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 : February 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obsessive Compulsive Disorder||Behavioral: Exposure & Response Prevention (EX/RP) and when indicated medication treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Overlapping Neural Circuits Implicated in Pediatric OCD|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||May 2018|
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.
- 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.
- 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.
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
|Contact: Emily Steinberg, B.A.||email@example.com|
|United States, New York|
|NY State Psychiatric Institute||Recruiting|
|New York, New York, United States, 10032|
|Principal Investigator:||Rachel Marsh, Ph.D.||New York Psychiatric Institute|