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Clinical Trials/NCT03584945
NCT03584945CompletedNot Applicable

Task Control Circuit Targets for Obsessive Compulsive Behaviors in Children

University of Michigan3 sites in 1 country169 target enrollmentStarted: March 24, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
169
Locations
3
Primary Endpoint
Blood oxygen-level dependent (BOLD) functional MRI signal during a cognitive conflict task

Study Overview

Brief Summary

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).

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
6 Years to 14 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kate D. Fitzgerald

Professor

Columbia University

Study Sites (3)

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