Obsessive-Compulsive DisorderPhase 2NCT04786548
Neuroinflammation in Patients With OCD
A Phase 2 study testing Celecoxib in people with Obsessive-Compulsive Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The goal of this study is to examine whether measurements of inflammation from brain scanning and blood tests can predict how much benefit patients with obsessive-compulsive disorder (OCD) will have from treatment with an anti-inflammatory medication, celecoxib, when adding to ongoing medication-based treatment for… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Celecoxib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 28 Oct 2026
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 55 years old
- Principal diagnosis of Obsessive-Compulsive Disorder (OCD)
- Ongoing OCD symptoms despite current treatment with psychiatric medication
- Capacity to provide informed consent
Who cannot join
- Psychiatric comorbidities that would increase risk of participation or impact research measures (e.g., suicidality)
- Medical or neurological conditions that would increase risk of participation or impact research measures
- Contraindications to an MRI or PET scan (e.g., metal implants)
- Current use of medications that may interact with study drug or impact research measures (e.g., antipsychotics, corticosteroids, immunosuppressant medications, or daily non-steroidal anti-inflammatory medications)
- Starting a new evidence-based therapy for OCD (e.g., exposure with response prevention) 4 weeks prior to study enrollment
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
Official title: A Precision Medicine Approach to OCD Treatment: Targeting Neuroinflammation
The goal of this study is to examine whether measurements of inflammation from brain scanning and blood tests can predict how much benefit patients with obsessive-compulsive disorder (OCD) will have from treatment with an anti-inflammatory medication, celecoxib, when adding to ongoing medication-based treatment for OCD.
Read the detailed description
Existing evidence-based treatments for adults with obsessive-compulsive disorder (OCD), including cognitive behavioral therapy and first-line medication-based treatment, do not fully resolve symptoms for a majority of patients. This study proposes to test a new treatment strategy for OCD, examining inflammation as one factor that may contribute to the development of OCD and that may be targeted with medication-based treatment. Recent findings using both brain imaging and analyses from blood samples suggest that some individuals with OCD have increased levels of inflammation in the brain, which may have negative effects on brain function, contributing to symptoms of OCD. Moreover, early clinical studies suggest that some medications with anti-inflammatory properties may be beneficial in treating OCD symptoms. An important and untested question is whether the degree of inflammation assessed using these biological tools can predict how much benefit individuals with OCD will derive from treatment with an anti-inflammatory medication. The investigators will measure inflammation in the brain using PET imaging and measures of inflammation in the body using blood tests in adults with OCD. Patients will then undergo 8 weeks of treatment with an anti-inflammatory medication with some evidence of clinical effectiveness in OCD, celecoxib. The investigators predict that OCD patients with greater evidence of inflammation at baseline, assessed by brain imaging and blood tests, will derive the greatest benefit from anti-inflammatory treatment. In addition, the investigators will compare these inflammatory markers with data from a group of healthy volunteers (collected as part of another protocol, IRB #6786), to extend earlier work finding elevated inflammatory markers in adult OCD. Finally, the investigators will examine whether celecoxib treatment in OCD patients results in reductions in measures of inflammation measured from blood samples and whether the degree of anti-inflammatory effect observed biologically is related to improvement in OCD symptoms. The ultimate goal of this line of research is to pave the way for more individually-tailored, effective treatments for adult OCD based on improved understandings of pathological targets, and to validate an anti-inflammatory approach to the treatment of OCD in individuals with evidence of inflammation.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Celecoxib
- Keywords
- Obsessive-Compulsive Disorder, OCD, Neuroinflammation, Nonsteroidal anti-inflammatory drug, Celecoxib
- Medical subject headings
- Obsessive-Compulsive Disorder, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Also called Celebrex
Patients will receive standardized pharmacotherapy with celecoxib 100mg twice daily for the first week, and will then, if well-tolerated, will be increased to 200mg twice daily for the next seven weeks.
