Control and Reward Circuits in Obsessive Compulsive Disorder

March 12, 2019 updated by: Helen Blair Simpson, New York State Psychiatric Institute

Control & Reward Circuits as Targets for Repetitive Thoughts and Behaviors

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.

Study Overview

Status

Completed

Conditions

Intervention / 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. 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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • NY State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with OCD
Behavioral: Exposure & Response Prevention (EX/RP)
Behavioral: Exposure & Response Prevention (EX/RP)
Exposure and Response Prevention (EX/RP) is a type of Cognitive Behavioral Treatment for treating OCD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in brain activation (fMRI) and fractional anisotropy (Diffusion tensor imaging) after therapy
Time Frame: Baseline & approximately 10 weeks later
Baseline & approximately 10 weeks later

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in reaction times and correct responses on Stop signal reaction time task
Time Frame: Baseline and approximately 10 weeks later, at second scan
Baseline and approximately 10 weeks later, at second scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Investigators

  • Principal Investigator: Blair Simpson, MD, Ph.D, New York State Psychiatric Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

August 18, 2014

First Submitted That Met QC Criteria

August 19, 2014

First Posted (Estimate)

August 20, 2014

Study Record Updates

Last Update Posted (Actual)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #7000/R01MH104648-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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