DepressionNCT03591224
Pharmacogenomic Testing to Optimize Antidepressant Drug Therapy
A study testing Pharmacogenomic Testing in people with Depression and Anxiety, run by John Papastergiou Pharmacy Ltd at 2 sites in Canada.
Trial summary
A randomized controlled trial comparing pharmacogenomic guided versus standard pharmacist care to optimize antidepressant drug therapy. This study evaluates the effectiveness of pharmacists utilizing pharmacogenomic testing in the community pharmacy setting to help patients find the most appropriate drug therapy… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Major Depressive Disorder
- What is being tested?
- Pharmacogenomic Testing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 213 participants
- Where
- 2 sitesCanada
- Study dates
- 17 Apr 2018to 31 Dec 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Prescribed one or more antidepressants
- Diagnosed with major depressive disorder and/or generalized anxiety disorder
- Newly initiated on antidepressant therapy or a recent change in therapy and dissatisfied with therapy.
- Experiencing adverse drug reaction(s) or suboptimal response or dissatisfaction with therapy
- Demonstrated dissatisfaction based on a 9-item prescreening questionnaire. Scoring range from 0='not at all' to 4='very much'. If any scores for Q1-3 on side effects >2, or if any scores for Q4-6 on effectiveness <2, or if any scores for Q7-9 on overall opinion of therapy <2.
- [Q1. Side effects interfere with my physical activity, Q2. Side effects interfere with my leisure activities, Q3. Side effects interfere with my daily activities, Q4. The medicine I am taking reduces my symptoms, Q5. I am satisfied with the time it takes for the medicine to start to have an effect, Q6. I feel better now than I did before starting the treatment, Q7.I intend to continue using this treatment, Q8. I feel happy with my treatment, Q9. In general, I feel satisfied with the treatment.]
Who cannot join
- Patients with poor command of English or who are unable to provide fully informed consent
- Liver transplant patient (cheek swab won't detect liver DNA)
- Non-adherent to prescribed drug therapy due to reasons outside of "not feeling better" (non-medical influencing factors)
- Diagnosis of schizophrenia, bipolar disorder, dementia
- Patients under 18 years old
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
John Papastergiou Pharmacy Ltd - Store#500
Toronto, Ontario, M4C 1H6
John Papastergiou Pharmacy Ltd - Store#994
Toronto, Ontario, M4J 1L2
About this study
Official title: A Randomized Controlled Trial of Pharmacogenomic Guided Versus Standard Pharmacist Care to Optimize Antidepressant Drug Therapy in a Community Pharmacy Setting
A randomized controlled trial comparing pharmacogenomic guided versus standard pharmacist care to optimize antidepressant drug therapy. This study evaluates the effectiveness of pharmacists utilizing pharmacogenomic testing in the community pharmacy setting to help patients find the most appropriate drug therapy option(s) and minimize the risk of side effects in collaboration with prescribing physicians.
Read the detailed description
Physicians and pharmacists have long been aware of subtle differences between patients in their responses to medications, but until recently did not have the tools to predict a patient's response to a drug before prescribing it. Many commonly prescribed medications are either ineffective or cause significant side effects for some patients. Individual variation in response to prescription drugs due to genetic factors (pharmacogenetics) is a substantial part of this serious clinical issue. Such variation in patient response ranges from failure to benefit from a drug, to adverse drug reactions, and drug-drug interactions when several drugs are taken at the same time. After years of uncertainty over the value of personalized medicine, recent studies show promising approaches for incorporating pharmacogenetics (PGx) data into routine patient care in order to reduce medication issues due to genetic factors.
Over the last decades, clinical PGx research has made significant progress in defining which genetic variations are important for influencing inter-patient variability in drug response. Evidence-based consensus therapeutic guidelines for multiple drug-gene pairs are available and promoted by the Clinical Pharmacogenetic Implementation Consortium (CPIC). Although the primary focus of PGx testing has been on improving drug selection and dosing, a secondary benefit of testing is the improvement of medication adherence.
GeneYouIn has developed the Pillcheck® drug response test that provides personalized insights on a patient's predicted response to medications. To implement the Pillcheck test, GeneYouIn is working with pharmacists who are adept in understanding pharmacogenetic terminology and can consult with prescribing physicians and patients within current scope of practice. GeneYouIn will provide educational seminars on the latest advances in pharmacogenetics and using the Pillcheck report.
This demonstration project will provide critical education to clinical pharmacists to enable utilization of patients' pharmacogenetic data for evidence-base treatment optimization. The Pillcheck report has been carefully designed to make it easy to interpret and integrate in the clinical pharmacy setting. The study will provide insights on the impact of pharmacogenetics testing on solving Drug Therapy Problems.
The Pillcheck test assesses variations in 14 genes responsible for drug transport and metabolism for over 140 commonly prescribed medications. The Pillcheck report can enable pharmacists to effectively identify Drug Therapy Problems and advise physicians on personalized treatment options thus allowing for more rational medication choices and/or dosing.
- Conditions
- Depression, Anxiety, Major Depressive Disorder, Generalized Anxiety Disorder, Mood Disorders
- Being tested
- Pharmacogenomic Testing, Pharmacist Standard of Care
- Keywords
- pharmacogenetics, pharmacogenomics, antidepressants, pharmacy, pharmacist, community
- Medical subject headings
- Depression, Anxiety Disorders, Depressive Disorder, Major, Generalized Anxiety Disorder, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenomic TestingOther
Also called Pillcheck, Geneyouin
pharmacogenomic drug response test provides personalized insights on a patient's predicted response to medications based on metabolism
Pharmacist Standard of CareOther
Pharmacist providing standard of care as per usual practice
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Pharmacist optimizing antidepressant therapy using the patient's personalized pharmacogenomic report to make recommendations. Receives: Other: Pharmacogenomic Testing |
| Control | Placebo comparator | Pharmacist optimizing antidepressant therapy based on standard of care Receives: Other: Pharmacist Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Satisfaction with Medicines Questionnaire (SATMED-Q) - general measure of satisfaction to drug therapy
This scale evaluates patient satisfaction of drug treatment for with any chronic disease. It's a brief, self-administer multidimensional generic questionnaire comprising 17 items. There are six categories of questions assessing satisfaction of (1) drug efficacy, (2) side-effects, (3) convenience of use, (4) medical care, (5) impact on activities of daily living and (6) general satisfaction. Scores of individual items range from 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much. A higher total score is an indication of greater satisfaction with drug therapy. Only scores from the side effects category would be summed as negative values. There is no recommended cutoff score, however is used to monitor the overall satisfaction to treatment over the period of the study.
Measured: Change of score from baseline to 6 months
Patient Health Questionnaire (PHQ-9) - measure/monitor the severity of depression
PHQ-9 is a clinical evidence-based scale used to assess the severity of depression. There are nine diagnostic criteria for major depression based on the Diagnostic and Statistical 4th Ed. (DSM-IV) which are scored '0' (not at all), '1' (several days),'2' more than half the days, '3' (nearly every day). The nine items cover experience of pleasure, feeling down, sleep disruption, energy levels, appetite, feeling a failure, trouble concentrating, speaking slowly or being fidgety and having negative thoughts around suicide or self-harm over the previous 2 weeks. The total sum indicates depression severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Measured: Change of score from baseline to 6 months
Generalized Anxiety Disorder-7 (GAD-7) - measure/monitor the severity of anxiety
Evidence-based questionnaire used to monitor the severity of generalized anxiety. The GAD-7 score is calculated by assigning scores of '0' (not at all), '1' (several days),'2' more than half the days, '3' (nearly every day). Questions assess the tendency of feeling nervous, not being able to stop or control worrying, worrying too much about different things, trouble relaxing, being so restless that it's hard to sit still, becoming easily annoyed or irritable, feeling afraid as if something awful might happen. Total sums of 5, 10, and 15 represent mild, moderate, and severe anxiety, respectively.
Measured: Change of score from baseline to 6 months
Sheehan Disability Scale - measure of functional impairment in work/school, social life, and family life
This scale assesses functional impairment using three 0 to 10 point visual analog scales. This can also be interpreted as percentages. Each of the three scales would have the patient represent how have their symptoms disrupted (1) work/school life, (2) social life, and (3) family life/responsibilities. The points from the 3 scales are summed as a global functional impairment score ranging from 0 (unimpaired) to 30 (highly impaired). There is no recommended cutoff score, however is used to monitor the response to treatment over the period of the study. In general, a score of 5 or greater on any of the three scales is associated with significant functional impairment.
Measured: Change of score from baseline to 6 months
Secondary outcomes (2)
Number of pharmacist identified drug therapy problems
Total number of Drug Therapy Problems related to antidepressant use identified by the pharmacist include the following types (1) Dose too high/overuse/abuse, (2) Dose too low, (3) Unnecessary drug therapy/duplication, (4) Adverse drug reaction / drug interaction, (5) Requires additional drug therapy, (6) Non-adherence, (7) Inappropriate drug for indication
Measured: Analysis done at the completion of study (~1 year)
Prescriber acceptance rate of pharmacist's recommendations
Percentage of prescriber accepted pharmacist recommendations in the intervention group vs. control group
Measured: Analysis done at the completion of study (~1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start17 Apr 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Enrolled subjects will be randomly assigned to either the control arm (pharmacist standard of care) or intervention arm (pharmacogenetic guided decision making by the pharmacist) in optimizing antidepressant drug therapy. Randomization is done by the primary investigator who isn't directly involved with patient consultations.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Papastergiou Pharmacy Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Green Shield Canada
- Responsible party
- Sponsor
- Investigators
- John Papastergiou, B.Sc.Phm, Principal investigator, University of TorontoWilson Li, B.Sc.Phm, Study director, John Papastergiou Pharmacy Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591224
- Sponsor's protocol ID
- Pro00025062
- Status last verified
- Jul 2020
- First submitted
- 25 Jun 2018
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rejas J, Ruiz MA, Pardo A, Soto J. Minimally important difference of the Treatment Satisfaction with Medicines Questionnaire (SATMED-Q). BMC Med Res Methodol. 2011 Oct 20;11:142. doi: 10.1186/1471-2288-11-142.
PubMed 22014277Papastergiou J, Quilty LC, Li W, Thiruchselvam T, Jain E, Gove P, Mandlsohn L, van den Bemt B, Pojskic N. Pharmacogenomics guided versus standard antidepressant treatment in a community pharmacy setting: A randomized controlled trial. Clin Transl Sci. 2021 Jul;14(4):1359-1368. doi: 10.1111/cts.12986. Epub 2021 Feb 28.
PubMed 33641259
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Pharmacogenomic Guided Versus Standard Pharmacist Care to Optimize Antidepressant Drug Therapy in a Community Pharmacy Setting
- ClinicalTrials.gov ID
- NCT03591224
- Acronym / sponsor ID
- Pro00025062
- Conditions
- Depression, Anxiety, Major Depressive Disorder, Generalized Anxiety Disorder, Mood Disorders
- Keywords
- pharmacogenetics, pharmacogenomics, antidepressants, pharmacy, pharmacist, community
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- John Papastergiou Pharmacy LtdIndustry (pharma, biotech, devices)
- Collaborators
- Green Shield Canada
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 Jul 2018 (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.
A randomized controlled trial comparing pharmacogenomic guided versus standard pharmacist care to optimize antidepressant drug therapy. This study evaluates the effectiveness of pharmacists utilizing pharmacogenomic testing in the community pharmacy setting to help patients find the most appropriate drug therapy option(s) and minimize the risk of side effects in collaboration with prescribing physicians.
