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NCT Number: NCT04507555

Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Privatklinik Wyss, Münchenbuchsee, Canton of Bern, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. rate of response to the antidepressant therapy at the end of week 4

    Time frame: 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 outcomes

  1. Time to response

    Time frame: 28 days

    time span from start of antidepressant pharmacotherapy until first assessed response (= HAM-D17 reduction of at least 50 % compared to baseline

  2. Remission rate

    Time frame: 28 days

    17 item Hamilton rating scale for Depression (HAM-D17) score ≤ 8

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

    Time frame: 28 days

    minimum value: 0, maximum value: 52 ; higher scores mean worse outcome

  4. Time till discharge

    Time frame: assessed up to 3 month

    time span from admission (randomization) to discharge from inpatient treatment

  5. Patient depression self-rating

    Time frame: 28 days

    two weekly assessment with Beck's Depression Inventory questionnaire (BDI-II)

  6. Side effect measure (self-rated frequency, intensity and burden of side effects, FIBSER score)

    Time frame: 28 days

    weekly assessment, minimum value: 0, maximum value: 18 ; higher scores mean worse outcome

  7. Number of adverse events related to antidepressant pharmacotherapy

    Time frame: 28 days

    severity grading ≥ 2 (using CTCAE version 5.0) and causality to antidepressant pharmacotherapy assessed as possible, probable or definite

Study contacts

Contact information is provided by the study sponsor or research team.

Céline Stäuble, MSc

CONTACT

[email protected]

+41 61 207 61 78

Florine Marianne Wiss, MSc

CONTACT

[email protected]

+41 61 207 66 22

Sponsors and collaborators

Lead sponsor

PD Dr. med. Thorsten Mikoteit

Other

Collaborators

  • Luzerner Psychiatrie AG
  • Privatklinik Wyss
  • Psychiatrische Dienste Solothurn
  • Psychiatrische Universitätsklinik Zürich

Registry information

Acronym: PrePGx

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Aug 11, 2020
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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