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Control and Reward Circuits in Obsessive Compulsive Disorder

Primary Purpose

Obsessive-Compulsive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exposure & Response Prevention (EX/RP)
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obsessive-Compulsive Disorder focused on measuring OCD, Functional Magnetic Resonance Imaging (fMRI)

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for Patients:

  • Male and females with OCD aged 18-55
  • Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Diagnosis of OCD
  • Not on psychotropic medication

Exclusion Criteria for Patients:

  • Presence of metallic devices or dental braces in the body that are contraindicators for MR imaging
  • Comorbid psychiatric conditions that significantly elevate the risk of study participation (e.g. psychotic disorders, bipolar disorder, evidence of dementia or other cognitive disorder, suicidality)
  • Unstable medical conditions that need attention and would make participation in the study unsafe (e.g. very high blood pressure)
  • Use of psychotropic medication
  • Females who are pregnant or post-menopausal

Inclusion Criteria for Healthy Volunteers

- Male and females aged 18-55

Exclusion Criteria for Healthy Volunteers

  • Presence of metallic devices or dental braces in the body that are contraindicators for MR imaging
  • Any psychiatric diagnosis
  • Use of psychotropic medication
  • Diagnosis of OCD in a first degree relative
  • Females who are pregnant or post-menopausal
  • Unstable medical conditions that need attention and would make participation in the study unsafe (e.g. very high blood pressure)

Sites / Locations

  • NY State Psychiatric Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with OCD

Arm Description

Behavioral: Exposure & Response Prevention (EX/RP)

Outcomes

Primary Outcome Measures

Change from baseline in brain activation (fMRI) and fractional anisotropy (Diffusion tensor imaging) after therapy

Secondary Outcome Measures

Change in reaction times and correct responses on Stop signal reaction time task

Full Information

First Posted
August 18, 2014
Last Updated
March 12, 2019
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02221518
Brief Title
Control and Reward Circuits in Obsessive Compulsive Disorder
Official Title
Control & Reward Circuits as Targets for Repetitive Thoughts and Behaviors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to examine the brain functioning of OCD patients and healthy controls 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. We will use multimodal imaging to investigate neural circuits that support cognitive control and reward processing, using 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 transdiagnostic studies. The long-term goal is to identify control and reward circuit-abnormalities as targets for new transdiagnostic treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
OCD, Functional Magnetic Resonance Imaging (fMRI)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with OCD
Arm Type
Experimental
Arm Description
Behavioral: Exposure & Response Prevention (EX/RP)
Intervention Type
Behavioral
Intervention Name(s)
Exposure & Response Prevention (EX/RP)
Intervention Description
Exposure and Response Prevention (EX/RP) is a type of Cognitive Behavioral Treatment for treating OCD.
Primary Outcome Measure Information:
Title
Change from baseline in brain activation (fMRI) and fractional anisotropy (Diffusion tensor imaging) after therapy
Time Frame
Baseline & approximately 10 weeks later
Secondary Outcome Measure Information:
Title
Change in reaction times and correct responses on Stop signal reaction time task
Time Frame
Baseline and approximately 10 weeks later, at second scan

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for Patients: Male and females with OCD aged 18-55 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Diagnosis of OCD Not on psychotropic medication Exclusion Criteria for Patients: Presence of metallic devices or dental braces in the body that are contraindicators for MR imaging Comorbid psychiatric conditions that significantly elevate the risk of study participation (e.g. psychotic disorders, bipolar disorder, evidence of dementia or other cognitive disorder, suicidality) Unstable medical conditions that need attention and would make participation in the study unsafe (e.g. very high blood pressure) Use of psychotropic medication Females who are pregnant or post-menopausal Inclusion Criteria for Healthy Volunteers - Male and females aged 18-55 Exclusion Criteria for Healthy Volunteers Presence of metallic devices or dental braces in the body that are contraindicators for MR imaging Any psychiatric diagnosis Use of psychotropic medication Diagnosis of OCD in a first degree relative Females who are pregnant or post-menopausal Unstable medical conditions that need attention and would make participation in the study unsafe (e.g. very high blood pressure)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blair Simpson, MD, Ph.D
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
NY State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33446895
Citation
Shi TC, Pagliaccio D, Cyr M, Simpson HB, Marsh R. Network-based functional connectivity predicts response to exposure therapy in unmedicated adults with obsessive-compulsive disorder. Neuropsychopharmacology. 2021 Apr;46(5):1035-1044. doi: 10.1038/s41386-020-00929-9. Epub 2021 Jan 14.
Results Reference
derived
PubMed Identifier
31548396
Citation
Pagliaccio D, Middleton R, Hezel D, Steinman S, Snorrason I, Gershkovich M, Campeas R, Pinto A, Van Meter P, Simpson HB, Marsh R. Task-based fMRI predicts response and remission to exposure therapy in obsessive-compulsive disorder. Proc Natl Acad Sci U S A. 2019 Oct 8;116(41):20346-20353. doi: 10.1073/pnas.1909199116. Epub 2019 Sep 23.
Results Reference
derived

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Control and Reward Circuits in Obsessive Compulsive Disorder

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