NCT03591224

Pharmacogenomic Testing to Optimize Antidepressant Drug Therapy

A Randomized Controlled Trial of Pharmacogenomic Guided Versus Standard Pharmacist Care to Optimize Antidepressant Drug Therapy in a Community Pharmacy Setting

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: John Papastergiou Pharmacy Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Depression
• Anxiety
• Major Depressive Disorder
• Generalized Anxiety Disorder
• Mood Disorders

Interventions

Type	Name	Description
OTHER	Pharmacogenomic Testing	pharmacogenomic drug response test provides personalized insights on a patient's predicted response to medications based on metabolism
OTHER	Pharmacist Standard of Care	Pharmacist providing standard of care as per usual practice

Timeline

• Start date: 2018-04-17
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2018-07-19
• Last updated: 2020-07-07

Locations

2 sites across 1 country: Canada