Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04507555

Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy

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

In this study at the Solothurn Psychiatric Clinic, the investigators compare the effectiveness and tolerability of antidepressant pharmacotherapy in three groups. In the intervention group, the physician selects and doses the medication for depression based on a pharmacogenetic examination conducted by a clinical pharmacist. In the standard group, the treating physician selects and doses the antidepressant drug without the support of genetic testing, in accordance with current standard practice. If after the first week of hopsitalization no adjustment to a new antidepressant is necessary, the investigators will monitor the progress of these patients until they leave the clinic in an observational arm. The drugs used are all approved in Switzerland for the treatment of depression. Classification into the intervention or standard group is made randomly after the first week of hospitalisation, if the treating physician deems it necessary to change or readjust the antidepressant pharmacotherapy. The probability of allocation to one of the two study groups is 50%. All study participants will be hospitalized for at least five weeks and monitored until they leave the clinic. In total, it is planned to include and examine 95 patients each into the intervention and standard group.

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

CONTACT

F

Florine Marianne Wiss, MSc

CONTACT

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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