Adjunctive Celecoxib in Childhood-onset OCD Study

NCT04673578 | Unknown Phase 2 DMC

• 1 other identifier: H19-03886
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Children's Yale-Brown Obsessive-Compulsive Scale, 1st Edition (CY-BOCS-I)

  The CY-BOCS is a well-validated clinician-rated measure to assess obsessive-compulsive symptom severity. This results in two subscale total scores, Obsessions and Compulsions, each ranging from 0-20, with a higher score indicating greater symptom severity. These subscale scores are summed to provide a total score, ranging from 0 to 40, that is used to measure overall OCD symptom severity.

  12 weeks (adjusted for baseline severity)

Secondary Outcomes (6)

• Children's Yale-Brown Obsessive-Compulsive Scale, 1st Edition (CY-BOCS-I)

  6 weeks (adjusted for baseline severity)

• Proportion of participants achieving a clinically meaningful treatment response.

  6 weeks, 12 weeks

• Proportion of participants achieving clinical remission.

  6 weeks, 12 weeks

• Mean Clinical Global Impression of Severity (CGI-S)

  6 weeks, 12 weeks (adjusted for baseline)

• Mean Clinician Global Impression of Improvement (CGI-I)

  6 weeks, 12 weeks (adjusted for baseline)

Study Arms (2)

Celecoxib

EXPERIMENTAL

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.

Drug: Celecoxib

Placebo (microcrystalline cellulose)

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Celecoxib DRUG

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

Also known as: MINT-CELECOXIB, NDC Code: 0025-1525, ATC Code: M01AH01, Canadian DIN: 02412497

Celecoxib

Placebo OTHER

Microcrystalline cellulose

Placebo (microcrystalline cellulose)

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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 (i.e. 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 (ALT, ALP, or AST \> 1.5x upper limit of normal)
• 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
• Changes in 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 physician (family doctor or specialist) providing usual medical care

Sponsors & Collaborators

• University of British Columbia: lead
• BC Children's Hospital Research Institute: collaborator
• Obsessive Compulsive Foundation: collaborator

Study Sites (1)

BC Children's Hospital Research Institute

Vancouver, British Columbia, V5Z4H4, Canada

RECRUITING

Related Publications (1)

• Westwell-Roper C, Best JR, Elbe D, MacFadden M, Baer S, Tucker L, Au A, Naqqash Z, Lin B, Lu C, Stewart SE. Celecoxib versus placebo as an adjunct to treatment-as-usual in children and youth with obsessive-compulsive disorder: protocol for a single-site randomised quadruple-blind phase II study. BMJ Open. 2022 Jan 31;12(1):e054296. doi: 10.1136/bmjopen-2021-054296.

  PMID: 35105633 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Neurodevelopmental Disorders; Inflammation

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• S. Evelyn Stewart, MD

  University of British Columbia; BC Children's Hospital Research Institute

  PRINCIPAL INVESTIGATOR

• Clara Westwell-Roper, MD, PhD

  University of British Columbia; BC Children's Hospital Research Institute

  STUDY CHAIR

Central Study Contacts

Research Assistant, Provincial OCD Program

CONTACT

604-875-2000; aceocd@bcchr.ca

S. Evelyn Stewart, MD

CONTACT

604-875-2000; estewart@ubc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo capsules will be dispensed similar in appearance to celecoxib capsules. Unique randomization codes will be used for each participant to avoid inadvertent loss of blinding for all participants in the event that one is unblinded. Data analysis and manuscript writing will be performed after unblinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Division of Clinical & Behavioural Neurosciences, Department of Psychiatry, Faculty of Medicine; Medical Director, BCCH Provincial OCD Program (POP); Investigator, BC Children's Hospital

Model Details: Participants will be randomly assigned to celecoxib or placebo arms. Participants will have the option of participating in a 12-week open-label celecoxib extension after completing the randomized portion of the study.

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 17, 2020
• Study Start: June 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: December 16, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)