Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy

Depression Clinical Trial

— PrePGx  

Official title:

Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04507555
• Other study ID #: PrePGx_ex20Mikoteit
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: University of Basel
• Contact: Céline Stäuble, MSc
• Phone: +41 61 207 61 78
• Email: celine.staeuble[@]unibas.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression

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.
• 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.

Locations

Country	Name	City	State
Switzerland	Privatklinik Wyss	Münchenbuchsee	Bern
Switzerland	Psychiatrische Dienste Solothurn	Solothurn

Sponsors (3)

Lead Sponsor	Collaborator
PD Dr. med. Thorsten Mikoteit	Privatklinik Wyss, Psychiatrische Dienste Solothurn

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Remission rate	17 item Hamilton rating scale for Depression (HAM-D17) score = 8	28 days
Secondary	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
Secondary	Time till discharge	time span from admission (randomization) to discharge from inpatient treatment	assessed up to 3 month
Secondary	Patient depression self-rating	two weekly assessment with Beck's Depression Inventory questionnaire (BDI-II)	28 days
Secondary	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
Secondary	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