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Recruiting NCT04507555

Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy

No phase Interventional Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pharmacist-guided pharmacogenetic (PGx) testing for antidepressant selection and dosing, Standard care antidepressant selection and dosing.
Who it may be relevant to
Registry conditions: Depression. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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 his
  • 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.

Primary outcome measures

  • rate of response to the antidepressant therapy at the end of week 4 [Time frame: 28 days]
Secondary outcome measures (7)
  • Time to response [Time frame: 28 days]
  • Remission rate [Time frame: 28 days]
  • Overall change in 17 item Hamilton rating scale for Depression (HAM-D17) from baseline to week 4 [Time frame: 28 days]
  • Time till discharge [Time frame: assessed up to 3 month]
  • Patient depression self-rating [Time frame: 28 days]
  • Side effect measure (self-rated frequency, intensity and burden of side effects, FIBSER score) [Time frame: 28 days]
  • Number of adverse events related to antidepressant pharmacotherapy [Time frame: 28 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 4 centers
  • Privatklinik Wyss — Münchenbuchsee
  • Psychiatrische Dienste Solothurn — Solothurn
  • Luzerner Psychiatrie AG — Sankt Urban
  • Psychiatrische Universitätsklinik Zürich — Zurich

Publications

  • 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

Identifiers

NCT: NCT04507555 · PrePGx_ex20Mikoteit

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