| Study group | Role | What they receive |
|---|---|---|
| Celecoxib Treatment | Experimental | Patients will receive standardized pharmacotherapy with celecoxib 100mg twice daily for the first week, and will then, if well-tolerated, will be increased to 200mg twice daily for the next seven weeks. Visits with the study psychiatrist will occur weekly for the first four weeks, and biweekly thereafter until week 8, which will be conducted remotely in general, although they may be conducted in-person as clinically warranted and may be conducted in person on the days of other in-person visits. If individuals experience significant side-effects from a given dose, the treating physician may lower the medication dose according to clinical judgment; if side-effects are intolerable, we will discontinue the research procedures and advance to open clinical treatment Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive Compulsive Scale
The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is a clinician-administered interview that measures the presence and severity of symptoms of Obsessive-Compulsive Disorder. It consists of 10 questions with scores ranging from 0 to 4, with a possible score ranging from 0 to 40. The primary measure of clinical improvement in this study is the Week 8 YBOCS score. In statistical models, we will co-vary for the Week 0 YBOCS score to account for baseline symptoms severity, but the Week 8 value is the primary outcome.
Measured: Week 8
Secondary outcomes (7)
TSPO Volume of Distribution assessed by PET imaging with [11C]ER-176
We will perform PET imaging with the [11C]ER-176 radiotracer to quantify TSPO binding, a marker of neuroinflammation, quantified as the outcome measure Volume of Distribution (VT).
Measured: Baseline
PGE2
prostaglandin E2 levels will be measured in serum.
Measured: Baseline
PGE2
prostaglandin E2 levels will be measured in serum.
Measured: Week 8
PGF2-alpha
Prostaglandin F2-alpha levels will be measured in serum.
Measured: Week 0
PGF2-alpha
Prostaglandin F2-alpha levels will be measured in serum.
Measured: Week 8
CRP
C-reactive protein levels will be measured in serum.
Measured: Week 0
CRP
C-reactive protein levels will be measured in serum.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start1 Apr 2021
- Primary completion28 Oct 2026
- Study completion28 Oct 2026
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.
- 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 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Miller, New York State Psychiatric Institute
- Investigators
- Jeffrey Miller, M.D., Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786548
- Sponsor's protocol ID
- 8115
- Status last verified
- Oct 2026
- First submitted
- 1 Mar 2021
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Precision Medicine Approach to OCD Treatment: Targeting Neuroinflammation
- ClinicalTrials.gov ID
- NCT04786548
- Acronym / sponsor ID
- 8115
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Obsessive-Compulsive Disorder, OCD, Neuroinflammation, Nonsteroidal anti-inflammatory drug, Celecoxib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 28 Oct 2026 (actual)
- Study completion
- 28 Oct 2026 (actual)
- First posted
- 8 Mar 2021 (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.
The goal of this study is to examine whether measurements of inflammation from brain scanning and blood tests can predict how much benefit patients with obsessive-compulsive disorder (OCD) will have from treatment with an anti-inflammatory medication, celecoxib, when adding to ongoing medication-based treatment for OCD.
