Adjunctive Celecoxib in Childhood-onset OCD Study (NCT04673578) | Clinical Trial Compass
UnknownPhase 2
Adjunctive Celecoxib in Childhood-onset OCD Study
Canada80 participantsStarted 2021-06-01
Plain-language summary
This is a randomized, controlled, single-centre phase II superiority trial to determine the efficacy of 12 weeks of celecoxib (50 mg or 100 mg orally twice daily, dosed based on weight) compared to placebo as an adjunct to treatment-as-usual in children and youth with moderate-to-severe obsessive-compulsive disorder.
Who can participate
Age range
7 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 7-18 years
. Resident of British Columbia
. DSM-5 diagnosis of OCD based on (a) history of prior clinician assessment and (b) standardized interview
. CY-BOCS score ≥16 (moderate to severe)
. Able to take medication twice daily in capsule form (in whole form or sprinkled contents)
. Negative pregnancy test (either serum or urine) in participants with child-bearing potential
. Use of highly effective and/or double barrier contraception, or abstinence, in participants with child-bearing potential
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Lifetime diagnosis of renal disease, liver disease, gastrointestinal bleeding, peptic ulcer disease, inflammatory bowel disease, severe or uncontrolled asthma, bleeding disorders, heart disease, heart failure, or hypertension
. Current major depressive episode, acute psychosis, active substance use, suicidality, or restriction of fluid intake
. Pregnant or breastfeeding during the study period
. Active infection or antibiotic treatment at baseline
. Allergy to celecoxib, sulfonamide compounds, or NSAIDs, including aspirin
. Current or previous regular use of immune-modulating therapies for treatment of OCD symptoms, at an effective anti-inflammatory dose (including NSAIDs, corticosteroids, or biologics)
. Use of NSAIDs at any dose at a frequency ≥ 3 times per week during the 2 months prior to randomization
. Current use of intravenous or oral corticosteroids