NCT06746857尚未招募不适用
iTBS-Neurosplasticity for Female Youth With Depression
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 8
- 主要终点
- Hamilton Rating Scale Depression
研究概览
简要总结
TBC
详细描述
TBs
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
- 16 Years 至 24 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •are assigned female sex at birth;
- •are 16yo to 24yo;
- •outpatients;
- •are competent to assent (those age 16-18) or consent to participate (those age 19-24);
- •have a Diagnostic and Statistical Manual of Mental Disorders Fifth edition (DSM 5) diagnosis of Major Depressive Episode by Mini-International Neuropsychiatric Interview (MINI) version 7.0.0 for participants aged 18-24 and Adolescents (MINI-KID) for participants aged 16-17;
- •have a score ≥ 18 on the Hamilton Depression Rating Scale (HDRS-17 item) or Depressive symptom severity as shown by a total Children's Depression Rating Scale Revised (CDRS-R) score 40;
- •have not changed dose or initiated a new regular antidepressant or antidepressant augmentation treatment(s) for 4 weeks prior to starting TMS treatment;
- •are able to adhere to the treatment schedule;
- •pass both the TMS and MRI adult safety screening questionnaires.
排除标准
- •have Moderate or Severe Substance Use Disorder (except tobacco) within the last three (3) months;
- •have a concomitant major unstable medical illness;
- •have active suicidal intent;
- •have not responded to 2 or more adequate trials of antidepressant medication in the current episode as meassured by the ATHF form
- •are pregnant or planning to become pregnant during the study period;
- •have a lifetime (MINI) diagnosis of any psychotic disorder;
- •have a MINI anxiety disorder or personality disorder assessed by a study investigator to be primary and causing greater impairment than MDE;
- •have previously had ECT or rTMS;
- •have any significant neurological disorder or any significant head trauma with clear radiological evidence of cerebrovascular injury on imaging.
- •have any intracranial implant (e.g., aneurysm clips) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
- •have history of epilepsy
- •are participating in standardized regular psychotherapy provided by a psychiatrist or a registered psychologist for less than 3 months prior to study entry or planning to start during the course of rTMS treatments;
- •have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators;
- •have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview);
研究组 & 干预措施
Accelerated iTBS
Experimental
干预措施: repetitive transcranial magnetic stimulation (Device)
结局指标
主要结局
Hamilton Rating Scale Depression
时间窗: Four weeks
Minimum score: 0; Maximum score: 52; higher scores mean worse outcome.
Hamilton Rating Scale Depression
时间窗: Four weeks
Minimum score: 0; Maximum score: 52; higher scores mean worse outcome.
次要结局
未报告次要终点
研究者
Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA
Associate Professor
University of British Columbia
相似试验
Unknown
不适用
Mentalization - Based Treatment: Adolescents With Co-morbid Depression and Personality DisorderDepressionPersonality DisorderNCT01204346North East London Foundation Trust75
已完成
不适用
Treatment, Emotion, and Neuromodulation of Depression (TREND) StudyDepressionNCT05436379Erika Forbes21
终止
不适用
Pilot Study Using Transcranial Electrostimulation (TESA-HB) Therapy for the Treatment of Depressive SymptomsMild to Moderate DepressionNCT03471754Annecto LLC12
已完成
不适用
Transcranial Direct Current Stimulation (tDCS) in Young Individuals with Major Depressive Disorder: a Literature Review and Feasibility StudyMajor Depressive DisorderNCT06518642The University of Hong Kong8
已完成
不适用
Treatment of Depressed Adolescents With Physical IllnessDepressionInflammatory Bowel DiseaseNCT00446238University of Pittsburgh41