Clinical trial NCT04507555: Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy
Official title: Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: University of Basel
Sponsor class: OTHER
Collaborators: name: Psychiatrische Dienste Solothurn
name: Privatklinik Wyss
name: Luzerner Psychiatrie AG
name: Psychiatrische Universitätsklinik Zürich
First posted: 2020-08-11
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: rate of response to the antidepressant therapy at the end of week 4
timeFrame: 28 days
Secondary outcomes:
measure: Time to response
timeFrame: 28 days
measure: Remission rate
timeFrame: 28 days
measure: Overall change in 17 item Hamilton rating scale for Depression (HAM-D17) from baseline to week 4
timeFrame: 28 days
measure: Time till discharge
timeFrame: assessed up to 3 month
measure: Patient depression self-rating
timeFrame: 28 days
measure: Side effect measure (self-rated frequency, intensity and burden of side effects, FIBSER score)
timeFrame: 28 days
measure: Number of adverse events related to antidepressant pharmacotherapy
timeFrame: 28 days
Other outcomes:
Locations:
city: Münchenbuchsee
country: Switzerland
facility: Privatklinik Wyss
state: Bern
city: Solothurn
country: Switzerland
facility: Psychiatrische Dienste Solothurn
city: St. Urban
country: Switzerland
facility: Luzerner Psychiatrie AG
city: Zürich
country: Switzerland
facility: Psychiatrische Universitätsklinik Zürich
Study officials:
affiliation: Psychiatrische Dienste Solothurn
name: Thorsten Mikoteit, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stauble CK, Lampert ML, Allemann S, Hatzinger M, Hersberger KE, Meyer Zu Schwabedissen HE, Imboden C, Mikoteit T. Pharmacist-guided pre-emptive pharmacogenetic testing in antidepressant therapy (PrePGx): study protocol for an open-label, randomized controlled trial. Trials. 2021 Dec 14;22(1):919. doi: 10.1186/s13063-021-05724-5.