Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy (PrePGx)

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.

Study Overview

• Status: Recruiting
• Conditions: Depression
• Intervention / Treatment: Procedure: Pharmacist-guided pharmacogenetic (PGx) testing for antidepressant selection and dosing; Procedure: Standard care antidepressant selection and dosing

• Study Type: Interventional
• Enrollment (Anticipated): 190
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Céline Stäuble, MSc; Phone Number: +41 61 207 61 78; Email: celine.staeuble@unibas.ch

Study Locations

• Switzerland
  • Solothurn, Switzerland, 4503
    • Recruiting
    • Psychiatrische Dienste Solothurn
    • Contact: Thorsten Mikoteit, PD Dr. med.; Phone Number: +41 32 627 11 11; Email: thorsten.mikoteit@spital.so.ch
  • Bern
    • Münchenbuchsee, Bern, Switzerland, 3053
      • Recruiting
      • Privatklinik Wyss
      • Contact: Christian Imboden, Dr. med.; Phone Number: +4131 868 33 33; Email: info@privatklinik-wyss.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥ 18 years old
• Diagnosis unipolar moderate or severe depressive episode or recurrent depressive disorder (ICD10: F32.1/32.2/33.1/33.2)
• HAM-D17 ≥ 17

Exclusion Criteria:

• Acute suicide risk
• Psychotic symptomatology
• Other acute serious psychiatric disorder other than depression
• Excessive consumption of alcohol and/or drugs
• Severe acute - or severe chronic somatic diseases
• Pregnant / lactating women
• Under current treatment with fluoxetine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	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.
Active Comparator: Standard Care	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.
No Intervention: Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of response to the antidepressant therapy at the end of week 4	response is determined as a reduction in the Hamilton Depression (HAM-D17) Scale score of at least 50 % of the baseline value	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to response	time span from start of antidepressant pharmacotherapy until first assessed response (= HAM-D17 reduction of at least 50 % compared to baseline	28 days
Remission rate	17 item Hamilton rating scale for Depression (HAM-D17) score ≤ 8	28 days
Overall change in 17 item Hamilton rating scale for Depression (HAM-D17) from baseline to week 4	minimum value: 0, maximum value: 52 ; higher scores mean worse outcome	28 days
Time till discharge	time span from admission (randomization) to discharge from inpatient treatment	assessed up to 3 month
Patient depression self-rating	two weekly assessment with Beck's Depression Inventory questionnaire (BDI-II)	28 days
Side effect measure (self-rated frequency, intensity and burden of side effects, FIBSER score)	weekly assessment, minimum value: 0, maximum value: 18 ; higher scores mean worse outcome	28 days
Number of adverse events related to antidepressant pharmacotherapy	severity grading ≥ 2 (using CTCAE version 5.0) and causality to antidepressant pharmacotherapy assessed as possible, probable or definite	28 days

Collaborators and Investigators

• Sponsor: PD Dr. med. Thorsten Mikoteit
• Collaborators: Psychiatrische Dienste Solothurn; Privatklinik Wyss
• Investigators: Principal Investigator: Thorsten Mikoteit, PD Dr. med., Psychiatrische Dienste Solothurn

Publications and helpful links

General Publications

• Stauble CK, Lampert ML, Allemann S, Hatzinger M, Hersberger KE, Meyer Zu Schwabedissen HE, Imboden C, Mikoteit T. Pharmacist-guided pre-emptive pharmacogenetic testing in antidepressant therapy (PrePGx): study protocol for an open-label, randomized controlled trial. Trials. 2021 Dec 14;22(1):919. doi: 10.1186/s13063-021-05724-5.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Anticipated): August 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 7, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Psychotropic Drugs; Antidepressive Agents
• Other Study ID Numbers: PrePGx_ex20Mikoteit

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No