ISRCTN12571777已完成未知
Misophonia: An imaging study on the neurobiology and the efficacy of cognitive behavioural therapy
Academic Medical Center0 个研究点目标入组 60 人开始时间: 2016年10月28日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
2019 fMRI substudy results in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6525165/ (added 16/07/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Patient inclusion criteria:
- •1. Meet the diagnostic criteria for misophonia, as proposed by Schröder and Denys
- •2. Male and female, aged above 18 years
- •3. Female patients of childbearing potential must have a negative pregnancy test and use reliable method of contraception
- •4. Written informed consent
- •5. Eligible for exposure therapy
- •Healthy control inclusion criteria:
- •1. Age between 18 and 65
- •2. Subjects have signed informed consent in accordance with the provisions of the pertinent excerpt from the Declaration of Helsinki (October, 2000) and Dutch legal regulation (Wet Medisch Wetenschappelijk Onderzoek met Mensen).
- •3. No current or past psychiatric disorders
- •For the fMRI study an additional criterion has been established:
- •Age between 18 and 65
排除标准
- •1. Presence of any of the following DSM IV conditions:
- •1.1. Major depression
- •1.2. Major anxiety disorder
- •1.3. Bipolar Disorder
- •1.4. Autism Spectrum Disorders
- •1.5. Schizophrenia or any other psychotic disorder
- •1.6. Substance related disorder during the past 6 months
- •1.7. Epilepsy or any structural CNS disorder of stroke within the last year
- •2. Evidence of clinically significant and unstable cardiovascular, gastrointestinal, pulmonary, renal, hepatic, endocrine or haematological disorders, glaucoma, myocardial infarction within the past year or micturition abnormalities
- •3. Currently taking benzodiazepines, antidepressants or stimulants
- •4. Patients at risk for suicide
- •5. Inability to speak Dutch or English
- •For the fMRI study four additional criteria have been established:
- •1. Ferrous objects in or around the body (e.g. braces, glasses, pacemaker, metal fragments)
- •2. Drug or alcohol abuse over a period of six months prior to the experiment
- •3. History of closed-head injury
- •4. Patients with claustrophobia
研究者
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