Obsessive-Compulsive DisorderPhase 2ACE-OCDNCT04673578
Adjunctive Celecoxib in Childhood-onset OCD Study
A Phase 2 study testing Celecoxib in people with Obsessive-Compulsive Disorder and Pediatric Psychiatric Disorder, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Obsessive-Compulsive Disorder, Pediatric Psychiatric Disorder
- What is being tested?
- Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2021to Jun 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 18Show fewer
- 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
- Participant/parents unable to provide informed consent or assent or participate in self-care, AE 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
BC Children's Hospital Research Institute
Vancouver, British Columbia, V5Z4H4
Zainab Naqqash, BA, 6048752000 ext. 3068, zainab.naqqash@bcchr.ca
S. Evelyn Stewart, MD
About this study
Official title: Celecoxib Versus Placebo as an Adjunct to Treatment-as-usual in Children and Youth With Obsessive-compulsive Disorder: A Single-site Randomized Quadruple-blind Phase II Study
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.
Read the detailed description
Cyclooxygenase (COX) enzymes oxidize arachidonic acid to prostaglandins, which modulate normal neuronal function and inflammatory responses in the central nervous system. COX-2, which is constitutively expressed by glutamatergic neurons in the cortex, hippocampus, and amygdala, plays an important physiological role in synaptic plasticity and long-term potentiation. Pre-clinical studies point to a potential role for non-steroidal anti-inflammatory drugs (NSAIDs), which inhibit COX enzymes, in modulation of mood and anxiety symptoms. Recent meta-analyses also suggest a role for adjunctive COX inhibitors in the treatment of depression and first-episode schizophrenia. While consensus guidelines on the use of anti-inflammatory therapy in children with acute-onset subtypes of childhood-onset obsessive compulsive disorder (OCD) suggest NSAIDs as a first-line option for patients with mild impairment, there is limited empirical evidence to support their use in this population. Two small randomized-controlled trials in adults with OCD demonstrated improved symptom severity with celecoxib - a selective COX-2 inhibitor - raising the possibility that COX inhibition may be effective in a general OCD population.
The primary objective of this study is to compare the effects of celecoxib and placebo as adjuncts to treatment-as-usual on reduction in symptom severity, as determined by Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) after 12 weeks in children and youth with moderate-to-severe OCD.
This is a randomized, controlled, single-centre superiority trial with two parallel groups (celecoxib 50 mg [≤25 kg] or 100 mg [>25 kg] twice daily and placebo). Participants will be recruited from the BC Children's Hospital (BCCH) Provincial OCD Program and based on self-referral from community practices. Randomization will be performed as block randomization with a 1:1 allocation and stratified based on pre-treatment symptom severity. The investigator, outcomes assessor, clinician, and patient will be blinded to the intervention groups. Labs at baseline and 12 weeks will include complete blood count (CBC) with differential, creatinine, electrolytes, liver enzymes, and CRP. Participants will be assessed for OCD severity and adverse events at weeks 6 and 12. Analysis will be carried out according to intention-to-treat principles. Power calculations using estimates based on previous studies suggest a target recruitment of 80 participants. Participants will be offered a 12-week open-label celecoxib extension following the blinded phase for further assessment of tolerability.
The primary outcome is OCD severity (as measured by total CY-BOCS score) after 12 weeks in the celecoxib compared to placebo arm, adjusted for baseline. Secondary outcomes include CY-BOCS score after 6 weeks adjusted for baseline OCD severity, difference in the proportion of participants achieving a clinically meaningful response or remission; mean clinical global impression of severity and improvement after 6 and 12 weeks; and difference between celecoxib and placebo arms in the proportion of participants reporting adverse events that are possibly, probably, or definitely related to the study intervention.
NSAIDs are common in clinical practice and referenced in both adult and pediatric treatment guidelines for OCD, but no controlled studies have evaluated the effects of COX inhibitors in childhood-onset OCD. This study will be the first to assess the efficacy and safety of adjunctive celecoxib in this population and will inform clinical management of children and youth with OCD.
- Being tested
- Celecoxib, Placebo
- Keywords
- Non-steroidal anti-inflammatory drug, Cyclooxygenase inhibitor, Celecoxib, Inflammation, Children, Obsessive-compulsive disorder
- Medical subject headings
- Obsessive-Compulsive Disorder, Neurodevelopmental Disorders, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Also called MINT-CELECOXIB, NDC Code: 0025-1525, ATC Code: M01AH01, Canadian DIN: 02412497
Selective COX-2 inhibitor; nonsteroidal anti-inflammatory drug (NSAID)
PlaceboOther
Microcrystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks (adjusted for baseline severity)
Secondary outcomes (6)
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.
