicide attempt in lifetime; or a suicide attempt in the past twelve months; or in the Investigator's opinion, is likely to attempt suicide within the next six months.
- •Participation in any drug or device clinical trial in the six weeks (42 days) prior to the screening visit and/or participation in another clinical trial for the duration of the study.
- •Presence of any other condition or circumstance that, in the opinion of the investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments
结局指标
主要结局
Depression Severity as Assessed by the Montgomery Åsberg Depression Rating Scale (MADRS) Score
时间窗: Baseline, Week 6
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. The MADRS-S instrument has nine questions, with an overall score ranging from 0 to 60 points. A higher score indicates greater depressive symptoms.
次要结局
- Quality of Life Assessed by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-Les-SF) Score(Baseline, Week 6)
研究者
William McDonald MD
Principal Investigator
Emory University