Obsessive-Compulsive DisorderNCT05195476
Neural Correlates of Compulsivity
An observational study of Obsessive-Compulsive Disorder, run by Columbia University at 1 site in United States.
Trial summary
This study aims to collect data from individuals with obsessive-compulsive disorder (OCD) and healthy controls in order to clarify how learning strategies are employed differently by individuals with compulsive psychopathology and healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2021to 28 Feb 2024
- Phase
- Observational
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Individuals diagnosed with OCD and healthy controls
Who may be able to join
- Between 18-50 years of age
- English-speaking
- Capacity to provide informed consent
- Primary diagnosis of OCD with at least moderate severity
Who cannot join
- Current or lifetime history of psychiatric disorders other than OCD that may increase the risk of participation
- History of any significant medical condition that may increase the risk of participation
- Alcohol or substance use disorder in the past year
- Exposure and response prevention for OCD within the last six weeks
- Currently taking psychotropic medication
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
This study aims to collect data from individuals with obsessive-compulsive disorder (OCD) and healthy controls in order to clarify how learning strategies are employed differently by individuals with compulsive psychopathology and healthy individuals. Behavioral and electroencephalogram (EEG) data will be collected during one experimental reinforcement learning tasks from participants diagnosed with OCD (n = 30) and healthy controls (n = 30). Computational modeling, an advanced data analytic approach that can directly link neural measures with behavior, will be used to quantify learning processes. These parameters then will be related to measures of neural events obtained using EEG, a neuroimaging method that has high temporal resolution, to test for evidence of neurocognitive alterations.
Read the detailed description
Learning and decisions making are thought to be directed by multiple parallel cognitive systems. These systems account for automatic, inflexible responding to stimuli, as well as more deliberate, effortful representations of relationships in an environment. It has long been suggested than an imbalance in these cognitive control systems explains the emergence of compulsivity, a trait in which behaviors persist despite adverse outcomes. Compulsivity is a characteristic of a number of psychological disorders, however, current theories of how abnormalities in cognitive systems involved in learning and decision making lead to the onset of these disorders remain incomplete.
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Compulsivity, Obsessive-Compulsive Disorder, Exposure and Response Prevention, Electroencephalogram
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Individuals diagnosed with OCD | Individuals diagnosed with OCD | |
| Healthy controls | Individuals who have not been diagnosed with any psychiatric disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural Activity
EEG will be recorded while participants complete computerized reinforcement learning tasks at one study visit
Measured: One-time study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start17 Dec 2021
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- International OCD Foundation
- Responsible party
- Principal investigator, Amy Rapp, Columbia University
- Investigators
- Amy Rapp, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195476
- Sponsor's protocol ID
- 7867
- Status last verified
- May 2024
- First submitted
- 4 Jan 2022
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Compulsivity
- ClinicalTrials.gov ID
- NCT05195476
- Acronym / sponsor ID
- 7867
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Compulsivity, Obsessive-Compulsive Disorder, Exposure and Response Prevention, Electroencephalogram
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- International OCD Foundation
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 19 Jan 2022 (actual)
- 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.
This study aims to collect data from individuals with obsessive-compulsive disorder (OCD) and healthy controls in order to clarify how learning strategies are employed differently by individuals with compulsive psychopathology and healthy individuals. Behavioral and electroencephalogram (EEG) data will be collected during one experimental reinforcement learning tasks from participants diagnosed with OCD (n = 30) and healthy controls (n = 30). Computational modeling, an advanced data analytic approach that can directly link neural measures with behavior, will be used to quantify learning processes. These parameters then will be related to measures of neural events obtained using EEG, a neuroimaging method that has high temporal resolution, to test for evidence of neurocognitive alterations.
Detailed description
Learning and decisions making are thought to be directed by multiple parallel cognitive systems. These systems account for automatic, inflexible responding to stimuli, as well as more deliberate, effortful representations of relationships in an environment. It has long been suggested than an imbalance in these cognitive control systems explains the emergence of compulsivity, a trait in which behaviors persist despite adverse outcomes. Compulsivity is a characteristic of a number of psychological disorders, however, current theories of how abnormalities in cognitive systems involved in learning and decision making lead to the onset of these disorders remain incomplete.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals diagnosed with OCD | – | –Individuals diagnosed with OCD |
| Healthy controls | – | –Individuals who have not been diagnosed with any psychiatric disorders |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Individuals diagnosed with OCD and healthy controls
Key inclusion criteria (4 listed)
- Between 18-50 years of age
- English-speaking
- Capacity to provide informed consent
- Primary diagnosis of OCD with at least moderate severity
Key exclusion criteria (5 listed)
- Current or lifetime history of psychiatric disorders other than OCD that may increase the risk of participation
- History of any significant medical condition that may increase the risk of participation
- Alcohol or substance use disorder in the past year
- Exposure and response prevention for OCD within the last six weeks
- Currently taking psychotropic medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neural Activity
Time frame: One-time study visit
EEG will be recorded while participants complete computerized reinforcement learning tasks at one study visit
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 6 May 2024.
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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.
Amy Rapp, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obsessive-Compulsive Disorder, run by Columbia University 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 5 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 6 May 2024. 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?
Neural Activity (time frame: One-time study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2024.