Pharmacogenetic Testing at Community Pharmacy (OffiGene)

January 15, 2024 updated by: Chantal Csajka, Centre Hospitalier Universitaire Vaudois

Randomised Controlled Study of the Efficacy and Acceptability of a Pharmacogenetic Test in the Management of Patients Treated With Escitalopram.

The purpose of this study is to assess the clinical impact of reducing treatment failure rates after using genetic information targeting CYP2C19 in validating escitalopram prescription. 5 pharmacies in the canton of Vaud (Lausanne, Switzerland) will participate in the study.

The study will also explored the ability to perform the test in community pharmacy, physician and pharmacist approval of prescription changes, patient acceptance of the test and dose changes, the economic impact of the test, the association between genetic polymorphisms and therapeutic failures and the degree of satisfaction, barriers and facilitators by stakeholders.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Response to medication depends on many clinical, demographic, environmental, and genetic factors. Non-genetic factors that are often considered when prescribing treatments address not only drug-drug interactions, but also the patient's environment, comorbidities, gender, and age. Genetic factors, which are not commonly considered during prescribing except for some drugs, account for 15-30% of the variability in drug response. From a pharmacokinetic point of view, genetic polymorphisms are likely to modify drug absorption, metabolism, transport and elimination. Data from the literature indicate that the concentration profiles of many drugs are genetically influenced. It is also well known that genetic polymorphisms that alter the targeting of some drugs can alter drug response, especially in oncology.

Personalization of medicine is a fundamental approach to treating patients individually. Pilot studies to integrate pharmacogenetics into practice are already being conducted in hospitals, and some pharmacies abroad offer pharmacogenetic testing, as in Canada and Germany.

In Switzerland, a new Ordinance on Genetic Analysis Act was passed on September 23, 2022, allowing pharmacists to carry out genetic testing in the medical field.Because of the increasing evidence of the influence of CYP2C19 genetic polymorphisms on the efficacy and toxicity of escitalopram, the high prevalence of prescription of this drug in the treatment of depression, the prevalence of genetic polymorphisms in the Caucasian population (30% ultra-rapid metabolizers and 4% poor metabolizers) and the potential costs to public health, this drug was chosen as a prototype for this pilot project.

Therefore, investigators want to conduct a pilot study to evaluate the efficacy, safety, feasibility, and cost-effectiveness of pharmacy-based genetic testing as part of patient care management and identified barriers to using such tests.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Must consent to participate in the study,
  • Must sign consent,
  • Must be able to follow and understand the study procedures,
  • Initiation of escitalopram treatment for unipolar depression with or without anxiety

Exclusion Criteria:

  • Other condition than depression (such as panic disorder)
  • Escitalopram treatment already received
  • Not able to consent to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intervention arm
Adjustment of antidepressant treatment according to pharmacogenetic results obtained by genetic testing for cytochrome CYP 2C19 (alleles *2, *3 and *17)
Other: Prescription of escitalopram using pharmacogenetic testing
Adjustment of escitalopram treatment according to pharmacogenetic results obtained by genetic testing for cytochrome CYP 2C19 (alleles *2, *3 and *17)
No Intervention: Control arm
Delivery of escitalopram treatment as prescribed. Genetic analysis will be performed in batch at the end of the follow-up period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants in the intervention and control groups who experienced a treatment failure on escitalopram.
Time Frame: 20 months
Number of escitalopram treatment failures in patients with escitalopram prescription based on CYP2C19 genetic testing information versus the control group prior to normal care. Treatment failure is defined here as discontinuation, dose change, or treatment change.
20 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 5, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

March 23, 2023

First Submitted That Met QC Criteria

January 15, 2024

First Posted (Estimated)

January 18, 2024

Study Record Updates

Last Update Posted (Estimated)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OffiGene01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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