Clinical trial NCT03591224: Pharmacogenomic Testing to Optimize Antidepressant Drug Therapy
Official title: A Randomized Controlled Trial of Pharmacogenomic Guided Versus Standard Pharmacist Care to Optimize Antidepressant Drug Therapy in a Community Pharmacy Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Major Depressive Disorder
Generalized Anxiety Disorder
Mood Disorders
Keywords: pharmacogenetics
pharmacogenomics
antidepressants
pharmacy
pharmacist
community
Lead sponsor: John Papastergiou Pharmacy Ltd
Sponsor class: INDUSTRY
Collaborators: name: Green Shield Canada
First posted: 2018-07-19
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

\[Q1. Side effects interfere with my physical activity, Q2. Side effects interfere with my leisure activities, Q3. Side effects interfere with my daily activities, Q4. The medicine I am taking reduces my symptoms, Q5. I am satisfied with the time it takes for the medicine to start to have an effect, Q6. I feel better now than I did before starting the treatment, Q7.I intend to continue using this treatment, Q8. I feel happy with my treatment, Q9. In general, I feel satisfied with the treatment.\]

Exclusion Criteria:

* 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

Primary outcomes:
measure: Treatment Satisfaction with Medicines Questionnaire (SATMED-Q) - general measure of satisfaction to drug therapy
timeFrame: Change of score from baseline to 6 months
measure: Patient Health Questionnaire (PHQ-9) - measure/monitor the severity of depression
timeFrame: Change of score from baseline to 6 months
measure: Generalized Anxiety Disorder-7 (GAD-7) - measure/monitor the severity of anxiety
timeFrame: Change of score from baseline to 6 months
measure: Sheehan Disability Scale - measure of functional impairment in work/school, social life, and family life
timeFrame: Change of score from baseline to 6 months
Secondary outcomes:
measure: Number of pharmacist identified drug therapy problems
timeFrame: Analysis done at the completion of study (~1 year)
measure: Prescriber acceptance rate of pharmacist's recommendations
timeFrame: Analysis done at the completion of study (~1 year)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: John Papastergiou Pharmacy Ltd - Store#500
state: Ontario
city: Toronto
country: Canada
facility: John Papastergiou Pharmacy Ltd - Store#994
state: Ontario
Study officials:
affiliation: University of Toronto
name: John Papastergiou, B.Sc.Phm
role: PRINCIPAL_INVESTIGATOR
affiliation: John Papastergiou Pharmacy Ltd
name: Wilson Li, B.Sc.Phm
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Papastergiou 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.