Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy

NCT ID: NCT04507555

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2025-12-31

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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

Group Type: ACTIVE_COMPARATOR

Standard care antidepressant selection and dosing

Intervention Type: PROCEDURE

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.

Observational

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Psychiatrische Dienste Solothurn

UNKNOWN

Sponsor Role: collaborator

Privatklinik Wyss

UNKNOWN

Sponsor Role: collaborator

Luzerner Psychiatrie AG

UNKNOWN

Sponsor Role: collaborator

Psychiatrische Universitätsklinik Zürich

UNKNOWN

Sponsor Role: collaborator

PD Dr. med. Thorsten Mikoteit

OTHER

Sponsor Role: lead

Responsible Party

PD Dr. med. Thorsten Mikoteit

Deputy Head Physician Division Psychiatry

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Thorsten Mikoteit, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Psychiatrische Dienste Solothurn

Locations

Privatklinik Wyss

Münchenbuchsee, Canton of Bern, Switzerland

Site Status: RECRUITING

Psychiatrische Dienste Solothurn

Solothurn, Canton of Solothurn, Switzerland

Site Status: RECRUITING

Luzerner Psychiatrie AG

Sankt Urban, , Switzerland

Site Status: RECRUITING

Psychiatrische Universitätsklinik Zürich

Zurich, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Céline Stäuble, MSc

Role: CONTACT

celine.staeuble@unibas.ch

+41 61 207 61 78

Florine Marianne Wiss, MSc

Role: CONTACT

florine.wiss@unibas.ch

+41 61 207 66 22

Facility Contacts

Christian Imboden, Dr. med.

Role: primary

info@privatklinik-wyss.ch

+4131 868 33 33

Thorsten Mikoteit, PD Dr. med.

Role: primary

thorsten.mikoteit@spital.so.ch

+41 32 627 11 11

Jochen Mutschler, Prof. Dr.

Role: primary

jochen.mutschler@lups.ch

+41 58 856 55 55

Sebastian Olbrich, Dr.

Role: primary

sebastian.olbrich@pukzh.ch

+41 58 384 21 11

References

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.

Reference Type: DERIVED

PMID: 34906208 (View on PubMed)

Other Identifiers

PrePGx_ex20Mikoteit

Identifier Type: -

Identifier Source: org_study_id