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/34906208Actively Recruiting
Led by PD Dr. med. Thorsten Mikoteit · Updated on 2025-01-20
190
Participants Needed
4
Research Sites
276 weeks
Total Duration
P
PD Dr. med. Thorsten Mikoteit
Lead Sponsor
P
Psychiatrische Dienste Solothurn
Collaborating Sponsor
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
Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy
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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
C
Céline Stäuble, MSc
F
Florine Marianne Wiss, MSc
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Céline K Stäuble, Markus L Lampert, Samuel Allemann...
https://pubmed.ncbi.nlm.nih.gov/34906208