Transitioning From Maintenance ECT to Maintenance TMS in Treatment Resistant Depression
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Change in Hamilton Depression Rating Scale (HDRS)
研究概览
简要总结
Electroconvulsive therapy (ECT) is one of the most efficacious treatments available for treatment-resistant depression (TRD). Although a maintenance ECT protocol exists, multiple barriers limit its use for long-term use. These barriers include procedure tolerability, cognitive side effects, financial burden, and unreliable social support to accompany patients for these treatments. On the other hand, a different modality of noninvasive neuromodulation called transcranial magnetic stimulation (TMS) can be performed in the outpatient setting and does not need anesthesia. The likelihood of cognitive adverse effects with TMS is much lower than with ECT. Our clinical question encompasses piloting a maintenance TMS regimen to maintain remission in treatment-resistant major depressive disorder.
This will be a patient-preference clinical trial, with patients offered the choice to initiate maintenance TMS versus maintenance ECT after their index ECT sessions for treatment-resistant depression. There will be no randomization or placebo involved in this study.
详细描述
The clinical question encompasses piloting a maintenance TMS regimen to maintain remission in treatment-resistant major depressive disorder.
Patients who choose maintenance TMS will initiate maintenance TMS sessions on day one of the study and continue any currently prescribed pharmacotherapy. Participants will initiate TMS treatment within 1 week of last index ECT treatment. Participants will then follow a schedule of weekly for 4 sessions, every other week for 4 sessions, and monthly for 3 sessions for a total of 11 sessions in 6 months. Investigators will use the TMS paradigm called intermittent theta burst stimulation (iTBS), which was used in the SNT trial(Cole et al., 2022; Cole et al., 2020). At conclusion of the 6 month TMS portion of the study clinical judgement will be used to determine if the patient will return to maintenance ECT treatment. RBANS for assessment of cognition will be completed at the beginning, after 6 months, and at the conclusion of the study as well in both the standard of care and TMS portions of the study.
Those who choose maintenance ECT will transition to maintenance ECT treatments in the hospital as prescribed by their treating inpatient psychiatrists. On initial visit consent will be obtained and baseline cognitive and behavioral scales assessed as follows: Antidepressant treatment history form (ATHF), alcohol use disorder identification test (AUDIT-C), Hamilton Depression Rating Scale (HDRS), Clinical Global Impression (CGI), quick inventory of depressive symptomology (QIDS), Brief Psychiatric Rating Scale (BPRS), Drug Abuse Screening Test (DAST-10), Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS), standardized assessment of personality abbreviated scale (SAPAS). Patients will then be asked to return at 6 month and 12 month intervals to repeat HDRS, QIDS, RBANS, and CGI scales.
Research data will be collected primarily through self assessment scales including Antidepressant treatment history form (ATHF), alcohol use disorder identification test (AUDIT-C), Hamilton Depression Rating Scale (HDRS), Clinical Global Impression (CGI), quick inventory of depressive symptomology (QIDS), Brief Psychiatric Rating Scale (BPRS), Drug Abuse Screening Test (DAST-10), Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS), standardized assessment of personality abbreviated scale (SAPAS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients treated for TRD who have achieved remission through an index series of ECT
- •Able to provide informed consent
- •Age between 18 and 65 years
- •Deemed appropriate for maintenance TMS by their psychiatrist
- •Right-handed
排除标准
- •History of seizures or a seizure disorder
- •Related neurological disorder, or any other medical condition that would preclude TMS treatment determined by the treatment team.
研究组 & 干预措施
TMS
Patients who have achieved remission of treatment resistant depression through an initial course of ECT (8 to 12 sessions) at the University of Kentucky will be identified by the ECT attending physician as a candidate for this study. They will receive TMS in this arm of study for maintenance treatment of their depression and monitored with depressive scales.
干预措施: Transmagnetic Stimulation (Device)
ECT
Patients who have achieved remission of treatment resistant depression through an initial course of ECT (8 to 12 sessions) at the University of Kentucky will be identified by the ECT attending physician as a candidate for this study. If they elect to continue with maintenance ECT treatments which is the current standard of care, their depressive symptoms and cognitive functioning will be monitored accordingly.
干预措施: Electroconvulsive Therapy (Device)
结局指标
主要结局
Change in Hamilton Depression Rating Scale (HDRS)
时间窗: Baseline and prior to each procedure for duration of study, up to six months
One of the most widely used clinician administered depression scales containing 17 items. Scores range from 0 to 54 with 0-7 being normal, 8-16 being mild depression, 17-23 moderate depression and 24 or greater being severe depression. Higher scores equate to more severe depressive symptoms.
次要结局
- Change in Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS)(Baseline on initial presentation, at 6 months, and at 12 months)
- Change in Quick Inventory of Depressive Symptomatology (QIDS)(Baseline and prior to each procedure for duration of study, up to six months)
研究者
Austin Messner
Senior Medical Resident
University of Kentucky