Obsessive-Compulsive DisorderNCT02221518
Control and Reward Circuits in Obsessive Compulsive Disorder
A study testing Exposure & Response Prevention (EX/RP) in people with Obsessive-Compulsive Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Exposure & Response Prevention (EX/RP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and females with OCD aged 18-55
- Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Diagnosis of OCD
- Not on psychotropic medication
- Male and females aged 18-55
Who cannot join
- 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
- Presence of metallic devices or dental braces in the body that are contraindicators for MR imaging
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
NY State Psychiatric Institute
New York, New York, 10032
About this study
Official title: 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.
Read the 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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Exposure & Response Prevention (EX/RP)
- Keywords
- OCD, Functional Magnetic Resonance Imaging (fMRI)
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure & Response Prevention (EX/RP)Behavioural
Exposure and Response Prevention (EX/RP) is a type of Cognitive Behavioral Treatment for treating OCD.
| Study group | Role | What they receive |
|---|---|---|
| Patients with OCD | Experimental | Behavioral: Exposure \& Response Prevention (EX/RP) Receives: Behavioral: Exposure & Response Prevention (EX/RP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in brain activation (fMRI) and fractional anisotropy (Diffusion tensor imaging) after therapy
Measured: Baseline & approximately 10 weeks later
Secondary outcomes (1)
Change in reaction times and correct responses on Stop signal reaction time task
Measured: Baseline and approximately 10 weeks later, at second scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen Blair Simpson, New York State Psychiatric Institute
- Investigators
- Blair Simpson, MD, Ph.D, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221518
- Sponsor's protocol ID
- #7000/R01MH104648-01
- Status last verified
- Mar 2019
- First submitted
- 18 Aug 2014
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 39879875Shi 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.
PubMed 33446895Pagliaccio 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.
PubMed 31548396
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control & Reward Circuits as Targets for Repetitive Thoughts and Behaviors
- ClinicalTrials.gov ID
- NCT02221518
- Acronym / sponsor ID
- #7000/R01MH104648-01
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- OCD, Functional Magnetic Resonance Imaging (fMRI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jun 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 20 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with OCD | Experimental | Behavioral: Exposure & Response Prevention (EX/RP)Behavioral: Exposure \& Response Prevention (EX/RP) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and females with OCD aged 18-55
- Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Diagnosis of OCD
- Not on psychotropic medication
- Male and females aged 18-55
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure & Response Prevention (EX/RP)Exposure and Response Prevention (EX/RP) is a type of Cognitive Behavioral Treatment for treating OCD. | Behavioural | Patients with OCD |
Primary outcome
Change from baseline in brain activation (fMRI) and fractional anisotropy (Diffusion tensor imaging) after therapy
Time frame: Baseline & approximately 10 weeks later
1 secondary outcome
Change in reaction times and correct responses on Stop signal reaction time task
Time frame: Baseline and approximately 10 weeks later, at second scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Derived from this study: PubMed 39879875Wheaton 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.
- Derived from this study: PubMed 33446895Shi 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.
- Derived from this study: PubMed 31548396Pagliaccio 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blair Simpson, MD, Ph.D principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure & Response Prevention (EX/RP) in people with Obsessive-Compulsive Disorder, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in brain activation (fMRI) and fractional anisotropy (Diffusion tensor imaging) after therapy (time frame: Baseline & approximately 10 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02221518, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.