Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy

NCT04507555 | Recruiting

• 1 other identifier: PrePGx_ex20Mikoteit
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Time to response

  28 days

• Remission rate

  28 days

• Overall change in 17 item Hamilton rating scale for Depression (HAM-D17) from baseline to week 4

  28 days

• Time till discharge

  assessed up to 3 month

• Patient depression self-rating

  28 days

Study Arms (3)

Intervention

EXPERIMENTAL

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

Standard Care

ACTIVE COMPARATOR

Procedure: Standard care antidepressant selection and dosing

Observational

NO INTERVENTION

Interventions

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

Intervention

Standard care antidepressant selection and dosing 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.

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PD Dr. med. Thorsten Mikoteit: lead
• Psychiatrische Dienste Solothurn: collaborator
• Privatklinik Wyss: collaborator
• Luzerner Psychiatrie AG: collaborator
• Psychiatrische Universitätsklinik Zürich: collaborator

Study Sites (4)

Privatklinik Wyss

Münchenbuchsee, Canton of Bern, 3053, Switzerland

RECRUITING

Psychiatrische Dienste Solothurn

Solothurn, Canton of Solothurn, 4503, Switzerland

RECRUITING

Luzerner Psychiatrie AG

Sankt Urban, 4915, Switzerland

RECRUITING

Psychiatrische Universitätsklinik Zürich

Zurich, 8032, Switzerland

RECRUITING

Related Publications (1)

• 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.

  PMID: 34906208 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Thorsten Mikoteit, PD Dr. med.

  Psychiatrische Dienste Solothurn

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Céline Stäuble, MSc

CONTACT

+41 61 207 61 78; celine.staeuble@unibas.ch

Florine Marianne Wiss, MSc

CONTACT

+41 61 207 66 22; florine.wiss@unibas.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Head Physician Division Psychiatry

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 11, 2020
• Study Start: September 15, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (4)