Measured: 6 weeks (adjusted for baseline severity)
Proportion of participants achieving a clinically meaningful treatment response.
Defined as a 25% reduction in the Children's Yale-Brown Obsessive-Compulsive Scale, 1st Edition (CY-BOCS-I) score or Clinical Global Impression of Improvement (CGI-I) of 1 or 2. As described for the primary outcome measure, this scale has a total score ranging from 0 to 40 with higher scores indicating greater symptom severity.
The CGI scales includes single item, clinician-rated, Likert-type scales of severity and improvement. The CGI-S (severity) is a frequently-used measure for assessment of symptom severity across multiple psychiatric illnesses due to its face validity and ease of clinical use. Responses range from 1 (no symptoms) through 7 (among the most severely ill patients, extremely severe symptoms, or completely non-functional). The CGI-I (improvement) typically but not always tracks with CGI-S and has been used previously to define response in treatment trials of pediatric OCD. CGI-I scores range from 1 (very much improved) through to 7 (very much worse).
Measured: 6 weeks, 12 weeks
Proportion of participants achieving clinical remission.
Defined based on Children's Yale-Brown Obsessive-Compulsive Scale, 1st Edition (CY-BOCS-I) ≤ 14. As described for the primary outcome measure, this scale has a total score ranging from 0 to 40 with higher scores indicating greater symptom severity.
Measured: 6 weeks, 12 weeks
Mean Clinical Global Impression of Severity (CGI-S)
As described in Outcome 3, the CGI-S is a 7-point clinician-rated Likert scale with scores ranging from 1 (no OCD symptoms) through 7 (among the most severely ill patients, extremely severe symptoms, or completely non-functional).
Measured: 6 weeks, 12 weeks (adjusted for baseline)
Mean Clinician Global Impression of Improvement (CGI-I)
As described in Outcome 3, the CGI-I is a 7-point clinician-rated Likert scale with scores ranging from 1 (very much improved) through to 7 (very much worse).
Measured: 6 weeks, 12 weeks (adjusted for baseline)
Proportion of participants reporting adverse events that are possibly, probably, or definitely related to the study intervention.
Adverse events will be monitored by clinician interview in addition to a questionnaire adapted from the Safety Monitoring Uniform Research Form (SMURF).
Measured: 0-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Jun 2021
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- BC Children's Hospital Research Institute, Obsessive Compulsive Foundation
- Responsible party
- Principal investigator, Evelyn Stewart, MD, University of British Columbia
- Investigators
- S. Evelyn Stewart, MD, Principal investigator, University of British Columbia; BC Children's Hospital Research InstituteClara Westwell-Roper, MD, PhD, Study chair, University of British Columbia; BC Children's Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673578
- Sponsor's protocol ID
- H19-03886
- Acronym
- ACE-OCD
- Status last verified
- Dec 2022
- First submitted
- 24 Nov 2020
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35105633
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Celecoxib Versus Placebo as an Adjunct to Treatment-as-usual in Children and Youth With Obsessive-compulsive Disorder: A Single-site Randomized Quadruple-blind Phase II Study
- ClinicalTrials.gov ID
- NCT04673578
- Acronym / sponsor ID
- ACE-OCD / H19-03886
- Keywords
- Non-steroidal anti-inflammatory drug, Cyclooxygenase inhibitor, Celecoxib, Inflammation, Children, Obsessive-compulsive disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- BC Children's Hospital Research Institute, Obsessive Compulsive Foundation
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cyclooxygenase (COX) enzymes oxidize arachidonic acid to prostaglandins, which modulate normal neuronal function and inflammatory responses in the central nervous system. COX-2, which is constitutively expressed by glutamatergic neurons in the cortex, hippocampus, and amygdala, plays an important physiological role in synaptic plasticity and long-term potentiation. Pre-clinical studies point to a potential role for non-steroidal anti-inflammatory drugs (NSAIDs), which inhibit COX enzymes, in modulation of mood and anxiety symptoms. Recent meta-analyses also suggest a role for adjunctive COX inhibitors in the treatment of depression and first-episode schizophrenia. While consensus guidelines on the use of anti-inflammatory therapy in children with acute-onset subtypes of childhood-onset obsessive compulsive disorder (OCD) suggest NSAIDs as a first-line option for patients with mild impairment, there is limited empirical evidence to support their use in this population. Two small randomized-controlled trials in adults with OCD demonstrated improved symptom severity with celecoxib - a selective COX-2 inhibitor - raising the possibility that COX inhibition may be effective in a general OCD population.