Detailed description
Physicians and pharmacists have long been aware of subtle differences between patients in their responses to medications, but until recently did not have the tools to predict a patient's response to a drug before prescribing it. Many commonly prescribed medications are either ineffective or cause significant side effects for some patients. Individual variation in response to prescription drugs due to genetic factors (pharmacogenetics) is a substantial part of this serious clinical issue. Such variation in patient response ranges from failure to benefit from a drug, to adverse drug reactions, and drug-drug interactions when several drugs are taken at the same time. After years of uncertainty over the value of personalized medicine, recent studies show promising approaches for incorporating pharmacogenetics (PGx) data into routine patient care in order to reduce medication issues due to genetic factors.
Over the last decades, clinical PGx research has made significant progress in defining which genetic variations are important for influencing inter-patient variability in drug response. Evidence-based consensus therapeutic guidelines for multiple drug-gene pairs are available and promoted by the Clinical Pharmacogenetic Implementation Consortium (CPIC). Although the primary focus of PGx testing has been on improving drug selection and dosing, a secondary benefit of testing is the improvement of medication adherence.
GeneYouIn has developed the Pillcheck® drug response test that provides personalized insights on a patient's predicted response to medications. To implement the Pillcheck test, GeneYouIn is working with pharmacists who are adept in understanding pharmacogenetic terminology and can consult with prescribing physicians and patients within current scope of practice. GeneYouIn will provide educational seminars on the latest advances in pharmacogenetics and using the Pillcheck report.
This demonstration project will provide critical education to clinical pharmacists to enable utilization of patients' pharmacogenetic data for evidence-base treatment optimization. The Pillcheck report has been carefully designed to make it easy to interpret and integrate in the clinical pharmacy setting. The study will provide insights on the impact of pharmacogenetics testing on solving Drug Therapy Problems.
The Pillcheck test assesses variations in 14 genes responsible for drug transport and metabolism for over 140 commonly prescribed medications. The Pillcheck report can enable pharmacists to effectively identify Drug Therapy Problems and advise physicians on personalized treatment options thus allowing for more rational medication choices and/or dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Enrolled subjects will be randomly assigned to either the control arm (pharmacist standard of care) or intervention arm (pharmacogenetic guided decision making by the pharmacist) in optimizing antidepressant drug therapy. Randomization is done by the primary investigator who isn't directly involved with patient consultations.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Pharmacogenomic TestingPharmacist optimizing antidepressant therapy using the patient's personalized pharmacogenomic report to make recommendations. |
| Control | Placebo comparator | Other: Pharmacist Standard of CarePharmacist optimizing antidepressant therapy based on standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Prescribed one or more antidepressants
- Diagnosed with major depressive disorder and/or generalized anxiety disorder
- Newly initiated on antidepressant therapy or a recent change in therapy and dissatisfied with therapy.
- Experiencing adverse drug reaction(s) or suboptimal response or dissatisfaction with therapy
- Demonstrated dissatisfaction based on a 9-item prescreening questionnaire. Scoring range from 0='not at all' to 4='very much'. If any scores for Q1-3 on side effects >2, or if any scores for Q4-6 on effectiveness <2, or if any scores for Q7-9 on overall opinion of therapy <2.
Key exclusion criteria (5 listed)
- Patients with poor command of English or who are unable to provide fully informed consent
- Liver transplant patient (cheek swab won't detect liver DNA)
- Non-adherent to prescribed drug therapy due to reasons outside of "not feeling better" (non-medical influencing factors)
- Diagnosis of schizophrenia, bipolar disorder, dementia
- Patients under 18 years old
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 |
|---|---|---|
| Pharmacogenomic TestingAlso: Pillcheck, Geneyouinpharmacogenomic drug response test provides personalized insights on a patient's predicted response to medications based on metabolism | Other | Intervention |
| Pharmacist Standard of CarePharmacist providing standard of care as per usual practice | Other | Control |
Primary outcome
Treatment Satisfaction with Medicines Questionnaire (SATMED-Q) - general measure of satisfaction to drug therapy
Time frame: Change of score from baseline to 6 months
This scale evaluates patient satisfaction of drug treatment for with any chronic disease. It's a brief, self-administer multidimensional generic questionnaire comprising 17 items. There are six categories of questions assessing satisfaction of (1) drug efficacy, (2) side-effects, (3) convenience of use, (4) medical care, (5) impact on activities of daily living and (6) general satisfaction. Scores of individual items range from 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much. A higher total score is an indication of greater satisfaction with drug therapy. Only scores from the side effects category would be summed as negative values. There is no recommended cutoff score, however is used to monitor the overall satisfaction to treatment over the period of the study.
