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 range7 Years – 18 Years
SexALL
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
✕. 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