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Task Control Circuit Targets for Obsessive Compulsive Behaviors in Children

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ClinicalTrials.gov Identifier: NCT03584945
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : May 13, 2019
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
Kate D. Fitzgerald, University of Michigan

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 cognitive behavioral therapy (CBT) before rescanning (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).

Condition or disease Intervention/treatment Phase
Obsessive-compulsive Disorders and Symptoms in Children Behavioral: Cognitive Behavioral Therapy Other: Community Referral as appropriate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Children ages 7-12 with OCD, obsessive compulsive symptoms, or healthy controls
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Task Control Circuit Targets for Obsessive Compulsive Behaviors in Children
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Obsessive Compulsive Disorder Behavioral: Cognitive Behavioral Therapy
The treatment team will offer a course of cognitive behavioral therapy (CBT) (45 minute sessions for 12 to 16 weeks), augmented by medication treatment when clinically indicated based on the clinical treatment standards. Cognitive-behavioral therapy (CBT) is a treatment based on learning and cognitive theories. CBT for Obsessive-Compulsive Disorder (OCD) involves gradually exposing patients to anxiety provoking stimuli while having patients refrain from engaging in compulsive rituals and/or avoidance behaviors. There are three major components of CBT treatment for OCD, specifically: (1) exposure to anxiety provoking stimuli, (2) response prevention, and (3) cognitive techniques intended to decrease anxiety during the exposure and response prevention processes.

Subclinical Obsessive-Compulsive symptoms (OCS) Other: Community Referral as appropriate
Participants with Obsessive Compulsive Symptoms will be referred to the community for treatment

No Intervention: Healthy Control



Primary Outcome Measures :
  1. Blood oxygen-level dependent (BOLD) functional MRI signal during a cognitive conflict task [ Time Frame: approximately 15-20 minutes ]
  2. Child Yale-Brown Obsessive Compulsive Scale [ Time Frame: approximately 1 hour ]
    Child Yale-Brown Obsessive Compulsive Scale (CYBOCS) is scored on a scale of 0 to 40, with 40 being the most severe.


Secondary Outcome Measures :
  1. Blood oxygen-level dependent (BOLD) functional connectivity MRI of task control circuits [ Time Frame: approximately 10 minutes ]
  2. Diffusion tensor imaging (fractional anisotropy, FA) in task control circuit regions [ Time Frame: approximately 10 minutes ]


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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Obsessive-Compulsive Disorder (OCD) patient group

INCLUSION:

  1. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) Diagnosis of OCD as the principal problem
  2. Not on psychotropic medication and not receiving current psychotherapy for OCD
  3. Written informed assent by the participants and consent by the parent
  4. Participants and a parent/guardian must be able to read and understand English

EXCLUSION

  1. DSM-V current diagnosis of major depressive disorder, attention-deficit hyperactivity disorder, or substance/alcohol abuse
  2. DSM-V lifetime diagnosis of psychotic disorder, bipolar disorder, eating disorder, pervasive developmental disorder, or substance/alcohol abuse
  3. Active suicidal ideation
  4. Females who are pregnant or nursing
  5. Major medical or neurological problems
  6. Presence of metallic device or dental braces
  7. Intelligence Quotient (IQ)<80
  8. A current or past diagnosis of pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS)
  9. Individuals who are currently receiving CBT, other forms of psychotherapy, or psychotropic medications
  10. Individuals who have received a full course of CBT in the past
  11. A positive pregnancy test
  12. Positive urine screen for illicit drugs

Healthy controls

INCLUSION:

  1. Written informed assent by the participants and consent by the parent
  2. Participants and a parent/guardian must be able to read and understand English

EXCLUSION:

  1. Any current or lifetime psychiatric diagnosis
  2. Active suicidal ideation
  3. Females who are pregnant or nursing
  4. Major medical or neurological problems
  5. Presence of metallic device or dental braces
  6. IQ <80
  7. A current or past diagnosis of pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS)
  8. A positive pregnancy test
  9. Positive urine screen for illicit drugs

Obsessive Compulsive Symptoms

INCLUSION:

  1. Presence of obsession(s) and/or compulsion(s) but no current or past history of OCD
  2. Not on psychotropic medication and not receiving current psychotherapy for OCD
  3. Written informed assent by the participants and consent by the parent
  4. Participants and a parent/guardian must be able to read and understand English

EXCLUSION:

  1. DSM-V current diagnosis of major depressive disorder, attention-deficit hyperactivity disorder, Tourette's/Tic Disorder, or substance/alcohol abuse
  2. DSM-V lifetime diagnosis of psychotic disorder, bipolar disorder, eating disorder, pervasive developmental disorder, or substance/alcohol abuse
  3. Active suicidal ideation
  4. Females who are pregnant or nursing
  5. Major medical or neurological problems
  6. Presence of metallic device or dental braces
  7. IQ<80
  8. A current or past diagnosis of pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS)
  9. Individuals who are currently receiving CBT, other forms of psychotherapy, or psychotropic medications
  10. Individuals who have received a full course of CBT in the past
  11. Positive urine screen for illicit drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584945


Contacts
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Contact: Jennifer Nidetz, MSW 734-232-0293 jkgreene@med.umich.edu
Contact: Lana Khamash, BA 646-774-5868 lana.khamash@nyspi.columbia.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Ashley Synger, MA    734-232-0382    syngera@med.umich.edu   
Contact: Laura Stchur, MSW    734-236-1323    lmarine@med.umich.edu   
Principal Investigator: Kate Fitzgerald, MD         
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Lana Khamash, BA    646-774-5868    lana.khamash@nyspi.columbia.edu   
Contact: Martine Fontaine, BS    646-774-6072    martine.fontaine@nyspi.columbia.edu   
Principal Investigator: Rachel Marsh, PhD         
Sponsors and Collaborators
University of Michigan
Columbia University

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Responsible Party: Kate D. Fitzgerald, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03584945     History of Changes
Other Study ID Numbers: HUM00144074
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participant data will be shared between sites at the University of Michigan and Columbia. A DUA will also be established per University guidelines as required. Coded, de-identified IPD will be shared with the NIMH data repository, RDoCdb.
Supporting Materials: Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Compulsive Behavior
Personality Disorders
Mental Disorders
Anxiety Disorders
Impulsive Behavior