Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04507555

Pharmacist Guided Pre-emptive Pharmacogenetic Testing for Antidepressant Therapy in Depression A Randomized Study Comparing Genetic Testing and Standard Care

Led by PD Dr. med. Thorsten Mikoteit · Updated on 2025-01-20

190

Participants Needed

4

Research Sites

276 weeks

Total Duration

On this page

Sponsors

P

PD Dr. med. Thorsten Mikoteit

Lead Sponsor

P

Psychiatrische Dienste Solothurn

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating how effective and tolerable antidepressant treatments are when guided by pharmacist-led genetic testing compared to standard care in adults with depression. The study focuses on patients diagnosed with moderate or severe unipolar depressive episodes or recurrent depressive disorder. The purpose is to see if using genetic information to select and dose antidepressants improves treatment response during hospitalization. Participants are randomly assigned to one of two groups after the first week of hospitalization if the treating physician decides a medication change is needed. In the intervention group, clinical pharmacists perform genetic testing using the Stratipharm® service and provide personalized medication recommendations to the psychiatrist. The standard group receives antidepressant treatment selected and dosed by the physician without genetic testing. All drugs used are approved in Switzerland for depression treatment. If no change in medication is needed after the first week, patients enter an observational arm and continue monitoring. Patients remain hospitalized for at least five weeks and are monitored until discharge. Researchers assess treatment response at 4 weeks by measuring improvement in depression symptoms. Throughout the study, patients' medication history, co-medications, and progress are tracked. The study plans to enroll 95 patients each in the intervention and standard groups, evaluating how genetic-guided therapy affects antidepressant response and tolerability.

CONDITIONS

Official Title

Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Diagnosed with unipolar moderate or severe depressive episode or recurrent depressive disorder (ICD10: F32.1/32.2/33.1/33.2)
  • Hamilton Depression Rating Scale (HAM-D17) score of 17 or higher
Not Eligible

You will not qualify if you...

  • Acute suicide risk
  • Psychotic symptomatology
  • Other acute serious psychiatric disorders besides depression
  • Excessive use of alcohol and/or drugs
  • Severe acute or chronic physical illnesses
  • Pregnant or breastfeeding women
  • Currently treated with fluoxetine

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Privatklinik Wyss

Münchenbuchsee, Canton of Bern, Switzerland, 3053

Actively Recruiting

2

Psychiatrische Dienste Solothurn

Solothurn, Canton of Solothurn, Switzerland, 4503

Actively Recruiting

3

Luzerner Psychiatrie AG

Sankt Urban, Switzerland, 4915

Actively Recruiting

4

Psychiatrische Universitätsklinik Zürich

Zurich, Switzerland, 8032

Actively Recruiting

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Research Team

C

Céline Stäuble, MSc

F

Florine Marianne Wiss, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Pharmacist-guided pre-emptive pharmacogenetic testing in antidepressant therapy (PrePGx): study protocol for an open-label, randomized controlled trial.

Céline K Stäuble, Markus L Lampert, Samuel Allemann...

https://pubmed.ncbi.nlm.nih.gov/34906208