Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy

Summary

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

• Depression

Interventions

PROCEDURE

Pharmacist-guided pharmacogenetic (PGx) testing for antidepressant selection and dosing

The study intervention is the service of pharmacist guided pre-emptive PGx testing to support clinical decision making for antidepressant selection and dosing. This service involves genotyping and thereof evidence-based genotype interpretation commercially offered as Stratipharm® (humatrix AG, Pfungstadt Germany, https://www.stratipharm.de). Furthermore, clinical pharmacists will process and evaluate the results from PGx testing (Stratipharm®) in context of the individual patient medication history as well as current co-medication and forward an individualized recommendation for antidepressant selection and dosing to the treating psychiatrist.

PROCEDURE

Standard care antidepressant selection and dosing

Selection and dosing of the new antidepressant pharmacotherapy will be determined by the treating investigator alone, according to current standard of care considering clinical factors only.

Sponsors & Collaborators

• Psychiatrische Dienste Solothurn

  collaborator UNKNOWN

• Privatklinik Wyss

  collaborator UNKNOWN

• Luzerner Psychiatrie AG

  collaborator UNKNOWN

• Psychiatrische Universitätsklinik Zürich

  collaborator UNKNOWN

• PD Dr. med. Thorsten Mikoteit

  lead OTHER

Principal Investigators

• Thorsten Mikoteit, PD Dr. med. · Psychiatrische Dienste Solothurn

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-15

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• Switzerland

Study Locations