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Celecoxib for Obsessive-Compulsive Disorder

Phase 2
Recruiting
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
Ongoing OCD symptoms despite current treatment with psychiatric medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will help researchers understand if anti-inflammatory drugs can be effective in treating OCD when used in addition to traditional medications.

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.Check my eligibility
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.See study design
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 below
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I am between 18 and 55 years old.
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My OCD symptoms persist despite current medication.
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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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My main diagnosis is Obsessive-Compulsive Disorder.
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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.
Select...
My OCD symptoms persist despite current medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Yale-Brown Obsessive Compulsive Scale
Secondary outcome measures
CRP
MILLIPLEX MAP Human Cytokine/Chemokine Magnetic Bead Panel
PGE2
+2 more

Side effects data

From 2010 Phase 2 trial • 255 Patients • NCT01062113
5%
Beta 2 microglobulin increased
3%
Beta-N-acetyl-D-glucosaminidase increased
3%
Blood bilirubin increased
2%
Eczema
1%
White blood cell count increased
1%
Blood urine present
1%
Hypoaesthesia facial
1%
Rash
1%
Post procedural haemorrhage
1%
Blood creatine phosphokinase increased
1%
Blood phosphorus decreased
1%
Urobilin urine present
1%
Presyncope
1%
Somnolence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Initial Dose Celecoxib 400 mg
Additional Dose Celecoxib 200 mg
Additional Dose Placebo

Awards & 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

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor
474 Previous Clinical Trials
153,236 Total Patients Enrolled
24 Trials studying Obsessive-Compulsive Disorder
926 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

Celecoxib Clinical Trial Eligibility Overview. Trial Name: NCT04786548 — Phase 2
Obsessive-Compulsive Disorder Research Study Groups: Celecoxib Treatment
Obsessive-Compulsive Disorder Clinical Trial 2023: Celecoxib Highlights & Side Effects. Trial Name: NCT04786548 — Phase 2
Celecoxib 2023 Treatment Timeline for Medical Study. Trial Name: NCT04786548 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Celecoxib been endorsed by the FDA?

"The safety of Celecoxib has been assessed by Power personnel, and it was assigned a 2 on the 1-3 scale. This evaluation is based off Phase 2 trial findings which indicate there are some data supporting its safety but none verifying its efficacy."

Answered by AI

Who would be the ideal candidates to participate in this medical experiment?

"This clinical trial seeks 21 individuals aged between 18 and 55, who suffer from obsessive-compulsive disorder. The key prerequisites for selection are to be within the specified age range and present a persistent case of OCD despite being medicated with psychiatric medication."

Answered by AI

What is the cap on participant numbers for this trial?

"Affirmative. The information on clinicaltrials.gov indicates that this medical experiment is now seeking participants, with the initial posting taking place on April 1st 2021 and most recent update occuring on July 29th 2022. 21 patients need to be recruited from a single site for enrollment in this trial."

Answered by AI

Does the protocol for this research exclude individuals who have surpassed their eightieth birthday?

"This clinical trial is recruiting volunteers aged 18 and above, but below the age of 55."

Answered by AI

Are there any recruitment opportunities for this research endeavor at present?

"Correct. According to clinicaltrials.gov, this ongoing study is currently enrolling patients and was posted on April 1st 2021 with its most recent update being July 29th 2022. 21 individuals are needed from a single medical centre for the trial's completion."

Answered by AI

What medical applications has Celecoxib been effective for?

"Celecoxib is a common form of pain relief, though its applications extend to primary dysmenorrhoea, rheumatoid arthritis, and ankylosing spondylitis."

Answered by AI

Who else is applying?

What state do they live in?
New York
New Jersey
How old are they?
18 - 65
What site did they apply to?
New York State Psychiatric Institute
What portion of applicants met pre-screening criteria?
Met criteria
~1 spots leftby Apr 2024