Adjunctive Celecoxib in Childhood-onset OCD Study

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Collaborators: BC Children's Hospital Research Institute; International Obsessive-Compulsive Disorder Foundation; Obsessive Compulsive Foundation
• Treatments: Celecoxib

Criteria

Inclusion Criteria:

• Age 7-18 years

• Resident of British Columbia

• Diagnostic and Statistical Manual of Mental Disorders-5 (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 autism spectrum disorder, bipolar disorder, psychotic disorder, substance-use disorder, intellectual disability, significant head injury causing loss of consciousness, 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 corticosteroids (IV, oral, inhaled, intranasal, or high-potency topical)

• Concurrent use of CYP2C9 inhibitors fluconazole, amiodarone, oxandrolone or methotrexate; CYP2C9 inducers including rifampin and phenobarbital; or any other drug that may interact with celecoxib and, in the opinion of Dr. Stewart or another study investigator, represents a potential safety risk

• Poor CYP2C9 metabolizer (e.g. known CYP2C9*3/*3 genotype) based on clinical suspicion or previous genotyping

• Abnormality identified on baseline serology including leukocytosis, leukopenia, thrombocytopenia, anemia, abnormal renal function (Cr > 1.5 x upper limit of normal), or abnormal liver function: alanine aminotransferase (ALT), alkaline phosphatase (ALP), or aspartate aminotransferase (AST) > 1.5x upper limit of normal)

• New medication started in the 10 weeks prior to baseline, or change in dose in the 4 weeks prior to baseline

• Changes in cognitive behavioural therapy (CBT) or other psychotherapy in the 4 weeks prior to baseline (i.e. change in regular frequency, modality, or care provider)

• Notable other treatment changes during the study period (either pharmacotherapy or psychotherapy)

• No regular primary care provider (family doctor, nurse practitioner, or specialist) providing usual medical care

• Participant/parents unable to provide informed consent or assent or participate in self-care, adverse event reporting, or follow-up assessments

• Inability to have blood pressure measured within 2 months prior to enrollment (either on-site at BCCH or by a primary care provider)

• Intention of pregnancy in participants with child-bearing potential