Efficacy of Accelerated Theta Burst Stimulation for Treatment of Suicidality in Patients With Unipolar and Bipolar Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 2
- 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 investigate efficacy of accelerated theta burst stimulation (TBS) in suicidal reduction in patients with unipolar and bipolar depression
详细描述
Introduction:
Depression is the leading cause of disability worldwide and is associated with increased suicide risk, morbidity and mortality.(Sousa et al .,2022).
In severe cases, depression can result in suicide and approximately 800,000 suicides occur each year (Lepine et al.,2011). Rates of completed suicide are also high, varying from 10 to 19% (Goodwin et al., 1990). Lifetime rates of attempted suicide in bipolar depression range (26-29%) and (14-16%) in unipolar depression disorder (Chen et al., 1996).
The general recommendation to reduce suicide risk is the effective treatment of the underlying depressive disorder, with medications and psychosocial interventions (Jacobs et al., 2010). However, there exist several difficulties. Neither antidepressants nor psychotherapy work fast enough for reduction of suicidal ideation.
Beside pharmacotherapy and psychotherapy brain stimulation methods have gained increasing relevance in the treatment of depression during the last decades (Baeken et al.,2019).
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 MDD or bipolar (I or II) disorder and confirmed by Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID-I). (First & Gibbon.,2004 ).
- •Meeting the severe depression cutoff for MADRS (>/=35) at baseline visit.
- •Meeting the severe depression cutoff for BDI-II (>/=30) at baseline visit.
- •Presence of suicidal ideation and/or behavior (confirmed with Columbia Scale for the Rating of Suicide Severity (C-SSRS)
- •Adults (Age 19 years or older )
- •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.
- •Pass the TMS adult safety screening (TASS) questionnaire
- •Exclusion Criteria
- •Current substance use disorder during the past 3 months
- •Current psychotic disorder or symptoms
- •Presence of dementia
- •Presence of major medical illness, for example metastatic cancer, end stage renal disease
- •Inability to verify contact information.
- •Presence 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)
- •Presence of hypomanic symptoms (score on Young Mania Rating Scale (YMRS) greater than 12)
- •Current severe insomnia (must sleep a minimum of 5 hours the night before stimulation)
- •Using lorazepam greater than 2 mg daily (or equivalent) due to the potential to limit rTMS efficacy
排除标准
- 未提供
研究组 & 干预措施
Unipolar depressed patients with suicidality
The participants 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 120% 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)
Bipolar depressed patients with suicidality
The participants 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 120% 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)
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 , 6 month, 9 month and 12 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 , 6 month ,9 months and 12 month)
研究者
Medhat Bassiony
Professor of Psychiatry
Zagazig University