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Набор скоро начнётся NCT07480486

Pharmacogenetic-Guided Antidepressant Treatment in Depression

Без фазы С лечением Depression - Major Depressive Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Pharmacogenetic-Guided Treatment, Usual Care.
Кому может быть актуально
Состояния в реестре: Depression - Major Depressive Disorder. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Morocco
Следующий шаг
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Официальное название

Pharmacogenetic-Guided Antidepressant Treatment for Major Depressive Disorder: A Randomized Controlled Trial in Morocco

Обзор

The purpose of this clinical trial is to evaluate whether using pharmacogenetic testing to guide antidepressant treatment can improve outcomes in adults with major depressive disorder in Morocco. Depression is a common mental health condition, and finding the most effective antidepressant for a patient can take time. Some individuals do not respond well to the first medication prescribed or may experience side effects. Pharmacogenetic testing examines genetic variations that can influence how a person processes certain medications. Information about genes involved in drug metabolism, such as CYP2D6 and CYP2C19, may help clinicians choose antidepressants and adjust doses more appropriately for each patient. The main question this study aims to answer is whether treatment guided by pharmacogenetic test results leads to higher remission rates of depressive symptoms compared with usual clinical care. In this study, participants diagnosed with major depressive disorder will be randomly assigned to one of two groups. In the pharmacogenetic-guided group, clinicians will receive the patient's genetic test results and may use this information to guide antidepressant selection and dosing. In the usual care group, antidepressant treatment will be prescribed according to standard clinical practice without access to pharmacogenetic information. Participants will receive antidepressant treatment and will be followed for 12 weeks. During this period, depressive symptoms will be evaluated using standardized clinical questionnaires, including the Patient Health Questionnaire (PHQ-9). Information on treatment response, medication tolerance, and adverse effects will also be collected. This study aims to provide evidence on the potential role of pharmacogenetic-guided treatment in improving depression management and to support the development of personalized medicine approaches in psychiatric care in Morocco.

Вмешательства

  • Диагностический тест Pharmacogenetic-Guided Treatment
    Pharmacogenetic testing used to support personalized antidepressant treatment selection and dose adjustment according to the validated laboratory platform and applicable pharmacogenetic recommendations.
  • Другое Usual Care
    Participants in the control group will receive standard antidepressant treatment according to routine clinical practice. Treatment decisions, including antidepressant selection and dose adjustments, will be made by the treating clinician without access to pharmacogenetic test results

Первичные конечные точки

  • Depression Severity [Срок оценки: 12 weeks post-randomization]
Вторичные конечные точки (4)
  • Depression Remission [Срок оценки: 12 weeks post-randomization]
  • Depression Response [Срок оценки: 12 weeks post-randomization]
  • Medication Tolerability [Срок оценки: 12 weeks post-randomization]
  • Global Clinical Improvement [Срок оценки: 12 weeks post-randomization]

Критерии участия

Критерии включения

  • Diagnosis of a depressive disorder (major depressive disorder, depressive episode, or persistent depressive disorder) confirmed by a healthcare professional according to DSM-5 or ICD-10 criteria.
  • Aged 18 years or older at the time of enrollment.
  • Clinical indication for initiation or modification of antidepressant pharmacotherapy.
  • Ability to understand study procedures and provide written informed consent.

Критерии исключения

  • Inability to provide informed consent.
  • Current acute psychotic disorder, manic episode, or uncontrolled bipolar disorder.
  • Current pregnancy or breastfeeding.
  • Use of medications with clinically significant interactions with antidepressants.
  • Any severe medical condition that, in the opinion of the investigator, would compromise participant safety or study integrity.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Morocco · 1 центр
  • Ar-Razi Psychiatric Hospital, Ibn Sina University Hospital — Rabat

Идентификаторы

NCT: NCT07480486 · UM5-PGX-DEP-2025 · CERB-219-25

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