A Novel and Practical Accelerated Low-frequency Right-sided Stimulation Protocol as a Substitute for Patients With Bipolar Depression Needing Electroconvulsive Therapy During the COVID-19 Pandemic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24)
研究概览
简要总结
The current study aims to assess the feasibility, acceptance and clinical outcomes of a practical high-dose LFR protocol, including tapering treatments and symptom-based relapse prevention treatments, in patients with bipolar depression previously responsive to ECT and patients needing urgent treatment due to symptom severity during the COVID-19 pandemic.
详细描述
Treatment resistant bipolar depression is a leading cause of disability and socioeconomic burden of disease, and current treatment options all suffer from critical deficiencies of efficacy, capacity, or tolerability, especially given the current COVID-19 pandemic. rTMS and aLFR in particular has the potential to overcome many of these deficiencies, and is safe and well-tolerated. Taken together with the reported findings of other groups, aLFR may be feasible, tolerable, and capable of achieving comparable and potentially better remission rates than longer 20 to 30-day courses and it may also be beneficial to taper treatments and use symptom-based relapse prevention treatments in an aLFR protocol. Importantly, our pilot data in two patients previously responsive to ECT and data from the Cole et al. study suggest that accelerated rTMS may be a potential substitute for ECT as it may be possible to achieve remission in patients with severe depressive symptoms who would otherwise receive ECT. Furthermore, there is a burden of being able to provide care to as many people as possible based on severity of illness during the pandemic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Currently are experiencing a bipolar depressive episode (bipolar disorder type 1 or 2) based on the MINI with or without psychotic symptoms
- •Have previous response to ECT or high symptom severity warranting acute ECT in the opinion of one of the brain stimulation psychiatrists
- •Are over the age of 18
- •Pass the TMS adult safety screening (TASS) questionnaire
- •Are voluntary and competent to consent to treatment
排除标准
- •have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of substance dependence or abuse within the last 1 month
- •Currently experiencing a mixed or manic episode (YMRS >12)
- •have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
- •have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder
- •have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT or a febrile seizure of infancy or single seizure related to a known drug related event, cerebral aneurysm, significant head trauma with loss of consciousness for greater than 5 minutes
- •have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
- •currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
- •Lack of response to accelerated course of rTMS in the past
研究组 & 干预措施
Accelerated LFR
In the acute treatment phase, treatment will occur 8 times daily (50 min pause between treatments) on weekdays, until symptom remission is achieved (HRSD-24 score < to 10) or a maximum of 10 working days of daily treatment. In the tapering phase, treatments will be reduced to 2 treatment days per week for 2 weeks and then 1 treatment day per week for 2 weeks (4 weeks total). Patients that have responded to treatment will then enter the symptom-based relapse prevention phase including virtual check-in with study staff and a treatment schedule based on symptom level according to a modified relapse prevention algorithm that has been developed to prevent relapse after a successful course of ECT (known as the STABLE algorithm). The relapse prevention phase will last a maximum of 6 months.
干预措施: MagPro X100 Stimulator, B70 Fluid-Cooled Coil (Device)
结局指标
主要结局
Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24)
时间窗: Up to 10 days (From screening/baseline to end of the acute treatment)
Less than or equal to 10 This scale is used to quantify the severity of symptoms of depression Scale range: 0-76 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
次要结局
- Change in Hamilton Rating Scale for Depresion 24-it (HRSD-24)(Up to 10 days (From screening/baseline to end of the acute treatment))
- Change in Young Mania Rating Scale (YMRS)(Up to 10 days (From screening/baseline to end of the acute treatment))
- Remission on General Anxiety Disorder 7 item (GAD-7)(Up to 10 days (From screening/baseline to end of the acute treatment))
- Response on General Anxiety Disorder 7 item (GAD-7)(Up to 10 days (From screening/baseline to end of the acute treatment))
- Remission on Beck Depression Inventory (BDI-II)(Up to 10 days (From screening/baseline to end of the acute treatment))
- Response on Hamilton Rating Scale for Depresion 24-it (HRSD-24)(Up to 10 days (From screening/baseline to end of the acute treatment))
- Remission on Patient Health Questionnaire (PHQ-9)(Up to 10 days (From screening/baseline to end of the acute treatment))
- Response on Patient Health Questionnaire (PHQ-9)(Up to 10 days (From screening/baseline to end of the acute treatment))
- Change on Beck Depression Inventory (BDI-II)(Up to 10 days (From screening/baseline to end of the acute treatment))
- Remission on Beck Scale for Suicidal Ideation (SSI)(Up to 10 days (From screening/baseline to end of the acute treatment))
- Change in WHO Disability Assessment Schedule (WHODAS) Range 0-38(Up to 10 days (From screening/baseline to end of the acute treatment))
- Proportion of Patients Maintaining Response During Relapse Prevention(24 weeks (Tapering and Relapse prevention phase))
- Change in General Anxiety Disorder 7 item (GAD-7)(Up to 10 days (From screening/baseline to end of the acute treatment))
- Change in Patient Health Questionnaire (PHQ-9)(Up to 10 days (From screening/baseline to end of the acute treatment))
- Response on Beck Depression Inventory (BDI-II)(Up to 10 days (From screening/baseline to end of the acute treatment))
- Change on Beck Scale for Suicidal Ideation (SSI)(Up to 10 days (From screening/baseline to end of the acute treatment))
研究者
Daniel Blumberger
Medical Head and Co-Director, Temerty Centre for Therapeutic Brain Intervention
Centre for Addiction and Mental Health