Pharmacogenetic examination guided by a pharmacist in the treatment with antidepressants
Descrizione riassuntiva dello studio
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)
Intervento studiato
Pharmacist-initiated examination of genetic variants (pharmacogenetic examination) in the patient, prior to the prescription of a medication for depression.
(BASEC)
Malattie studiate
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)
Criteri di esclusione
Acute suicide risk Psychotic symptoms Other severe psychiatric disorders except for depression (BASEC)
Luogo dello studio
Luzern, Zurigo, Altro
(BASEC)
Solothurn, Münchenbuchsee, St. Urban, Sarnen
(BASEC)
Sponsor
Psychiatrie Solothurner Spitäler
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
PD Dr. med. Thorsten Mikoteit
+41326271111
thorsten.mikoteit@clutterspital.so.chPsychiatrie Solothurner Spitäler
(BASEC)
Informazioni generali
Psychiatrische Dienste Solothurn,
+41 61 207 61 78
thorsten.mikoteit@clutterspital.so.ch(ICTRP)
Informazioni scientifiche
Psychiatrische Dienste Solothurn,
+41 61 207 61 78
thorsten.mikoteit@clutterspital.so.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
14.08.2020
(BASEC)
ID di studio ICTRP
NCT04507555 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Pharmacist guided pre-emptive pharmacogenetic testing in antidepressant therapy (BASEC)
Titolo accademico
Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy (ICTRP)
Titolo pubblico
Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy (ICTRP)
Malattie studiate
Depression (ICTRP)
Intervento studiato
Procedure: Pharmacist-guided pharmacogenetic (PGx) testing for antidepressant selection and dosing;Procedure: Standard care antidepressant selection and dosing (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
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)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
Psychiatrische Dienste Solothurn;Privatklinik Wyss;Luzerner Psychiatrie AG;Psychiatrische Universit?tsklinik Z?rich (ICTRP)
Contatti aggiuntivi
Thorsten Mikoteit, PD Dr. med.;C?line St?uble, MSc, celine.staeuble@unibas.ch, +41 61 207 61 78, Psychiatrische Dienste Solothurn, (ICTRP)
ID secondari
PrePGx_ex20Mikoteit (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT04507555 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile