Pharmacogenetic examination guided by a pharmacist in the treatment with antidepressants
Résumé de l'étude
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)
Intervention étudiée
Pharmacist-initiated examination of genetic variants (pharmacogenetic examination) in the patient, prior to the prescription of a medication for depression.
(BASEC)
Maladie en cours d'investigation
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)
Critères d'exclusion
Acute suicide risk Psychotic symptoms Other severe psychiatric disorders except for depression (BASEC)
Lieu de l’étude
Luzern, Zurich, Autre
(BASEC)
Solothurn, Münchenbuchsee, St. Urban, Sarnen
(BASEC)
Sponsor
Psychiatrie Solothurner Spitäler
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
PD Dr. med. Thorsten Mikoteit
+41326271111
thorsten.mikoteit@clutterspital.so.chPsychiatrie Solothurner Spitäler
(BASEC)
Informations générales
Psychiatrische Dienste Solothurn,
+41 61 207 61 78
thorsten.mikoteit@clutterspital.so.ch(ICTRP)
Informations scientifiques
Psychiatrische Dienste Solothurn,
+41 61 207 61 78
thorsten.mikoteit@clutterspital.so.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
14.08.2020
(BASEC)
Identifiant de l'essai ICTRP
NCT04507555 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Pharmacist guided pre-emptive pharmacogenetic testing in antidepressant therapy (BASEC)
Titre académique
Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy (ICTRP)
Titre public
Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy (ICTRP)
Maladie en cours d'investigation
Depression (ICTRP)
Intervention étudiée
Procedure: Pharmacist-guided pharmacogenetic (PGx) testing for antidepressant selection and dosing;Procedure: Standard care antidepressant selection and dosing (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
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)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
Psychiatrische Dienste Solothurn;Privatklinik Wyss;Luzerner Psychiatrie AG;Psychiatrische Universit?tsklinik Z?rich (ICTRP)
Contacts supplémentaires
Thorsten Mikoteit, PD Dr. med.;C?line St?uble, MSc, celine.staeuble@unibas.ch, +41 61 207 61 78, Psychiatrische Dienste Solothurn, (ICTRP)
ID secondaires
PrePGx_ex20Mikoteit (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT04507555 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible