Pharmacogenetic Testing at Community Pharmacy

NCT ID: NCT06210321

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2027-08-14

Brief Summary

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.

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.

Conditions

Pharmacogenetic Testing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Intervention arm

Adjustment of antidepressant treatment according to pharmacogenetic results obtained by genetic testing for cytochrome CYP 2C19 (alleles \*2, \*3 and \*17)

Group Type: OTHER

Prescription of escitalopram using pharmacogenetic testing

Intervention Type: OTHER

Adjustment of escitalopram treatment according to pharmacogenetic results obtained by genetic testing for cytochrome CYP 2C19 (alleles \*2, \*3 and \*17)

Control arm

Delivery of escitalopram treatment as prescribed. Genetic analysis will be performed in batch at the end of the follow-up period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chantal Csajka

OTHER

Sponsor Role: lead

Responsible Party

Chantal Csajka

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Chantal Csajka, Pre

Role: CONTACT

chantal.csajka@chuv.ch

+4121 314 42 63

References

Zhou Y, Ingelman-Sundberg M, Lauschke VM. Worldwide Distribution of Cytochrome P450 Alleles: A Meta-analysis of Population-scale Sequencing Projects. Clin Pharmacol Ther. 2017 Oct;102(4):688-700. doi: 10.1002/cpt.690. Epub 2017 May 26.

Reference Type: BACKGROUND

PMID: 28378927 (View on PubMed)

Eichelbaum M, Ingelman-Sundberg M, Evans WE. Pharmacogenomics and individualized drug therapy. Annu Rev Med. 2006;57:119-37. doi: 10.1146/annurev.med.56.082103.104724.

Reference Type: BACKGROUND

PMID: 16409140 (View on PubMed)

U.S. Food and Drug Administration. Table of pharmacogenomic biomarkers in drug labeling. https://www.fda.gov/drugs/science-and-research-drugs/table-pharmacogenomic-biomarkers-drug-labeling/. Accessed November, 15 2022.

Reference Type: BACKGROUND

CHUV - Département oncologie. Une médecine sur mesure grâce à l'analyse génétique des tumeurs. 30.07.2018

Reference Type: BACKGROUND

Veronika Litinski RD, PH. D., Boyko Kabakchiev, PH. D., Lou Carsley, Liz Garman, Gil McGowan, Gouri Mukerjee, PH. D. Pillcheck 2021 [Available from: https://www.pillcheck.ca/.

Reference Type: BACKGROUND

Prof. Dr Theo Dingermann, Prof. Dr. Dieter Steinhilber. Stratipharm [cited 2022 03.06]. Available from: https://www.stratipharm.de/.

Reference Type: BACKGROUND

Loi sur l'analyse génétique : renforcement de la protection contre les abus, (2022).

Reference Type: BACKGROUND

Evans WE, McLeod HL. Pharmacogenomics--drug disposition, drug targets, and side effects. N Engl J Med. 2003 Feb 6;348(6):538-49. doi: 10.1056/NEJMra020526. No abstract available.

Reference Type: BACKGROUND

PMID: 12571262 (View on PubMed)

Phillips KA, Veenstra DL, Oren E, Lee JK, Sadee W. Potential role of pharmacogenomics in reducing adverse drug reactions: a systematic review. JAMA. 2001 Nov 14;286(18):2270-9. doi: 10.1001/jama.286.18.2270.

Reference Type: BACKGROUND

PMID: 11710893 (View on PubMed)

Ionova Y, Ashenhurst J, Zhan J, Nhan H, Kosinski C, Tamraz B, Chubb A. CYP2C19 Allele Frequencies in Over 2.2 Million Direct-to-Consumer Genetics Research Participants and the Potential Implication for Prescriptions in a Large Health System. Clin Transl Sci. 2020 Nov;13(6):1298-1306. doi: 10.1111/cts.12830. Epub 2020 Jul 21.

Reference Type: BACKGROUND

PMID: 32506666 (View on PubMed)

Berm EJ, Looff Md, Wilffert B, Boersma C, Annemans L, Vegter S, Boven JF, Postma MJ. Economic Evaluations of Pharmacogenetic and Pharmacogenomic Screening Tests: A Systematic Review. Second Update of the Literature. PLoS One. 2016 Jan 11;11(1):e0146262. doi: 10.1371/journal.pone.0146262. eCollection 2016.

Reference Type: BACKGROUND

PMID: 26752539 (View on PubMed)

Other Identifiers

OffiGene01

Identifier Type: -

Identifier Source: org_study_id