Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy

Not Applicable

Recruiting

• Conditions: Depression
• Interventions: Procedure: Pharmacist-guided pharmacogenetic (PGx) testing for antidepressant selection and dosing; Procedure: Standard care antidepressant selection and dosing

• Registration Number: NCT04507555
• Lead Sponsor: PD Dr. med. Thorsten Mikoteit

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-07
• Study First Posted: 2020-08-11
• Study Start: 2020-09-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Pharmacist-guided pharmacogenetic (PGx) testing for antidepressant selection and dosing	-
Standard Care	Standard care antidepressant selection and dosing	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Psychiatrische Dienste Solothurn; 🇨🇭 Solothurn, Switzerland

Psychiatrische Universitätsklinik Zürich; 🇨🇭 Zürich, Switzerland

Privatklinik Wyss; 🇨🇭 Münchenbuchsee, Bern, Switzerland

Luzerner Psychiatrie AG; 🇨🇭 St. Urban, Switzerland