Abstract
BackgroundIt is known that only 50% of patients diagnosed with major depressive disorders (MDD) respond to the first-line antidepressant treatment. Accordingly, there is a need to improve response rates to reduce healthcare costs and patient suffering. One approach to increase rates of treatment response might be the integration of pharmacogenetic (PGx) testing to stratify antidepressant drug selection. The goal of PGx assessments is to identify patients who have an increased risk to experience adverse drug reactions or non-response to specific drugs. Especially for antidepressants, there is compiling evidence on PGx influencing drug exposure as well as response.MethodsThis study is an open-label, randomized controlled trial conducted in two study centers in Switzerland: (1) the Psychiatric Clinic of Solothurn and (2) the Private Clinic Wyss in Münchenbuchsee. Adult inpatients diagnosed with a unipolar moderate or severe depressive episode are recruited at clinic admission and are included in the study. If the adjustment to a new antidepressant pharmacotherapy is necessary, the participants are randomized to either Arm A (intervention group) or Arm B (control group). If no new antidepressant pharmacotherapy is introduced the participants will be followed up in an observational arm. The intervention is the service of pharmacist-guided pre-emptive PGx testing to support clinical decision making on antidepressant selection and dosing. As a comparison, in the control group, the antidepressant pharmacotherapy is selected by the treating physician according to current treatment guidelines (standard of care) without the knowledge of PGx test results and support of clinical pharmacists. The primary outcome of this study compares the response rates under antidepressant treatment after 4 weeks between intervention and control arm.DiscussionThe findings from this clinical trial are expected to have a direct impact on inter-professional collaborations for the handling and use of PGx data in psychiatric practice.Trial registrationClinicalTrials.govNCT04507555. Registered on August 11, 2020. Swiss National Clinical Trials Portal SNCTP000004015. Registered August 18, 2020.
Highlights
Background and rationale {6a} Successful treatment of depression remains challenging, considering the fact, that only 50% of patients suffering from major depressive disorders respond to the first-line antidepressant treatment [1, 2]
This assumption is based on a limited number of studies, where the ABCB1 genotype was linked to antidepressant treatment response [11,12,13]
The newly prescribed antidepressant pharmacotherapy intake is continuously documented and therapy response observed over a period of 28 days with weekly assessments of adverse events related to the antidepressant medication and scorings of HAM-D17 as well as patient self-assessments of FIBSER score and Beck depression-inventory II (BDI-II) score
Summary
Study setting {9} This is a multicenter clinical trial conducted in Switzerland, at the Psychiatric Clinic of the Solothurner Spitäler AG in Solothurn and the Private Clinic Wyss in Münchenbuchsee. In arm A, a clinical pharmacist will process and evaluate the results from PGx testing (Stratipharm®) in context of the individual patient history as well as current co-medication and forward an individualized recommendation for antidepressant selection and dosing to the treating physician at day 0 In both arms, the newly prescribed antidepressant pharmacotherapy intake is continuously documented and therapy response observed over a period of 28 days with weekly assessments of adverse events related to the antidepressant medication (using CTCAE version 5.0) and scorings of HAM-D17 (days 0, 7, 14, 21, and 28; ±3 days) as well as patient self-assessments of FIBSER score (days 0, 7, 14, 21, and 28; ±3 days) and BDI-II score (days 0, 14, and 28; ±3 days) (see Table 1). Our findings will be communicated during national and international congresses relevant to clinicians and academics of associated fields
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
