Depression Clinical Trial
— MC-RWEOfficial title:
MC-RWE : Real World Evidence in Patient-Reported Outcomes for Medical Cannabis: A Prospective Observational Study
NCT number | NCT04526093 |
Other study ID # | 20-5537 |
Secondary ID | 16560 |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 15, 2020 |
Est. completion date | July 2023 |
This prospective observational study aims to describe the effectiveness of MC on pain, epilepsy, sleep and /or anxiety/depression in a cohorts of patients authorized to use MC, using pre-defined, validated self assessment scales.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | July 2023 |
Est. primary completion date | March 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: - Subjects (=19 years of age) who are MC-naïve or -experienced with a medical authorization for MC provided by a prescribing health care practitioner and who have provided informed consent - Primary therapeutic indications for MC use: pain, epilepsy, sleep, and/or anxiety/depression. - Subjects agree to use TruTrace™ verified products and refrain from using any other cannabis products, either medical or recreational, during the duration of the study Exclusion Criteria: - Concomitant use of illicit drugs - Concomitant use of recreational cannabis |
Country | Name | City | State |
---|---|---|---|
Canada | Toronto General Hospital, UHN | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | integrated medhealth communication, Shoppers Drug Mart |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The proportion of patients who have reported adverse effects due to MC use, as well as an assessment of the adverse effects based on different doses and methods of consumption. | A customized cannabis use questionnaire will be administered to collect information on side effects, dosage, and product types. | 6,12, 18 (if applicable) and 24 weeks after study initiation | |
Other | The proportion of patients who discontinued using MC during the course of the study as well the evaluation of the various reasons for this. | A customized cannabis use questionnaire will be administered to collect relevant information (i.e., when and why participants stopped using medical cannabis products, and if there is any leftover product, what they intended to do with it). | 6,12, 18 (if applicable) and 24 weeks after study initiation | |
Primary | Change in pain intensity from baseline to week 24 post-authorization of MC: Measured using the numerical rating scale (NRS). | The 11-point NRS ranges from '0' being no pain to '10'' being the worst pain imaginable.
Higher pain scores indicate greater pain intensity. |
Baseline, 6, 12, 18 (if applicable) and 24 weeks | |
Primary | Change in pain interference from baseline to week 24 post-authorization of MC: Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)-Pain Interference short form 6a. | The PROMIS-short form 6a measures six items on 5-point scales (1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit and 5=very much) for pain interference on aspects of daily life. Scores are calculated from the total of item responses, with higher scores reflecting greater pain interference. | Baseline, 6, 12, 18 (if applicable) and 24 weeks | |
Primary | Sleep: Change in the Pittsburgh Sleep Quality Index (PSQI) from baseline to week 24 post-authorization of MC | The PSQI contains 19-self rated questions and 5-questions rated by the roommate or bed partner. The 19 self-rated questions are combined to form seven component scores, each of which has a range of 0-3 points (0=no difficulty to 3=severe difficulty). Higher scores indicate worse sleep quality. | Baseline, 6, 12, 18 (if applicable) and 24 weeks | |
Primary | Anxiety: Change in the symptoms from baseline to week 24 post-authorization of MC; Measured using Generalized Anxiety Disorder 7-item scale (GAD-7). | This 7-item scale assesses the signs of GAD (e.g. ''Feeling afraid as if something awful might happen") with response option of : 0= Not at all, 1=Several days, 2= More than half the days and 3= Nearly everyday. Scores are calculated from the total of item responses, with higher scores reflecting greater anxiety. | Baseline, 6, 12, 18 (if applicable) and 24 weeks | |
Primary | Depression: Change in the symptoms from baseline to week 24 post-authorization of MC. Measured by Patient Health Questionnaire 9 item scale (PHQ-9). | The PHQ-9 assesses the signs of depression (e.g. Little interest or pleasure in doing things) with response option of : 0= Not at all, 1= Several days, 2= More than half the days, 3= Nearly everyday. Scores are calculated from the total of item responses, with higher scores reflecting the severity of depression. | Baseline, 6, 12, 18 (if applicable) and 24 weeks | |
Primary | Change in quality of life from baseline to Week 24: Measured using EuroQuol-5D-3-level health questionnaires(EQ-5D-3L) assessment scale. | The EQ-5D-3L assesses health state in each of 5 domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) on 3-point scale (no problems, some problems, extreme problems). Patients also rate their health on a vertical visual analogue scale with the endpoints "The best health you can imagine" and "The worse health you can imagine". | Baseline, 6, 12, 18 (if applicable) and 24 weeks | |
Primary | Epilepsy: change in seizure frequency for multiple different seizure types from baseline to Week 24 | Seizure frequency will be documented in a patient diary, and number of seizures of each seizure type in the preceding 6 weeks will be reported. | Baseline, 6, 12, 18 and 24 weeks | |
Secondary | Demographics | Describe the demographic of patients (e.g. age, gender) authorized for MC in Canada using customized questionnaire. | Baseline | |
Secondary | Clinical characteristics of patients | Describe the Clinical characteristics (e.g. comorbidities, concomitant medications, etc.) of patients authorized for MC in Canada using customized questionnaire. | Baseline | |
Secondary | Patient satisfaction with Medical Cannabis by Shoppers | The qualitative value of using the Medical cannabis by Shoppers platform and support services to the overall patient experience, as assessed by a customized questionnaire | 24 weeks after study initiation | |
Secondary | Changes in prescription medications of interest | Change in use of concomitant medications (e.g., opioids, anti-depressants, anxiolytics, high-dosage anti-inflammatories, antiepileptic drugs) over time on study, assessed by customized questionnaire. | 24 weeks after study initiation |
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