Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy
PD Dr. med. Thorsten Mikoteit
190 participants
Sep 15, 2020
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- ≥ 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 Criteria7
- 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
Interventions
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.
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(4)
View Full Details on ClinicalTrials.gov
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NCT04507555