Pharmacogenetic examination guided by a pharmacist in the treatment with antidepressants
Zusammenfassung der Studie
In this study of the psychiatric clinic Solothurn, the effectiveness and tolerability of medication therapy for depression are examined in three groups of hospitalized patients. In the intervention group, the physician selects and doses the medication for depression based on a pharmacist-guided pharmacogenetic examination. In the standard group, the medication for depression is selected and dosed by the physician without the support of genetic examinations, according to the current standard procedure. If, after the first week, the treating physician deems no adjustment to a new antidepressant necessary, the course of these patients is followed until their discharge in an observation group (observational arm). The medications used are all approved in Switzerland for the treatment of depression. All study participants will be hospitalized for at least five weeks and observed until their discharge from the clinic. The allocation to the intervention group (Group A) or the standard group (Group B) is done randomly (in a 1:1 ratio) after the first week of hospitalization, provided the treating physician considers a change or new adjustment to an antidepressant necessary. Overall, we aim to include and examine 95 patients in both study groups A and B.
(BASEC)
Untersuchte Intervention
Pharmacist-initiated examination of genetic variants (pharmacogenetic examination) in the patient, prior to the prescription of a medication for depression.
(BASEC)
Untersuchte Krankheit(en)
Unipolar depression
(BASEC)
≥ 18 years old Diagnosis of unipolar moderate or severe depressive episode or recurrent depressive disorder (ICD10: F32.1/32.2/33.1/33.2) HAM-D17 ≥ 17 (BASEC)
Ausschlusskriterien
Acute suicide risk Psychotic symptoms Other severe psychiatric disorders except for depression (BASEC)
Studienstandort
Luzern, Zürich, Andere
(BASEC)
Solothurn, Münchenbuchsee, St. Urban, Sarnen
(BASEC)
Sponsor
Psychiatrie Solothurner Spitäler
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
PD Dr. med. Thorsten Mikoteit
+41326271111
thorsten.mikoteit@clutterspital.so.chPsychiatrie Solothurner Spitäler
(BASEC)
Allgemeine Auskünfte
Psychiatrische Dienste Solothurn,
+41 61 207 61 78
thorsten.mikoteit@clutterspital.so.ch(ICTRP)
Wissenschaftliche Auskünfte
Psychiatrische Dienste Solothurn,
+41 61 207 61 78
thorsten.mikoteit@clutterspital.so.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
14.08.2020
(BASEC)
ICTRP Studien-ID
NCT04507555 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Pharmacist guided pre-emptive pharmacogenetic testing in antidepressant therapy (BASEC)
Wissenschaftlicher Titel
Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy (ICTRP)
Öffentlicher Titel
Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy (ICTRP)
Untersuchte Krankheit(en)
Depression (ICTRP)
Untersuchte Intervention
Procedure: Pharmacist-guided pharmacogenetic (PGx) testing for antidepressant selection and dosing;Procedure: Standard care antidepressant selection and dosing (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
Gender: All
Maximum age: N/A
Minimum age: 18 Years
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 (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
rate of response to the antidepressant therapy at the end of week 4 (ICTRP)
Time to response;Remission rate;Overall change in 17 item Hamilton rating scale for Depression (HAM-D17) from baseline to week 4;Time till discharge;Patient depression self-rating;Side effect measure (self-rated frequency, intensity and burden of side effects, FIBSER score);Number of adverse events related to antidepressant pharmacotherapy (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Psychiatrische Dienste Solothurn;Privatklinik Wyss;Luzerner Psychiatrie AG;Psychiatrische Universit?tsklinik Z?rich (ICTRP)
Weitere Kontakte
Thorsten Mikoteit, PD Dr. med.;C?line St?uble, MSc, celine.staeuble@unibas.ch, +41 61 207 61 78, Psychiatrische Dienste Solothurn, (ICTRP)
Sekundäre IDs
PrePGx_ex20Mikoteit (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT04507555 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar