CTRI/2018/10/016219尚未招募2 期
Use of Theta burst stimulation in adolescents with depression: Evaluating acceptability, safety, tolerability, and efficacy.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To measure Adverse effect of TMS using structured tool devised by Pascal Leone , Visual analogue scale , Neuropsychological tests and rate of discontinuation
研究概览
简要总结
Primary purpose
-
To study safety , tolerability and acceptance of TBS in adolescents with depression
-
To measure the efficacy of TMS as an add on to standard of care in adolescents with depression.
Hypothesis
-
TMS will be well tolerated by adolescents with minimal to none adverse effects and accepted by adolescents and their families
-
TMS will reduce severity of depression .
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 12.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •12-18 years of age, either gender
- •Moderate – Severe Depression (as per DSM 5)
- •In patients in department of child & adolescent psychiatry,NIMHANS
- •Parents willing to consent for the study.
排除标准
- •Intracranial implants (cochlear implants, aneurysmal clips)
- •Acute emergencies like high suicidal risk and catatonia where ECT is considered as a first line treatment
- •Current/Past history / family history of epilepsy
- •Adolescents on Methylphenidate , Bupropion , Clozapine, Tricyclic antidepressants
- •Active Neurological illness / head injury
- •Autism spectrum disorder , Intellectual developmental disorder
- •Organic mood disorders
- •Chronic physical illness.
结局指标
主要结局
To measure Adverse effect of TMS using structured tool devised by Pascal Leone , Visual analogue scale , Neuropsychological tests and rate of discontinuation
时间窗: baseline , daily after TMS sessions , 1 week , 2 week , 3 month
次要结局
- acceptability of TBS as a treatment modality as measured by ratio of those who accept TMS as treatment modality to those who were offered same(2 weeks)
- efficacy in terms of change in severity of depression over period of 12 weeks as measured by fall in CDRS-R scores(Baseline , 2 weeks , 3 months)
研究者
研究点 (1)
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