Detailed description
Existing evidence-based treatments for adults with obsessive-compulsive disorder (OCD), including cognitive behavioral therapy and first-line medication-based treatment, do not fully resolve symptoms for a majority of patients. This study proposes to test a new treatment strategy for OCD, examining inflammation as one factor that may contribute to the development of OCD and that may be targeted with medication-based treatment. Recent findings using both brain imaging and analyses from blood samples suggest that some individuals with OCD have increased levels of inflammation in the brain, which may have negative effects on brain function, contributing to symptoms of OCD. Moreover, early clinical studies suggest that some medications with anti-inflammatory properties may be beneficial in treating OCD symptoms. An important and untested question is whether the degree of inflammation assessed using these biological tools can predict how much benefit individuals with OCD will derive from treatment with an anti-inflammatory medication. The investigators will measure inflammation in the brain using PET imaging and measures of inflammation in the body using blood tests in adults with OCD. Patients will then undergo 8 weeks of treatment with an anti-inflammatory medication with some evidence of clinical effectiveness in OCD, celecoxib. The investigators predict that OCD patients with greater evidence of inflammation at baseline, assessed by brain imaging and blood tests, will derive the greatest benefit from anti-inflammatory treatment. In addition, the investigators will compare these inflammatory markers with data from a group of healthy volunteers (collected as part of another protocol, IRB #6786), to extend earlier work finding elevated inflammatory markers in adult OCD. Finally, the investigators will examine whether celecoxib treatment in OCD patients results in reductions in measures of inflammation measured from blood samples and whether the degree of anti-inflammatory effect observed biologically is related to improvement in OCD symptoms. The ultimate goal of this line of research is to pave the way for more individually-tailored, effective treatments for adult OCD based on improved understandings of pathological targets, and to validate an anti-inflammatory approach to the treatment of OCD in individuals with evidence of inflammation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Celecoxib Treatment | Experimental | Drug: CelecoxibPatients will receive standardized pharmacotherapy with celecoxib 100mg twice daily for the first week, and will then, if well-tolerated, will be increased to 200mg twice daily for the next seven weeks. Visits with the study psychiatrist will occur weekly for the first four weeks, and biweekly thereafter until week 8, which will be conducted remotely in general, although they may be conducted in-person as clinically warranted and may be conducted in person on the days of other in-person visits. If individuals experience significant side-effects from a given dose, the treating physician may lower the medication dose according to clinical judgment; if side-effects are intolerable, we will discontinue the research procedures and advance to open clinical treatment |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 to 55 years old
- Principal diagnosis of Obsessive-Compulsive Disorder (OCD)
- Ongoing OCD symptoms despite current treatment with psychiatric medication
- Capacity to provide informed consent
Key exclusion criteria (5 listed)
- Psychiatric comorbidities that would increase risk of participation or impact research measures (e.g., suicidality)
- Medical or neurological conditions that would increase risk of participation or impact research measures
- Contraindications to an MRI or PET scan (e.g., metal implants)
- Current use of medications that may interact with study drug or impact research measures (e.g., antipsychotics, corticosteroids, immunosuppressant medications, or daily non-steroidal anti-inflammatory medications)
- Starting a new evidence-based therapy for OCD (e.g., exposure with response prevention) 4 weeks prior to study enrollment
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 |
|---|---|---|
| CelecoxibAlso: CelebrexPatients will receive standardized pharmacotherapy with celecoxib 100mg twice daily for the first week, and will then, if well-tolerated, will be increased to 200mg twice daily for the next seven weeks. | Drug | Celecoxib Treatment |
Primary outcome
Yale-Brown Obsessive Compulsive Scale
Time frame: Week 8
The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is a clinician-administered interview that measures the presence and severity of symptoms of Obsessive-Compulsive Disorder. It consists of 10 questions with scores ranging from 0 to 4, with a possible score ranging from 0 to 40. The primary measure of clinical improvement in this study is the Week 8 YBOCS score. In statistical models, we will co-vary for the Week 0 YBOCS score to account for baseline symptoms severity, but the Week 8 value is the primary outcome.
7 secondary outcomes
TSPO Volume of Distribution assessed by PET imaging with [11C]ER-176
Time frame: Baseline
PGE2
Time frame: Baseline
PGE2
Time frame: Week 8
PGF2-alpha
Time frame: Week 0
PGF2-alpha
Time frame: Week 8
CRP
Time frame: Week 0
CRP
Time frame: Week 8
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 30 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Jeffrey Miller, M.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 Phase 2 study testing Celecoxib 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 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 30 Oct 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Yale-Brown Obsessive Compulsive Scale (time frame: Week 8). 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 30 Oct 2026.