Obsessive-Compulsive Disorder Clinical Trial
— ACE-OCDOfficial 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
NCT number | NCT04673578 |
Other study ID # | H19-03886 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 1, 2021 |
Est. completion date | June 2023 |
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | June 2023 |
Est. primary completion date | June 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | BC Children's Hospital Research Institute | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | BC Children's Hospital Research Institute, Obsessive Compulsive Foundation |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 6 weeks (adjusted for baseline severity) | |
Secondary | 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). |
6 weeks, 12 weeks | |
Secondary | 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. | 6 weeks, 12 weeks | |
Secondary | 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). | 6 weeks, 12 weeks (adjusted for baseline) | |
Secondary | 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). | 6 weeks, 12 weeks (adjusted for baseline) | |
Secondary | 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). | 0-12 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04934007 -
Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder
|
N/A | |
Recruiting |
NCT04071990 -
Family Involvement in CBGT of OCD: a Randomized Controlled Trial
|
N/A | |
Completed |
NCT02541968 -
Internet-based vs Face-to-face Cognitive Behavioural Therapy for Obsessive-compulsive Disorder
|
N/A | |
Recruiting |
NCT05651295 -
A Precision Medicine Approach to Target Engagement for Emotion Regulation
|
N/A | |
Recruiting |
NCT05391503 -
Light Therapy for Obsessive-compulsive Disorder (OCD)
|
N/A | |
Recruiting |
NCT04539951 -
Pragmatic Trial of Obsessive-compulsive Disorder
|
Phase 2 | |
Completed |
NCT03416504 -
Methods for Managing Intrusive Thoughts
|
N/A | |
Not yet recruiting |
NCT06029738 -
Effect on Obsessive-Compulsive Beliefs and Symptoms of MCT-OCD
|
N/A | |
Recruiting |
NCT02844049 -
European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS
|
N/A | |
Completed |
NCT02911324 -
Cannabinoid Medication for Adults With OCD
|
Phase 1/Phase 2 | |
Terminated |
NCT02909660 -
What Are You Looking for? Psychometric and Experimental Analyses of Reassurance Seeking in Obsessive-compulsive Disorder
|
N/A | |
Completed |
NCT02217995 -
Mindfulness-Based Cognitive Therapy in a Clinical Sample of OCD Patients
|
N/A | |
Terminated |
NCT02234011 -
A Trial of Intranasal Ketamine for the Treatment of Obsessive-Compulsive Disorder
|
Phase 2 | |
Withdrawn |
NCT01953042 -
Benefits of a Psychoeducation Program for Those Awaiting Treatment for OCD and OCD Spectrum Disorders
|
N/A | |
Completed |
NCT02655926 -
Deep Brain Stimulation for Severe Obsessive Compulsive Disorder
|
N/A | |
Completed |
NCT00742664 -
Behavioral Treatment of Obsessive-Compulsive Symptoms in Youth With Prader-Willi Syndrome: A Pilot Project
|
Phase 1/Phase 2 | |
Completed |
NCT04919785 -
Deep Brain Stimulation in Severe Obsessive-compulsive Disorder
|
N/A | |
Terminated |
NCT00758966 -
Naltrexone SR and Fluoxetine Combination Therapy in Subjects With Obsessive-Compulsive Disorder
|
Phase 2 | |
Completed |
NCT00523718 -
Riluzole Augmentation in Treatment-refractory Obsessive-compulsive Disorder
|
Phase 2 | |
Completed |
NCT00074815 -
Treatment of Obsessive Compulsive Disorder in Children
|
Phase 3 |