Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy

Обзор

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.

Вмешательства

• Процедура Pharmacist-guided pharmacogenetic (PGx) testing for antidepressant selection and dosing
  The study intervention is the service of pharmacist guided pre-emptive PGx testing to support clinical decision making for antidepressant selection and dosing. This service involves genotyping and thereof evidence-based genotype interpretation commercially offered as Stratipharm® (humatrix AG, Pfungstadt Germany, https://www.stratipharm.de). Furthermore, clinical pharmacists will process and evaluate the results from PGx testing (Stratipharm®) in context of the individual patient medication his
• Процедура Standard care antidepressant selection and dosing
  Selection and dosing of the new antidepressant pharmacotherapy will be determined by the treating investigator alone, according to current standard of care considering clinical factors only.

Первичные конечные точки

• rate of response to the antidepressant therapy at the end of week 4 [Срок оценки: 28 days]

Вторичные конечные точки (7)

• Time to response [Срок оценки: 28 days]
• Remission rate [Срок оценки: 28 days]
• Overall change in 17 item Hamilton rating scale for Depression (HAM-D17) from baseline to week 4 [Срок оценки: 28 days]
• Time till discharge [Срок оценки: assessed up to 3 month]
• Patient depression self-rating [Срок оценки: 28 days]
• Side effect measure (self-rated frequency, intensity and burden of side effects, FIBSER score) [Срок оценки: 28 days]
• Number of adverse events related to antidepressant pharmacotherapy [Срок оценки: 28 days]

Критерии участия

Критерии включения

• ≥ 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 4 центра

• Privatklinik Wyss — Münchenbuchsee
• Psychiatrische Dienste Solothurn — Solothurn
• Luzerner Psychiatrie AG — Sankt Urban
• Psychiatrische Universitätsklinik Zürich — Zurich

Публикации

• 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. PMID 34906208

Идентификаторы

NCT: NCT04507555 · PrePGx_ex20Mikoteit

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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