ClinicalTrials.gov
ClinicalTrials.gov Menu

Control and Reward Circuits in Obsessive Compulsive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02221518
Recruitment Status : Recruiting
First Posted : August 20, 2014
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Behavioral: Exposure & Response Prevention (EX/RP) Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Control & Reward Circuits as Targets for Repetitive Thoughts and Behaviors
Study Start Date : October 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Change from baseline in brain activation (fMRI) and fractional anisotropy (Diffusion tensor imaging) after therapy [ Time Frame: Baseline & approximately 10 weeks later ]

Secondary Outcome Measures :
  1. Change in reaction times and correct responses on Stop signal reaction time task [ Time Frame: Baseline and approximately 10 weeks later, at second scan ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

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): NCT02221518


Contacts
Contact: Rachel Middleton, B.A. 646-774-8138 middlet@nyspi.columbia.edu

Locations
United States, New York
NY State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Blair Simpson, MD, Ph.D New York State Psychiatric Institute

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02221518     History of Changes
Other Study ID Numbers: #7000/R01MH104648-01
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

Keywords provided by New York State Psychiatric Institute:
OCD
Functional Magnetic Resonance Imaging (fMRI)

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders