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
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Sponsor:
New York State Psychiatric Institute
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute
Tracking Information | |||||
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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 |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT02421315 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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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 |
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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. |
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Study Arms | Experimental: OCD
Participants will have a current diagnosis of OCD.
Intervention: Behavioral: Exposure & Response Prevention (EX/RP) and when indicated medication treatment |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
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:
Patient Exclusion Criteria:
Healthy Control Inclusion Criteria:
Healthy Control Exclusion Criteria:
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Sex/Gender |
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Ages | 5 Years to 17 Years (Child) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE |
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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 ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
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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 |
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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 |