The primary objective of this study is to compare the effects of celecoxib and placebo as adjuncts to treatment-as-usual on reduction in symptom severity, as determined by Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) after 12 weeks in children and youth with moderate-to-severe OCD.
This is a randomized, controlled, single-centre superiority trial with two parallel groups (celecoxib 50 mg [≤25 kg] or 100 mg [>25 kg] twice daily and placebo). Participants will be recruited from the BC Children's Hospital (BCCH) Provincial OCD Program and based on self-referral from community practices. Randomization will be performed as block randomization with a 1:1 allocation and stratified based on pre-treatment symptom severity. The investigator, outcomes assessor, clinician, and patient will be blinded to the intervention groups. Labs at baseline and 12 weeks will include complete blood count (CBC) with differential, creatinine, electrolytes, liver enzymes, and CRP. Participants will be assessed for OCD severity and adverse events at weeks 6 and 12. Analysis will be carried out according to intention-to-treat principles. Power calculations using estimates based on previous studies suggest a target recruitment of 80 participants. Participants will be offered a 12-week open-label celecoxib extension following the blinded phase for further assessment of tolerability.
The primary outcome is OCD severity (as measured by total CY-BOCS score) after 12 weeks in the celecoxib compared to placebo arm, adjusted for baseline. Secondary outcomes include CY-BOCS score after 6 weeks adjusted for baseline OCD severity, difference in the proportion of participants achieving a clinically meaningful response or remission; mean clinical global impression of severity and improvement after 6 and 12 weeks; and difference between celecoxib and placebo arms in the proportion of participants reporting adverse events that are possibly, probably, or definitely related to the study intervention.
NSAIDs are common in clinical practice and referenced in both adult and pediatric treatment guidelines for OCD, but no controlled studies have evaluated the effects of COX inhibitors in childhood-onset OCD. This study will be the first to assess the efficacy and safety of adjunctive celecoxib in this population and will inform clinical management of children and youth with OCD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Celecoxib | Experimental | Drug: CelecoxibCelecoxib 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 (microcrystalline cellulose) | Placebo comparator | Other: PlaceboPlacebo capsules identical to celecoxib. One capsule orally twice daily for 12 weeks. Used as adjunct to treatment-as-usual. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CelecoxibAlso: MINT-CELECOXIB, NDC Code: 0025-1525, ATC Code: M01AH01, Canadian DIN: 02412497Selective COX-2 inhibitor; nonsteroidal anti-inflammatory drug (NSAID) | Drug | Celecoxib |
| PlaceboMicrocrystalline cellulose | Other | Placebo (microcrystalline cellulose) |
Primary outcome
Children's Yale-Brown Obsessive-Compulsive Scale, 1st Edition (CY-BOCS-I)
Time frame: 12 weeks (adjusted for baseline severity)
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.
6 secondary outcomes
Children's Yale-Brown Obsessive-Compulsive Scale, 1st Edition (CY-BOCS-I)
Time frame: 6 weeks (adjusted for baseline severity)
Proportion of participants achieving a clinically meaningful treatment response.
Time frame: 6 weeks, 12 weeks
Proportion of participants achieving clinical remission.
Time frame: 6 weeks, 12 weeks
Mean Clinical Global Impression of Severity (CGI-S)
Time frame: 6 weeks, 12 weeks (adjusted for baseline)
Mean Clinician Global Impression of Improvement (CGI-I)
Time frame: 6 weeks, 12 weeks (adjusted for baseline)
Proportion of participants reporting adverse events that are possibly, probably, or definitely related to the study intervention.
Time frame: 0-12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Derived from this study: PubMed 35105633Westwell-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.
- Individual participant dataSharing planned: No
Related trials for Obsessive-Compulsive Disorder
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
Not yet recruiting
Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Treatment-refractory Obsessive-compulsive Disorder (trOCD)
Recruiting
tDCS Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive Disorder
Obsessive-Compulsive Disorder
Recruiting
Mindfulness Intervention for Psychological and Family Dynamics in Children With Body-Focused Repetitive Behaviors
Mindfulness Skills, Psychosocial Education
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
S. Evelyn Stewart, MD principal investigator
University of British Columbia; BC Children's Hospital Research Institute
Clara Westwell-Roper, MD, PhD study chair
University of British Columbia; BC Children's Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celecoxib in people with Obsessive-Compulsive Disorder and Pediatric Psychiatric Disorder, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Research Assistant, Provincial OCD Program (604-875-2000 ext. 3068, aceocd@bcchr.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Yale-Brown Obsessive-Compulsive Scale, 1st Edition (CY-BOCS-I) (time frame: 12 weeks (adjusted for baseline severity)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04673578, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.