Pharmacogenomic Testing to Optimize Antidepressant Drug Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03591224|
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : July 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Depression Anxiety Major Depressive Disorder Generalized Anxiety Disorder Mood Disorders||Other: Pharmacogenomic Testing Other: Pharmacist Standard of Care||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||Double (Participant, Care Provider)|
|Masking Description:||Patients are not told of their group assignment until the end of the study, at which point they would receive a copy of their pharmacogenetic report. The consulting pharmacist also does not have knowledge of the patient's group assignment in the first encounter for baseline data collection. Group assignment is only revealed to the pharmacist after two weeks when the pharmacogenetic report is available on the Pillcheck online portal. Patients assigned to the control group will have their report appear blank to the pharmacist, whereas the intervention patient group will have their full pharmacogenetic report accessible by the consulting pharmacist. Prescribers are also informed via fax briefly of the study protocol and asked to maintain blinding of their patient's group assignment.|
|Official Title:||A Randomized Controlled Trial of Pharmacogenomic Guided Versus Standard Pharmacist Care to Optimize Antidepressant Drug Therapy in a Community Pharmacy Setting|
|Actual Study Start Date :||April 17, 2018|
|Estimated Primary Completion Date :||April 17, 2019|
|Estimated Study Completion Date :||April 17, 2019|
Active Comparator: Intervention
Pharmacist optimizing antidepressant therapy using the patient's personalized pharmacogenomic report to make recommendations.
Other: Pharmacogenomic Testing
pharmacogenomic drug response test provides personalized insights on a patient's predicted response to medications based on metabolism
Placebo Comparator: Control
Pharmacist optimizing antidepressant therapy based on standard of care
Other: Pharmacist Standard of Care
Pharmacist providing standard of care as per usual practice
- 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.
- Number of pharmacist identified drug therapy problems [ Time Frame: Analysis done at the completion of study (~1 year) ]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
- Prescriber acceptance rate of pharmacist's recommendations [ Time Frame: Analysis done at the completion of study (~1 year) ]Percentage of prescriber accepted pharmacist recommendations in the intervention group vs. control group
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03591224
|Contact: John Papaerstergiou, B.Sc.Phm||416-461-7533 ext firstname.lastname@example.org|
|Contact: Wilson Li, B.Sc.Phm||416-461-7533 ext email@example.com|
|John Papastergiou Pharmacy Ltd - Store#500||Recruiting|
|Toronto, Ontario, Canada, M4C 1H6|
|Contact: John Papastergiou, B.Sc.Phm 416-461-2453 ext 33 firstname.lastname@example.org|
|Contact: Wilson Li, B.Sc.Phm 416-461-7533 ext 33 email@example.com|
|John Papastergiou Pharmacy Ltd - Store#994||Recruiting|
|Toronto, Ontario, Canada, M4J 1L2|
|Contact: John Papastergiou, BSc.Phm 416-461-7533 ext 33 firstname.lastname@example.org|
|Contact: Wilson Li, B.Sc.Phm 416-461-7533 ext 33 email@example.com|
|Principal Investigator:||John Papastergiou, B.Sc.Phm||University of Toronto|
|Study Director:||Wilson Li, B.Sc.Phm||John Papastergiou Pharmacy Ltd|