Clinical trial NCT02221518: Control and Reward Circuits in Obsessive Compulsive Disorder
Official title: Control & Reward Circuits as Targets for Repetitive Thoughts and Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
Functional Magnetic Resonance Imaging (fMRI)
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2014-08-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Change from baseline in brain activation (fMRI) and fractional anisotropy (Diffusion tensor imaging) after therapy
timeFrame: Baseline & approximately 10 weeks later
Secondary outcomes:
measure: Change in reaction times and correct responses on Stop signal reaction time task
timeFrame: Baseline and approximately 10 weeks later, at second scan
Other outcomes:
Locations:
city: New York
country: United States
facility: NY State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Blair Simpson, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.