Overlapping Neural Circuits in Pediatric OCD

Tracking Information
First Submitted Date ICMJE	April 9, 2015
First Posted Date ICMJE	April 20, 2015
Last Update Posted Date	February 14, 2018
Study Start Date ICMJE	October 2014
Estimated Primary Completion Date	May 2018 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 12, 2017)	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.; 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.
Original Primary Outcome Measures ICMJE; (submitted: April 15, 2015)	Change from baseline in brain activation (fMRI) after therapy [ Time Frame: Baseline & approximately 16-20 weeks later ]; Change from baseline in fractional anisotropy (Diffusion tensor imaging) after therapy [ Time Frame: Baseline & approximately 16-20 weeks later ]
Change History	Complete list of historical versions of study NCT02421315 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 12, 2017)	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.; 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.; 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.
Original Secondary Outcome Measures ICMJE; (submitted: April 15, 2015)	Probabilistic Go/No-go reinforcement learning task [ Time Frame: Baseline & approximately 16-20 weeks later ]; Continuous Performance Task [ Time Frame: Baseline & approximately 16-20 weeks later ]; Stroop Word-Color Interference [ Time Frame: Baseline & approximately 16-20 weeks later ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Overlapping Neural Circuits in Pediatric OCD
Official Title ICMJE	Overlapping Neural Circuits Implicated in Pediatric OCD
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.
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 Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
Condition ICMJE	Obsessive Compulsive Disorder
Intervention ICMJE	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.
Study Arms	Experimental: OCD; Participants will have a current diagnosis of OCD.; Intervention: Behavioral: Exposure & Response Prevention (EX/RP) and when indicated medication treatment
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: April 15, 2015)	80
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	May 2018
Estimated Primary Completion Date	May 2018 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	5 Years to 17 Years (Child)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact: Emily Steinberg, B.A. 646-774-5875 esteinb@nyspi.columbia.edu
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT02421315
Other Study ID Numbers ICMJE	7006; R21MH101441 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: Yes
Responsible Party	New York State Psychiatric Institute
Study Sponsor ICMJE	New York State Psychiatric Institute
Collaborators ICMJE	National Institute of Mental Health (NIMH)
Investigators ICMJE	Principal Investigator: Rachel Marsh, Ph.D. New York Psychiatric Institute
PRS Account	New York State Psychiatric Institute
Verification Date	February 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP