Pharmacogenetic Testing at Community Pharmacy

NCT06210321 | Not Yet Recruiting

• 1 other identifier: OffiGene01
• Study Type: interventional
• Target: 270
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pharmacogenetic Testing

Keywords

Community pharmacy; Escitalopram

Outcome Measures

Primary Outcomes (1)

• Number of participants in the intervention and control groups who experienced a treatment failure on escitalopram.

  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.

  From enrollment to last follow-up: circa 3 months

Study Arms (2)

Intervention arm

OTHER

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

Control arm

NO INTERVENTION

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

Interventions

Prescription of escitalopram using pharmacogenetic testing OTHER

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

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chantal Csajka: lead

Related Publications (11)

• 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.

  PMID: 28378927 BACKGROUND

• 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.

  PMID: 16409140 BACKGROUND

• 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.

  BACKGROUND

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

  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/.

  BACKGROUND

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

  BACKGROUND

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

  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.

  PMID: 12571262 BACKGROUND

• 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.

  PMID: 11710893 BACKGROUND

• 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.

  PMID: 32506666 BACKGROUND

• 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.

  PMID: 26752539 BACKGROUND

Central Study Contacts

Chantal Csajka, Pre

CONTACT

+4121 314 42 63; chantal.csajka@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients in each group will be blinded, as CYP2C19 genetic information is not given until the study is completed.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: This study consists of two groups, an intervention group using CYP2C19 genetic information to validate escitalopram prescriptions, and a control group without using CYP2C19 genetic information.

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: January 18, 2024
• Study Start: August 15, 2025
• Primary Completion (Estimated): August 14, 2027
• Study Completion (Estimated): August 14, 2027
• Last Updated: June 5, 2025

Record last verified: 2025-06