Patient Health Questionnaire (PHQ-9) - measure/monitor the severity of depression
Time frame: Change of score from baseline to 6 months
PHQ-9 is a clinical evidence-based scale used to assess the severity of depression. There are nine diagnostic criteria for major depression based on the Diagnostic and Statistical 4th Ed. (DSM-IV) which are scored '0' (not at all), '1' (several days),'2' more than half the days, '3' (nearly every day). The nine items cover experience of pleasure, feeling down, sleep disruption, energy levels, appetite, feeling a failure, trouble concentrating, speaking slowly or being fidgety and having negative thoughts around suicide or self-harm over the previous 2 weeks. The total sum indicates depression severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Generalized Anxiety Disorder-7 (GAD-7) - measure/monitor the severity of anxiety
Time frame: Change of score from baseline to 6 months
Evidence-based questionnaire used to monitor the severity of generalized anxiety. The GAD-7 score is calculated by assigning scores of '0' (not at all), '1' (several days),'2' more than half the days, '3' (nearly every day). Questions assess the tendency of feeling nervous, not being able to stop or control worrying, worrying too much about different things, trouble relaxing, being so restless that it's hard to sit still, becoming easily annoyed or irritable, feeling afraid as if something awful might happen. Total sums of 5, 10, and 15 represent mild, moderate, and severe anxiety, respectively.
Sheehan Disability Scale - measure of functional impairment in work/school, social life, and family life
Time frame: Change of score from baseline to 6 months
This scale assesses functional impairment using three 0 to 10 point visual analog scales. This can also be interpreted as percentages. Each of the three scales would have the patient represent how have their symptoms disrupted (1) work/school life, (2) social life, and (3) family life/responsibilities. The points from the 3 scales are summed as a global functional impairment score ranging from 0 (unimpaired) to 30 (highly impaired). There is no recommended cutoff score, however is used to monitor the response to treatment over the period of the study. In general, a score of 5 or greater on any of the three scales is associated with significant functional impairment.
2 secondary outcomes
Number of pharmacist identified drug therapy problems
Time frame: Analysis done at the completion of study (~1 year)
Prescriber acceptance rate of pharmacist's recommendations
Time frame: Analysis done at the completion of study (~1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Background: PubMed 22014277Rejas J, Ruiz MA, Pardo A, Soto J. Minimally important difference of the Treatment Satisfaction with Medicines Questionnaire (SATMED-Q). BMC Med Res Methodol. 2011 Oct 20;11:142. doi: 10.1186/1471-2288-11-142.
- Derived from this study: PubMed 33641259Papastergiou J, Quilty LC, Li W, Thiruchselvam T, Jain E, Gove P, Mandlsohn L, van den Bemt B, Pojskic N. Pharmacogenomics guided versus standard antidepressant treatment in a community pharmacy setting: A randomized controlled trial. Clin Transl Sci. 2021 Jul;14(4):1359-1368. doi: 10.1111/cts.12986. Epub 2021 Feb 28.
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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.
John Papastergiou, B.Sc.Phm principal investigator
University of Toronto
Wilson Li, B.Sc.Phm study director
John Papastergiou Pharmacy Ltd
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacogenomic Testing in people with Depression and Anxiety, run by John Papastergiou Pharmacy Ltd at 2 sites 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Satisfaction with Medicines Questionnaire (SATMED-Q) - general measure of satisfaction to drug therapy (time frame: Change of score from baseline to 6 months). The study lists 4 primary outcomes in all. 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 NCT03591224, which also lists 2 linked publications.
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 7 Jul 2020.