Efficacy and Safety of Probiotics for Anxiety Depression

Официальное название

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Clinical Efficacy and Safety of Probiotics in Participants With Anxiety Depression

Обзор

This randomized, double-blind, placebo-controlled study will enroll 60 individuals with mild-to-moderate anxiety depression. Following a 3-month intervention and a 1-month follow-up period, the study aims to: 1) evaluate the efficacy of probiotics by comparing anxiety, depression, and sleep scores to baseline; and 2) investigate the safety and underlying mechanisms by analyzing changes in serum biomarkers, gut microbiota, and related metabolites.

Вмешательства

• Препарат Probiotic
  Participants receive Probiotic product once daily by oral, 60B CFU/day for 3 months.
• Препарат Placebo
  Participants receive Placebo once daily by oral for 3 months.
• Комбинированный продукт Escitalopram
  Participants receive Escitalopram Oxalate Tablets once daily by oral, 10mg/day for 3 months.

Первичные конечные точки

• Hamilton Depression Rating Scale (HAM-D-24) [Срок оценки: Baseline, Day 30, Day 90, Day 120 (follow up)]
• Hamilton Anxiety Rating Scale (HAM-A) [Срок оценки: Baseline, Day 30, Day 90, Day 120 (follow up)]

Вторичные конечные точки (2)

• The Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline, Day 30, Day 90, Day 120 (follow up)]
• Gastrointestinal Symptom Rating Scale (GSRS) [Срок оценки: Baseline, Day 30, Day 90, Day 120 (follow up)]

Критерии участия

Критерии включения

• 1\) Age: 18-60 years old; Gender: male or female.
• 2\) Meets the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) for a mild-to-moderate depressive or anxiety symptoms.
• 3\) Hamilton Depression Rating Scale (HAM-D-24) score ≥ 8 or Hamilton Anxiety Rating Scale (HAM-A-14) score ≥ 7 at screening.
• 4\) Has no used of anxiolytic or antidepressant medications (including traditional Chinese patent medicines), with the exception of Escitalopram Oxalate, within 2 weeks prior to the first dose.
• 5\) For participants of childbearing potential (male or female): Must agree to use least one medically approve form of contraception (e.g., intrautering device \[IUD\], oral contraceptives, or condoms) throughout the trial. For female participants of childbearing potential: Must have a negative urine pregnancy test at screening and must be non-lactating.
• 6\) The participant is willing and be able to provide written informed consent to participate in the study.

Критерии исключения

• 1\) HAM-D-24 score ≥ 35 or HAM-A-14 score ≥ 29.
• 2\) Presence of significant suicidal ideation.
• 3\) History or current diagnosis of neuropsychiatric disorders such as schizophrenia or epilepsy.
• 4\) History of head trauma (with loss of consciousness for >10 minutes), other unstable major somatic diseases, or any somatic condition that could cause psychiatric symptoms.
• 5\) Suspected intellectual disability.
• 6\) History of alcohol or substance abuse prior to enrollment.
• 7\) Cranial magnetic resonance imaging (MRI) reveals organic lesions.
• 8\) Participants who are deemed unsuitable for the study by the investigator for any other reason.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Guangdong Pharmaceutical University — Гуанчжоу

Идентификаторы

NCT: NCT07331987 · MN-MOOD-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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