Control and Reward Circuits in Obsessive Compulsive Disorder | NCT02221518

Studies
Control and Reward Circuits in Obsessive Compulsive Disorder

NCT02221518

Sponsor

New York State Psychiatric Institute

Status

Completed

Last Update Posted

Mar 13, 2019Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Obsessive-Compulsive Disorder

Interventions

Exposure & Response Prevention (EX/RP)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Jun 2018Actual

Completion Date

Aug 2018Actual

First Submitted Date

Aug 18, 2014

First Submission Date that Met QC Criteria

Aug 19, 2014

First Posted Date

Aug 20, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2019

Last Update Posted Date

Mar 13, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Helen Blair Simpson, Professor of Psychiatry-Columbia University Medical Center, Columbia University; Director of Anxiety Disorders Clinic & Center for OCD and Related Disorders, New York State Psychiatric InstitutePrincipal Investigator

Lead Sponsor

New York State Psychiatric InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with OCD	Experimental	Behavioral: Exposure & Response Prevention (EX/RP)	Behavioral: Exposure & Response Prevention (EX/RP)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exposure & Response Prevention (EX/RP)	Behavioral	Exposure and Response Prevention (EX/RP) is a type of Cognitive Behavioral Treatment for treating OCD.	Patients with OCD

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Blair Simpson, MD, Ph.D	New York State Psychiatric Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
NY State Psychiatric Institute		New York	New York	10032	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39879875	Derived	Wheaton MG, Kalanthroff E, Mandel M, Marsh R, Simpson HB. Neurocognitive performance in obsessive-compulsive disorder before and after treatment with cognitive behavioral therapy. J Behav Ther Exp Psychiatry. 2025 Jun;87:102019. doi: 10.1016/j.jbtep.2025.102019. Epub 2025 Jan 20.
33446895	Derived	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.

ID	Term
D001008	Anxiety Disorders
D001523	Mental Disorders