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Идёт набор NCT07645157

Sertraline Combined With Multi-Strain Probiotics for Adolescent Depression

Фаза II С лечением Major Depressive Disorder (MDD) Probiotic Intervention

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: Sertraline.
Кому может быть актуально
Состояния в реестре: Major Depressive Disorder (MDD), Probiotic Intervention. Базовые параметры: 12 лет — 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Study on the Efficacy and Safety of Sertraline Combined With Multi-Strain Probiotics in Treating Adolescent Patients With Depression: A Multi-Center Randomized Controlled Clinical Trial

Обзор

The objective of this clinical trial is to evaluate the efficacy and safety of sertraline combined with multi-strain probiotics in adolescents aged 12-18 with major depressive disorder. The primary research question is whether sertraline combined with multi-strain probiotics is superior to sertraline combined with placebo in alleviating depressive symptoms and improving mood symptoms in adolescents. If there is a control group: researchers will compare sertraline combined with multi-strain probiotics with sertraline combined with placebo (a substance that looks similar but does not contain probiotics) to determine whether adding multi-strain probiotics provides greater therapeutic benefits for adolescent patients with depression. Participants will: 1. Undergo 8 weeks of treatment with sertraline combined with multi-strain probiotics or sertraline combined with placebo; 2. Have clinical visits every 4 weeks for clinical assessments and safety monitoring.

Вмешательства

  • Препарат Sertraline
    Weeks 1-4, the starting dose of sertraline is 25 mg/day, adjusted according to the clinical assessment of the psychiatrist, with a dosage range of 25-150 mg/day. By week 4, the sertraline dosage should reach at least 150 mg/day; placebo powder, 1 sachet/day.

Первичные конечные точки

  • Change in Children's Depression Rating Scale - Revised (CDRS-R) scores [Срок оценки: Assessments will be performed at baseline, week 4, and week 8]
Вторичные конечные точки (1)
  • Change in Baker Depression Scale#BDI# scores from baseline [Срок оценки: Assessments will be performed at baseline, week 4, and week 8]

Критерии участия

Критерии включения

  • • Aged 12-18 years
  • Meets DSM-5 criteria for major depressive disorder (MDD) and is currently in a depressive episode according to the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL) interviews
  • Child Depression Rating Scale-Revised (CDRS-R) score ≥40 at baseline
  • Clinical Global Impression Scale (CGI-S) score ≥ 4 at baseline

Критерии исключения

  • • Presence of any comorbid psychiatric disorder according to DSM-5, other than anxiety disorders
  • MDD with psychotic symptoms
  • Young Mania Rating Scale (YMRS) >13 at baseline
  • History of neurological disorders (e.g., epilepsy, traumatic brain injury), or the presence of serious physical illnesses (e.g., thyroid disease, lupus erythematosus, diabetes mellitus, clinically significant pulmonary, hepatic, or renal impairment, or major trauma)
  • Nonresponse to at least two antidepressants with different mechanisms, and each administered at an adequate dose and for an adequate duration
  • History of intolerance to sertraline or nonresponse to an adequate therapeutic course of sertraline
  • Current high suicide risk
  • History of alcohol or drug abuse or dependence
  • Taking or administering antidepressants within 5 half-lives
  • Use of probiotic-related food or medicine within 2 weeks before enrollment
  • Systemic use of antibiotics or antifungals within 1 month before enrollment
  • History of severe food allergy or known hypersensitivity to the Lactobacillus crispatus preparation or any of its components
  • Adherence to vegetarian or other restrictive dietary patterns
  • Pregnancy or breastfeeding

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

Китай · 1 центр
  • The Affiliated Hospital of Chongqing Medical University — Чунцин

Идентификаторы

NCT: NCT07645157 · ZZ2025-940-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