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临床试验/NCT03584945
NCT03584945已完成不适用

Task Control Circuit Targets for Obsessive Compulsive Behaviors in Children

University of Michigan3 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2019年3月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
169
试验地点
3
主要终点
Blood oxygen-level dependent (BOLD) functional MRI signal during a cognitive conflict task

研究概览

简要总结

This study will use magnetic resonance imaging (MRI) to assess the function and structure of overlapping task control circuits in children with a range of Obsessive-Compulsive symptoms (OCS). The functioning of task control circuits will be assessed using the well-validated Multisource interference task (MSIT). This study will also assess functional and anatomical connectivity within task control circuits in the same children, and determine whether disturbances in these overlapping circuits are associated with Obsessive-Compulsive Disorder (OCD) symptom severity. Behavioral measures will be administered to further assess regulatory, learning and memory functions. Children with OCD will then be offered a standard course of up to 12 cognitive behavioral therapy (CBT), either via remote video conference sessions or in person visits when clinically indicated, before scanning (along with age-and gender-matched control participants) in order to assess how these circuits may change with treatment. Children with subclinical OC symptoms will be offered referral for treatment on an as-needed basis. In addition, de-identified data may be used in the future to conduct secondary data analyses. As more about OC symptoms and neurobiological mechanisms of interest in the current study are understood, data may be used to answer questions beyond those described in this protocol. All study procedures will be conducted on-site at Columbia University/the New York State Psychiatric Institute (New York, NY) and the University of Michigan's outpatient Child and Adolescent Psychiatry (Ann Arbor, Michigan).

详细描述

Recruitment is complete. U.S. Department of Health and Human Services OHRP issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023. This study will resume analysis of results from its two sites for results reporting after OHRP and the IRB has approved the resumption of research.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Blood oxygen-level dependent (BOLD) functional MRI signal during a cognitive conflict task

时间窗: up to 16 weeks after baseline (following 12 weeks of therapy for intervention groups); approximately 15-20 minutes

次要结局

  • Obsessive Compulsive Inventory - Child Version (OCI-CV)(baseline assessment of all participants (OCD, subclinical OCS and HC))
  • Blood oxygen-level dependent (BOLD) functional connectivity MRI of task control circuits(up to 16 weeks after baseline (following 12 weeks of therapy for intervention groups);approximately 10 minutes)
  • Child Yale-Brown Obsessive Compulsive Scale(up to 16 weeks after baseline (following 12 weeks of therapy for intervention groups);approximately 1 hour)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kate D. Fitzgerald

Professor

Columbia University

研究点 (3)

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