Sham-Controlled rTMS for Refractory Depression in Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- 17-item Hamilton Rating Scale for Depression (HDRS)
研究概览
简要总结
Evaluate the efficacy of accelerated theta burst stimulation (aTBS) in reducing depressive symptoms in autism spectrum disorder (ASD)
详细描述
The overall goal of this study is to treat major depressive disorder (MDD) rapidly and effectively in individuals with autism spectrum disorder (ASD). Our central hypothesis is that accelerated theta burst stimulation (aTBS) targeting the left dorsal lateral prefrontal cortex (DLPFC) will significantly improve MDD symptoms and rate of remission compared to sham. We propose a double-blind RCT of 13-to 26-year-old individuals with ASD with MDD to test the efficacy of aTBS (n=12) versus sham (n=12) treatment. Participants will be rigorously characterized, including co-occurring conditions, any concurrent therapies, medications, social function, cognition, and sensory profile. A core battery of assessments will assess the efficacy of the intervention and maintenance of gains with respect to MDD and ASD-specific symptomology. Neural target engagement will be assessed by source-localized Electroencephalography (EEG) connectivity.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 13 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fluent in English and able to volunteer in the informed consent process and provide spontaneous narrative description of key elements, risks, and benefits of the study.
- •Aged 13-26, inclusive.
- •Full-scale intelligence quotient ≥
- •Diagnosis of ASD using criteria from Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). Diagnosis will be confirmed by study psychologist/social worker and supported by scoring in the ASD on the Autism Diagnostic Observation Schedule (ADOS-2).
- •Diagnosis of MDD based on psychologist diagnosis and DSM-5-based structural diagnostic interview determine via KSADS
- •Exhibiting treatment resistance to at least one antidepressant drug treatment of adequate dose and duration.
- •Symptoms of moderate to severe depression according to Hamilton Depression Rating Scale ≥ 20 which must be maintained through lead-in period.
- •Participants are not required to discontinue current interventions but must agree to attempt to keep medications and other interventions stable during the study.
排除标准
- •Participation in an investigational drug trial within the past three months.
- •Active substance use disorder (excluding tobacco use) within the past 6 months.
- •Contraindications to Transcranial Magnetic Stimulation including, but not limited to, a history of epilepsy, the presence of metallic foreign bodies, or implanted medical devices (e.g. pacemaker, medical pump).
- •Actively suicidal (i.e., suicidal ideation with plan and intent) or deemed at high risk for suicide.
- •Current use of anticonvulsant, barbiturate, lithium, or benzodiazepine medications.
- •Prior rTMS treatment.
- •For female subjects of childbearing potential, a positive urine pregnancy test.
研究组 & 干预措施
Sham controlled
Sham aTBS targeting the left dorsolateral prefrontal cortex, 5 sessions per day for 5 days. If participants in the sham group do not show a significant treatment response by the 12-week follow-up - defined as a 50% reduction from baseline on the HDRS- they will then become eligible for and offered active, open-label treatment.
干预措施: Transcranial Magnetic Stimulation Sham (Procedure)
Active TBS Treatment
Active aTBS targeting the left dorsolateral prefrontal cortex, 5 sessions per day for 5 days.
干预措施: Transcranial Magnetic Stimulation (Procedure)
结局指标
主要结局
17-item Hamilton Rating Scale for Depression (HDRS)
时间窗: Completed at Screening, baseline, 2-week, 6-week, and 12-week follow up
The HDRS is a 17-item rating scale administered by a trained rater following a semi-structured interview. Scores of 0-7 are generally within the normal range, and a score of 20 or higher indicates moderate depression severity. Research suggests that a decrement of 7 points on the HAMD-17 represents minimally clinically important differences from patient perspectives. HDRS will be assessed at screening, baseline and all follow up visits.
NIH Toolbox Cognition Battery
时间窗: Completed at Screening, 2-week, 6-week, and 12-week follow up
The NIH Toolbox was designed to serve as a brief, convenient set of measures to supplement other outcome measures in epidemiologic and longitudinal research and clinical trials.
次要结局
- Electroencephalography (EEG)(Completed at baseline, 2-week, 6-week, and 12-week follow up)
研究者
Rana Elmaghraby
MD
Children's Hospital Medical Center, Cincinnati