Recruiting
Phase 2

Celecoxib

Sponsor:

University of British Columbia

Code:

NCT04673578

Conditions

Obsessive-Compulsive Disorder

Pediatric Psychiatric Disorder

Eligibility Criteria

Sex: All

Age: 7 - 18

Healthy Volunteers: Not accepted

Interventions

Celecoxib

Placebo

Study Details

Brief 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.

Conditions

Obsessive-Compulsive Disorder

Pediatric Psychiatric Disorder

Study ID

NCT04673578

Start date

Jun 1, 2021

Status verified date

Dec, 2022

Completion date

Jun, 2023

Anticipated

Primary completion date

Jun, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 7-18 years
2. Resident of British Columbia
3. DSM-5 diagnosis of OCD based on (a) history of prior clinician assessment and (b) standardized interview
4. CY-BOCS score ≥16 (moderate to severe)
5. Able to take medication twice daily in capsule form (in whole form or sprinkled contents)
6. Negative pregnancy test (either serum or urine) in participants with child-bearing potential
7. Use of highly effective and/or double barrier contraception, or abstinence, in participants with child-bearing potential

Exclusion Criteria:

1. 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
2. Current major depressive episode, acute psychosis, active substance use, suicidality, or restriction of fluid intake
3. Pregnant or breastfeeding during the study period
4. Active infection or antibiotic treatment at baseline
5. Allergy to celecoxib, sulfonamide compounds, or NSAIDs, including aspirin
6. 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)
7. Use of NSAIDs at any dose at a frequency ≥ 3 times per week during the 2 months prior to randomization
8. Current use of intravenous or oral corticosteroids
9. 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
10. Poor CYP2C9 metabolizer (i.e. CYP2C9\*3/\*3 genotype) based on clinical suspicion or previous genotyping.
11. 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 (ALT, ALP, or AST > 1.5x upper limit of normal)
12. New psychotropic medication (i.e. medication with known or potential impact on psychiatric symptoms, including selective serotonin reuptake inhibitors, benzodiazepines, antipsychotics, stimulants, anticonvulsants, mood stabilizers, or other medications) or other ongoing regular medication started in the 10 weeks prior to baseline, or change in dose in the 4 weeks prior to baseline
13. Changes in CBT or other psychotherapy in the 4 weeks prior to baseline (i.e. change in regular frequency, modality, or care provider)
14. Notable other treatment changes during the study period (either pharmacotherapy or psychotherapy)
15. No regular physician (family doctor or specialist) providing usual medical care
16. Participant/parents unable to provide informed consent or assent or participate in self-care, AE reporting, or follow-up assessments
17. Inability to have blood pressure measured within 2 months prior to enrollment (either on-site at BCCH or by a primary care provider).
18. Intention of pregnancy in participants with child-bearing potential.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Celecoxib

Celecoxib 50 mg orally twice daily (if weight 10-25 kg) or 100 mg orally twice daily (if weight > 25 kg) for 12 weeks. Used as adjunct to treatment-as-usual.

placebo comparator: Placebo (microcrystalline cellulose)

Placebo capsules identical to celecoxib. One capsule orally twice daily for 12 weeks. Used as adjunct to treatment-as-usual.

Interventions

Celecoxib

Selective COX-2 inhibitor; nonsteroidal anti-inflammatory drug (NSAID)

Placebo

Microcrystalline cellulose

Primary outcome measure

  • Children's Yale-Brown Obsessive-Compulsive Scale, 1st Edition (CY-BOCS-I) [ Time Frame: 12 weeks (adjusted for baseline severity) ]

Central Contacts and Locations

Central contacts

Research Assistant, Provincial OCD Program

604-875-2000aceocd@bcchr.ca

S. Evelyn Stewart, MD

604-875-2000estewart@ubc.ca

Locations

BC Children's Hospital Research Institute

Recruiting

Vancouver, British Columbia, Canada, V5Z4H4

Contacts

Principal Investigator:

S. Evelyn Stewart, MD

More Information

Sponsor

University of British Columbia

Last update posted

Dec 16, 2022

Last verified

Dec, 2022

Keywords

  • Non-steroidal anti-inflammatory drug
  • Cyclooxygenase inhibitor
  • Celecoxib
  • Inflammation
  • Children
  • Obsessive-compulsive disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2022-12-16.