Efficacy of Unilateral Versus Bilateral Accelerated Theta Burst Stimulation in Treatment of Patients With Bipolar Depression and Suicidality
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change in suicidal ideation and behaviors as measured by Columbia Suicide Severity Rating Scale (C-SSRS)
研究概览
简要总结
The objective of this study is to compare the efficacy of left unilateral versus bilateral accelerated Theta Burst Stimulation (TBS) in suicidal reduction and in reduction of severity of depressive symptoms in patients with bipolar depression.
详细描述
Introduction:
Repetitive transcranial magnetic stimulation (rTMS) therapy is a noninvasive neurostimulation treatment that has been adopted as a first-line treatment for pharmacotherapy-resistant major depressive disorder (MDD) (Milev et al., 2016). rTMS induces electrical activity in the cortex using magnetic fields generated outside of the head. However, the evidence for antidepressant efficacy of rTMS in the treatment of bipolar depression is limited and derived primarily from small trials (Tavares et al., 2017, Dolberg et al., 2002, Nahas et al., 2003, Beyne et al., 2014, Tamas et al., 2007) and subsets of trials in major depression that included individuals with bipolar disorder (McGirr et al., 2016, Nguyen et al., 2021 ).
The proposed study will examine sequential bilateral versus Unilateral accelerated theta burst stimulation (aTBS) in treatment of patients with bipolar depression and suicidality.
Hypothesis:
We assume that bilateral accelerated TBS is superior than left unilateral accelerated TBS in treatment of suicidality while bilateral accelerated TBS is as effective as left unilateral accelerated TBS in treatment of depressive symptoms in bipolar patients.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Major depressive episode as a part of bipolar (I or II) disorder and confirmed by Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID-I)
- •Meet the threshold on the total MADRS score of >/=35 at baseline visit (severe)
- •Meet the threshold on the total BDI-II score of >/=30 at baseline visit (severe)
- •Ongoing suicidal ideation and/or behavior (confirmed with Columbia Scale for the Rating of Suicide Severity (C-SSRS) , score >/=3 (moderate to high risk)
- •Age 19 years or older (Adults, Older Adults)
- •Right handedness
- •Both genders
- •Able to provide informed consent to participate in the study
- •Participants were required to have been taking a stable pharmacological regimen for 2 weeks before screening that had to include a mood stabilizer (lithium >0.6 mEq/L or valproate >350 mM/L), an atypical antipsychotic, or a combination of a mood stabilizer and an atypical antipsychotic. For participants with BD type II, lamotrigine monotherapy was acceptable if the dose was greater than 100 mg daily
- •Pass the TMS adult safety screening (TASS) questionnaire
排除标准
- •No current substance abuse disorder for the past 3 months (previous substance abuse not exclusionary)
- •Any psychotic disorder or current active psychotic symptoms
- •No dementia or other major neurological disorders
- •No major medical illness, for example metastatic cancer, end stage renal disease
- •Not able to verify contact information. Participants must be able to follow through with the study & must have verified contact information and at least one verified contact
- •Pregnancy. While there are no known risks to a fetus this is a new use of TMS, which has not been tested, thus pregnancy is exclusionary
- •Any history of any clinically significant neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, previous neurosurgery, or personal history of head trauma that resulted in loss of consciousness for > 5 minutes and retrograde amnesia for > 30 minutes
- •Conductive, ferromagnetic or other magnetic sensitive metals that are implanted or are non-removable within 30 cm treatment coil (around the head)
- •Score on Young Mania Rating Scale (YMRS) greater than 12 (patients with mixed features have been shown not to respond well to TMS treatment)
- •Rapid cycling Bipolar illness (patients with > 4 mood episodes within the past year will be excluded, as they have a higher risk of switch to mania)
- •Non response to ECT in current episode.
- •Current severe insomnia (must sleep a minimum of 5 hours the night before stimulation)
- •Are currently (or in the last 4 weeks) taking lorazepam greater than 2 mg daily (or equivalent) due to the potential to limit rTMS efficacy
研究组 & 干预措施
Left unilateral aTBS
Participants who are randomly assigned to this group will receive iTBS (intermittent theta burst stimulation) to the left dorsolateral prefrontal cortex (LDLPFC) determined using Beam method for 1800 pulses with an intertreatment interval of fifty minutes. Stimulation was at 90% of resting motor threshold. Patients received ten sessions every day for five consecutive days for a total of fifty sessions (90,000 pulses).
干预措施: Transcranial Magnetic Stimulation MagPro R30 with the MCF-B70 figure-of-eight coil (MagVenture, Denmark) (Device)
Sequential bilateral aTBS
Participants who are randomly assigned to this group will receive ten sessions daily for five consecutive days for a total of fifty sessions. During each session continuous theta burst stimulation (cTBS) in which (1800 pulses) are delivered continuously over 120 seconds to the right dorsolateral prefrontal cortex (RDLPFC) is administered first, followed by iTBS in which 1800 pulses are delivered in 2 second bursts, repeated every 10 seconds for 570 seconds (1800 pulses) to the left dorsolateral prefrontal cortex (LDLPFC) with using beam method for target localization. Stimulation was at 90% of resting motor threshold.
干预措施: Transcranial Magnetic Stimulation MagPro R30 with the MCF-B70 figure-of-eight coil (MagVenture, Denmark) (Device)
结局指标
主要结局
Change in suicidal ideation and behaviors as measured by Columbia Suicide Severity Rating Scale (C-SSRS)
时间窗: Assessed at baseline (day 0) , post-inpatient treatment completion (day 5) , 1 month ,3 month and 6 month.
The SI severity scale is composed of five yes=no questions of increasingly severe suicidal thoughts: a wish to be dead (1), non-specific suicidal thoughts (2), suicidal thoughts with a method (3), suicidal intent without specific plan (4), and suicidal intent with specific plan (5). This scale was scored from 0 to 5 according to the most severe suicidal ideation endorsed. Higher scores mean worse outcome. Suicidal behaviors were assessed dichotomously (yes=no) and include actual suicide attempts, interrupted suicide attempts, aborted suicide attempts, other preparatory acts (e.g., collecting pills, writing suicide note), and non-suicidal self-injury (NSSI).
次要结局
- Change from baseline Montgomery-Åsberg Depression Rating Scale (MADRS) Score(Assessed at baseline (day 0) , post-inpatient treatment completion (day 5) , 1 month ,3 month and 6 month.)
研究者
Medhat Bassiony
Professor of Psychiatry
Zagazig University