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Celecoxib for Obsessive-Compulsive Disorder
Phase 2
Waitlist Available
Led By Jeffrey Miller, M.D.
Research Sponsored by New York State Psychiatric Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 to 55 years old
Principal diagnosis of Obsessive-Compulsive Disorder (OCD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if adding the anti-inflammatory drug celecoxib to current treatments helps adults with OCD who still have symptoms. It focuses on patients with high brain inflammation, measured by scans and blood tests, to see if they improve more with this added medication. Celecoxib has been tested as an additional therapy in schizophrenia, showing significant improvement in symptoms, particularly in patients with recent-onset schizophrenia.
Who is the study for?
This trial is for adults aged 18-55 with Obsessive-Compulsive Disorder (OCD) who still have symptoms despite current medication. Participants must be able to consent and not have medical conditions or metal implants that could interfere with brain scans, nor take medications like antipsychotics or steroids that affect the study drug.
What is being tested?
The study tests if celecoxib, an anti-inflammatory medicine, can help people with OCD when added to their existing treatment. It involves measuring inflammation in the brain and blood to see if these can predict the benefit from celecoxib.
What are the potential side effects?
Celecoxib may cause digestive issues like stomach pain and heartburn, kidney problems, swelling in legs or arms due to fluid retention, increased risk of heart attack or stroke, and allergic reactions such as rash.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 55 years old.
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My main diagnosis is Obsessive-Compulsive Disorder.
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My OCD symptoms persist despite taking psychiatric medication.
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I am between 18 and 55 years old.
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I understand and can agree to the study's procedures and risks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Yale-Brown Obsessive Compulsive Scale
Secondary study objectives
CRP
MILLIPLEX MAP Human Cytokine/Chemokine Magnetic Bead Panel
PGE2
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Celecoxib TreatmentExperimental Treatment1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Celecoxib
2019
Completed Phase 4
~1740
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Obsessive-Compulsive Disorder (OCD) include selective serotonin reuptake inhibitors (SSRIs) and cognitive-behavioral therapy (CBT). SSRIs increase serotonin levels in the brain, which helps alleviate OCD symptoms by improving mood and reducing anxiety.
CBT, especially exposure and response prevention (ERP), helps patients face their fears and reduce compulsive behaviors. Additionally, anti-inflammatory medications like celecoxib are being studied for their potential to reduce neuroinflammation, which may contribute to OCD symptoms.
Understanding these mechanisms is important for developing effective treatment plans tailored to individual patient needs.
Find a Location
Who is running the clinical trial?
New York State Psychiatric InstituteLead Sponsor
479 Previous Clinical Trials
153,809 Total Patients Enrolled
25 Trials studying Obsessive-Compulsive Disorder
967 Patients Enrolled for Obsessive-Compulsive Disorder
Jeffrey Miller, M.D.Principal Investigator - New York State Psychiatric Institute
New York Presbyterian Hospital-Columbia Presbyterian Center, New York State Psychiatric Institute
Yale University School Of Medicine (Medical School)
Ny And Presby Hospital (Residency)
1 Previous Clinical Trials
25 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot have an MRI or PET scan because you have metal implants.I am between 18 and 55 years old.My main diagnosis is Obsessive-Compulsive Disorder.My OCD symptoms persist despite taking psychiatric medication.I am between 18 and 55 years old.I am not taking any medications that could affect the study drug.I understand and can agree to the study's procedures and risks.You have mental health conditions that could make it risky for you to take part in the study or affect the study results (for example, thoughts of harming yourself).I started a new OCD treatment within the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Celecoxib Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.