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Pharmacogenetic TestingOffiGeneNCT06210321

Pharmacogenetic Testing at Community Pharmacy

A study testing Prescription of escitalopram using pharmacogenetic testing in people with Pharmacogenetic Testing, run by Chantal Csajka.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pharmacogenetic Testing
What is being tested?
Prescription of escitalopram using pharmacogenetic testing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
No sites listed yet
Study dates
15 Aug 2025to 14 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Chantal Csajka, Pre contact

+4121 314 42 63

chantal.csajka@chuv.ch

About this study

Official title: 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.

Read the 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.

Being tested
Prescription of escitalopram using pharmacogenetic testing
Keywords
Community pharmacy, Escitalopram

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prescription of escitalopram using pharmacogenetic testingOther

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

Study groups in NCT06210321
Study groupRoleWhat they receive
Intervention armOtherAdjustment of antidepressant treatment according to pharmacogenetic results obtained by genetic testing for cytochrome CYP 2C19 (alleles *2, *3 and *17)
Receives: Other: Prescription of escitalopram using pharmacogenetic testing
Control armNo interventionDelivery of escitalopram treatment as prescribed. Genetic analysis will be performed in batch at the end of the follow-up period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment to last follow-up: circa 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2024
  2. Study start15 Aug 2025 (estimated)
  3. Primary completion14 Aug 2027 (estimated)
  4. Study completion14 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06210321
Sponsor's protocol ID
OffiGene01
Acronym
OffiGene
Status last verified
Jun 2025
First submitted
23 Mar 2023
Last updated
5 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 28378927

  • 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.

    PubMed 16409140

  • 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.

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

  • 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/.

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

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

  • 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.

    PubMed 12571262

  • 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.

    PubMed 11710893

  • 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.

    PubMed 32506666

  • 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.

    PubMed 26752539

Questions about this trial

What is this clinical trial studying?

A study testing Prescription of escitalopram using pharmacogenetic testing in people with Pharmacogenetic Testing, run by Chantal Csajka.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chantal Csajka, Pre (+4121 314 42 63, chantal.csajka@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants in the intervention and control groups who experienced a treatment failure on escitalopram. (time frame: From enrollment to last follow-up: circa 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06210321, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.

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