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Overlapping Neural Circuits in Pediatric OCD

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ClinicalTrials.gov Identifier: NCT02421315
Recruitment Status : Recruiting
First Posted : April 20, 2015
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to examine the brain functioning of children and adolescent with OCD before and after treatment with Exposure and Response Prevention (EXRP) therapy.

Condition or disease Intervention/treatment
Obsessive Compulsive Disorder Behavioral: Exposure & Response Prevention (EX/RP) and when indicated medication treatment

Detailed Description:
The capacity to coordinate thoughts and actions to execute goal-directed behaviors (cognitive control) and the capacity to anticipate, respond to, and learn from reward (reward processing) are key processes for human behavior. Dysfunction in these processes has been hypothesized to contribute to repetitive thoughts and behaviors in many disorders, including obsessive-compulsive disorder (OCD), Tourette Syndrome (TS), and eating disorders. The investigators will use multimodal imaging to investigate neural circuits that support cognitive control and reward processing, using pediatric OCD as a model system. The short-term goal is to clarify how circuit-based abnormalities contribute to repetitive thoughts/behaviors; these data will inform future trans-diagnostic studies. The long-term goal is to identify control and reward circuit-abnormalities as targets for new trans-diagnostic treatments.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Overlapping Neural Circuits Implicated in Pediatric OCD
Study Start Date : October 2014
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017
Arms and Interventions

Arm Intervention/treatment
Experimental: OCD
Participants will have a current diagnosis of OCD.
Behavioral: Exposure & Response Prevention (EX/RP) and when indicated medication treatment
Cognitive Behavioral Therapy (CBT) for 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.


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in brain activation (fMRI) after therapy [ Time Frame: Baseline & approximately 16-20 weeks later ]
    The goal of this study is to use multimodal MRI to assess the functioning and structure of overlapping frontostriatal circuits in a large sample of unmedicated children and adolescents diagnosed with OCD before and after CBT. The brain activity of children and adolescents diagnosed with OCD will be compared to age matched healthy controls during performance of the simon task and our virtual reality (VR)-based assessment of multiple learning and memory systems. In addition, functional connectivity within frontostriatal circuits in children and adolescents with OCD will be compared to age matched healthy control children and adolescents.

  2. Change from baseline in fractional anisotropy (Diffusion tensor imaging) after therapy [ Time Frame: Baseline & approximately 16-20 weeks later ]
    Anatomical and Diffusion Tensor Imaging (DTI) data will be collected so that we can begin to identify any structural and organizational abnormalities in these neural systems in children and adolescents with OCD compared to healthy control participants.


Secondary Outcome Measures :
  1. Probabilistic Go/No-go reinforcement learning task [ Time Frame: Baseline & approximately 16-20 weeks later ]
    Participants will be presented with one of 5 images on each trial and must learn to press (i.e., 'Go') or not to press (i.e., 'No-Go') a button for each image.

  2. Continuous Performance Task [ Time Frame: Baseline & approximately 16-20 weeks later ]
    The Continuous Performance Task (CPT)is a standardized measure of sustained attention and impulsivity.

  3. Stroop Word-Color Interference [ Time Frame: Baseline & approximately 16-20 weeks later ]
    This is a classic task of cognitive interference that is comprised of 3 subtasks.


Eligibility Criteria

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Patient Inclusion Criteria:

  • Participants must be 5-17 at the time of consent
  • Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Diagnosis of OCD as the principal problem
  • Not on psychotropic medication and not receiving current psychotherapy for OCD
  • Written informed assent by the participants (8 and older) and consent by the parent
  • Participants and a parent/guardian must be able to read and understand English

Patient Exclusion Criteria:

  • DSM-IV current diagnosis of major depressive disorder, attention-deficit hyperactivity disorder, Tourette's/Tic Disorder, or substance/alcohol abuse
  • DSM-IV lifetime diagnosis of psychotic disorder, bipolar disorder, eating disorder, pervasive developmental disorder, or substance/alcohol abuse
  • Active suicidal ideation
  • Females who are pregnant or nursing
  • Major medical or neurological problems
  • Presence of metallic device or dental braces
  • IQ<80
  • A current or past diagnosis of pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS)
  • Individuals who are currently receiving CBT, other forms of psychotherapy, or psychotropic medications
  • Individuals who have received a full course of CBT in the past
  • A positive pregnancy test
  • Positive urine screen for illicit drugs
  • Inability of participant or parent/guardian to read or understand English

Healthy Control Inclusion Criteria:

  • Participants must be 5-17 at the time of consent
  • Written informed assent by the participants (8 and older) and consent by the parent
  • Participants and a parent/guardian must be able to read and understand English

Healthy Control Exclusion Criteria:

  • Any current or lifetime psychiatric diagnosis
  • Active suicidal ideation
  • Females who are pregnant or nursing
  • Major medical or neurological problems
  • Presence of metallic device or dental braces
  • IQ<80
  • A current or past diagnosis of pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS)
  • A positive pregnancy test
  • Positive urine screen for illicit drugs
  • Inability of participant or parent/guardian to read or understand English
Contacts and Locations

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): NCT02421315


Contacts
Contact: Emily Steinberg, B.A. 646-774-5875 esteinb@nyspi.columbia.edu

Locations
United States, New York
NY State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Rachel Marsh, Ph.D. New York Psychiatric Institute
More Information

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02421315     History of Changes
Other Study ID Numbers: 7006
R21MH101441 ( U.S. NIH Grant/Contract )
First Posted: April 20, 2015    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by New York State Psychiatric Institute:
OCD
Functional Magnetic Resonance Imaging (fMRI)
Magnetic Resonance Imaging (MRI)

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