Treatment, Emotion, and Neuromodulation of Depression (TREND) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- depression severity
研究概览
简要总结
The investigators will administer theta burst stimulation (TBS) in efforts to observe a decrease in severity of reported depression symptoms. A subset of participants will receive positive affect training during this intervention.
详细描述
The study has a longitudinal design in which participants complete a baseline assessment, 20 or 30 theta burst stimulation (TBS) sessions, a post-TBS assessment, and a follow-up assessment 4 months later. Ideally, TBS sessions will be delivered two or three times a day, 5 days/week, for 2 weeks. This procedural design of a shorter treatment duration is based on findings of pattern of improvement and newly developed SAINT protocol. A subset of participants will receive training in enhancing positive affect, with 10 training sessions occurring between pairs of TBS sessions. In this study, "response" to intervention will be defined as a greater than 50% decrease in severity of depression symptoms reported by participants.
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 26 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current Diagnostic and Statistical Manual (DSM-5) Depressive Disorder
排除标准
- •Bipolar disorder (lifetime)
- •Obsessive-compulsive disorder (lifetime)
- •History of psychosis
- •Daily use of nicotine
- •Past-month use of cocaine, amphetamines, Methyl enedioxy methamphetamine (MDMA), Phencyclidine (PCP), Ketamine, or gamma-hydroxybutyrate (GHB)
- •Past 6 month substance use disorder
- •Binge drinking (using NIAAA criteria) within the past week, alcohol use in the past 12 hours
- •Neurological disorders: Epilepsy, Parkinson's Disease, brain tumor, brain injury, stroke
- •History of head trauma with a loss of consciousness (e.g., concussion)
- •History of seizures
- •MRI contraindications: body shape/size too large to fit in scanner, claustrophobia, and ferromagnetic metal in the body
- •Pregnancy
- •Current use of Clozapine, Bupropion, or prescription stimulants
- •Current use of benzodiazepines or mood stabilizers
- •Body shape/size too large to fit in MRI scanner
- •Claustrophobia
- •Metal in the head or ferromagnetic metal in the rest of the body
- •Implanted medical devices
- •High-risk suicidality
研究组 & 干预措施
TBS
In this open-label trial, all participants will undergo 2 or 3 continuous TBS (cTBS) sessions per visit over 10 days (weekdays, over 2 weeks; total = 20 or 30 TBS sessions in 10 visits). The total time of each pair of sessions (including pause between sessions) will be approximately 1 hour, with each session lasting approximately 100 seconds.
There is only 1 group and 1 arm of the study. All participants will receive the treatment.
干预措施: Theta Burst Stimulation (Device)
结局指标
主要结局
depression severity
时间窗: up to 1 year
Score on the Montgomery-Asberg Depression Rating Scale (MADRS), administered by a study team member
次要结局
未报告次要终点
研究者
Erika Forbes
Professor
University of Pittsburgh