Neuromodulation for Comorbid Hoarding Disorder and Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Hamilton Rating Scale for Depression
研究概览
简要总结
The primary goal of this study is to evaluate whether intermittent theta burst stimulation (iTBS) is effective for treating depression in people who have depression and chronic hoarding disorder (HD). The study will also evaluate whether this treatment can improve HD symptoms, cognitive performance, and brain region connectivity. The study team will investigate how the treatment works for depression, as well as other factors that can enhance or hinder treatment, such as pre-treatment level of depression, cognitive performance, or brain region connectivity.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male, female, or non-gender conforming individuals (i.e. those who do not identify as male or female)
- •All racial and ethnic groups
- •Ages 18 to 70
- •Meets criteria for current Major Depressive Episode within the context of Major Depressive Disorder, per HAM-D and DIAMOND.
- •Meets criteria for current Hoarding Disorder, per SIHD
- •Score of 18 or higher on the HAMD-17, indicating moderate to severe depressive symptoms
- •Stable on psychiatric medications for 6 weeks, with no changes to psychiatric medications expected during the study period
- •No contraindications to TMS (passes the TMS Adult Safety Screening questionnaire)
- •No contraindications to MRI (passes MRI safety screening questionnaire)
- •Able to commit to the treatment schedule
- •Able to complete assessment procedures in English
- •Intact decision-making capacity and ability to provide voluntary informed consent
排除标准
- •History of other neurological condition including but not limited to: conditions associated with increased intracranial pressure; space occupying brain lesions; cerebral aneurysm; stroke; transient ischemic attack within past two years; Parkinson's disease; Huntington's disease; dementia; multiple sclerosis; history of brain surgery; epilepsy; seizure except those therapeutically induced by electroconvulsive therapy (ECT) or a febrile seizure of infancy
- •Implanted medical devices that are not explicitly recognized as MRI safe, including cardiac pacemaker, medication pump, aneurysm clip, shunt, stimulator, cochlear implant, electrodes, or any other metal object within or near the head (excluding the mouth) that cannot be safely removed
- •Active manic or psychotic illness per DIAMOND
- •Current substance use disorder per DIAMOND
- •Current active suicidal or spontaneously disclosed homicidal ideation. Active suicidal ideation for this study is defined as a score of 3 or greater on the HAMD-17 and/or 3 or more on the PHQ-
- •Pregnant or intending to become pregnant within the study period; breastfeeding
- •Other sensory conditions or illnesses precluding participation in assessments or treatment
- •Current dose of lorazepam 2 mg or greater daily (or benzodiazepine equivalent) or any anticonvulsant due to the potential to limit iTBS efficacy
- •Taking medication that lowers seizure threshold
- •Previous failed treatment with rTMS, iTBS, or ECT
研究组 & 干预措施
iTBS
intermittent Theta Burst Stimulation (a form of transcranial magnetic stimulation) targeting the left dorsolateral prefrontal cortex
干预措施: iTBS (Device)
结局指标
主要结局
Hamilton Rating Scale for Depression
时间窗: change from baseline to 8 weeks
Hamilton Rating Scale for Depression, measuring depression symptom severity. Min=0, Max=50. Higher scores represent more severe depression symptoms.
Saving Inventory -- Revised
时间窗: change from baseline to 8 weeks
Saving Inventory - Revised, measuring hoarding symptom severity. Min=0, Max=92. Higher scores indicate more severe hoarding symptoms.
次要结局
- Hoarding Rating Scale(change from baseline to 8 weeks)
- Patient Health Questionnaire - 9(change from baseline to 8 weeks)
- Neuropsychological Global Deficit Score(change from baseline to 8 weeks)
- Resting State Functional Connectivity(change from baseline to 4 weeks)
研究者
Elizabeth Twamley
Professor of Psychiatry
University of California, San Diego