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Набор скоро начнётся NCT07416747

GynMDD Add-On to Supportive Psychotherapy in Mild to Moderate Depression

Без фазы С лечением Depression Depression Disorder Depression in Adults

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: GynMDD, Placebo.
Кому может быть актуально
Состояния в реестре: Depression, Depression Disorder, Depression in Adults. Базовые параметры: 18 лет — 65 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
Франция
Следующий шаг
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Официальное название

Multicenter Interventional Real-world Study Evaluating the Impact of the Dietary Supplement GynMDD Administered as an add-on to Supportive Psychotherapy in Patients With Mild to Moderate Depression.

Обзор

The goal of this clinical trial is to learn whether the dietary supplement GynMDD, when taken as an add-on to supportive psychotherapy, can improve symptoms of mild to moderate depression in adults aged 18 to 65. The main questions it aims to answer are: Does adding GynMDD to supportive psychotherapy lead to a greater reduction in depressive symptoms (measured by the MADRS scale) compared with supportive psychotherapy plus placebo? Does the supplement also improve digestive well-being and influence gut microbiota profiles over the course of treatment? Researchers will compare patients receiving supportive psychotherapy + GynMDD to those receiving supportive psychotherapy + placebo to see if GynMDD provides additional benefits beyond standard care. Participants will: * Attend regular appointments with their general practitioner * Complete one supportive psychotherapy session per week for 8 weeks * Take a daily dose of GynMDD or placebo * Complete weekly self-assessment questionnaires on mood, digestive symptoms, and any side effects via a mobile app * Provide two stool samples (at the start and end of the study) for microbiota analysis

Вмешательства

  • Пищевая добавка GynMDD
    Dietary Supplement: GynMDD (Sorolys®) Daily 2.5 g stick for 8 weeks Includes L-glutamine, Cavacurmin®, and Lacticaseibacillus rhamnosus GG
  • Другое Placebo
    Placebo for 8 weeks Identical stick without active ingredients; β-carotene added for color

Первичные конечные точки

  • Change in MADRS Score [Срок оценки: Baseline (V0) to Week 8 (V2)]
Вторичные конечные точки (6)
  • Change in Digestive Symptom Score (WGO scale) [Срок оценки: Baseline (V0), Week 4 (V1), Week 8 (V2)]
  • Change in PHQ-9 Self-Reported Depression Score [Срок оценки: Weekly for 8 weeks]
  • Change in GSRS-IBS Digestive Symptom Score [Срок оценки: Weekly for 8 weeks]
  • Fecal Microbiota Metagenomic Profile (Shotgun Sequencing) [Срок оценки: Baseline (V0) and Week 8 (V2)]
  • Adverse Events Reporting [Срок оценки: Weekly until 8 week and at Week 4 (V1), Week 8 (V2)]
  • Proportion of participants requiring initiation of antidepressant therapy [Срок оценки: Up to Week 8 (V2)]

Критерии участия

Критерии включения

  • Adults aged 18 to 65 years, inclusive
  • The main reason for consultation is a suspected depressive episode
  • MADRS score between 15 and 34, indicating mild to moderate depression
  • No suicidal risk, defined as a score of 0 on item 10 of the MADRS scale
  • Body Mass Index (BMI) between 19 and 29 (inclusive)
  • Signed informed consent, confirming that the participant understands the purpose and requirements of the study and agrees to comply with the procedures (including scheduled supportive psychotherapy sessions)
  • Affiliation with the French national health insurance system or beneficiary of such coverage

Критерии исключения

  • History of severe psychiatric disorders or currently undergoing supportive psychotherapy
  • Confirmed suicidal risk, defined as a score between 1 and 6 on MADRS item 10
  • Current treatment with antidepressants (AD)
  • MADRS score > 34
  • Conditions in which probiotic administration is not recommended (e.g., immunodeficiency, presence of a venous catheter)
  • Allergy to any component of the placebo or the GynMDD dietary supplement
  • Current consumption of probiotic-based dietary supplements
  • Recent infectious episodes that may require antibiotic therapy
  • Current treatment with anxiolytics
  • Long-term chronic anti-inflammatory treatment
  • Alcohol abuse, defined as a consumption of 10 standard drinks per week or more
  • Use of illicit drugs or substances of abuse
  • Inability to provide informed consent
  • Participation in another clinical study within the past 12 months
  • Pregnant or breastfeeding women
  • Patients without health insurance
  • Individuals under legal protection, guardianship, trusteeship, or any other protective measure

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
Четверное слепое
Основная цель
Лечение

Центры проведения

Франция · 1 центр
  • Hôpital Albert Chenevier 40 rue de Mesly — Créteil

Идентификаторы

NCT: NCT07416747 · 2025-A00661-48 · 2025-A00661-48

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