Pharmacogenomic Testing to Optimize Antidepressant Drug Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

213 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-17

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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

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Depression Anxiety Major Depressive Disorder Generalized Anxiety Disorder Mood Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

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.

Study Groups

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Intervention

Pharmacist optimizing antidepressant therapy using the patient's personalized pharmacogenomic report to make recommendations.

Group Type ACTIVE_COMPARATOR

Pharmacogenomic Testing

Intervention Type OTHER

pharmacogenomic drug response test provides personalized insights on a patient's predicted response to medications based on metabolism

Control

Pharmacist optimizing antidepressant therapy based on standard of care

Group Type PLACEBO_COMPARATOR

Pharmacist Standard of Care

Intervention Type OTHER

Pharmacist providing standard of care as per usual practice

Interventions

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Pharmacogenomic Testing

pharmacogenomic drug response test provides personalized insights on a patient's predicted response to medications based on metabolism

Intervention Type OTHER

Pharmacist Standard of Care

Pharmacist providing standard of care as per usual practice

Intervention Type OTHER

Other Intervention Names

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Pillcheck Geneyouin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes