Efficacy and Safety of Probiotics for Anxiety Depression

NCT07331987 | Not Yet Recruiting

• 1 other identifier: MN-MOOD-102
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety Depression

Keywords

Depression; Anxiety; Mood; Probiotics

Outcome Measures

Primary Outcomes (2)

• Hamilton Depression Rating Scale (HAM-D-24)

  Depression symptoms will be assessed using the 24-item Hamilton Depression Rating Scale (HAM-D-24) at baseline and the specified time points during the study. With higher scores indicating more severe depression, and scores categorized as \<8 non-depressed, 8-19 mild, 20-34 moderate, ≥35 severe for diagnosis and monitoring treatment response.

  Baseline, Day 30, Day 90, Day 120 (follow up)

• Hamilton Anxiety Rating Scale (HAM-A)

  Anxiety symptoms will be evaluated using 14-item Hamilton Anxiety Rating Scales (HAM-A) at baseline and the specified time point during the study. Each item is scored on a scale of 0 (not present) to 4 (severe). The total score, calculated by summing all items, ranges from 0 to 56, with higher scores indicating greater anxiety severity, where 0-7 indicates no/minimal, 8-14 mild, 15-23 moderate and ≥24 severe.

  Baseline, Day 30, Day 90, Day 120 (follow up)

Secondary Outcomes (2)

• The Pittsburgh Sleep Quality Index (PSQI)

  Baseline, Day 30, Day 90, Day 120 (follow up)

• Gastrointestinal Symptom Rating Scale (GSRS)

  Baseline, Day 30, Day 90, Day 120 (follow up)

Study Arms (2)

Placebo + Escitalopram

PLACEBO COMPARATOR

Drug: Placebo; Combination Product: Escitalopram

Probiotics + Escitalopram

EXPERIMENTAL

Drug: Probiotic; Combination Product: Escitalopram

Interventions

Probiotic DRUG

Participants receive Probiotic product once daily by oral, 60B CFU/day for 3 months.

Probiotics + Escitalopram

Placebo DRUG

Participants receive Placebo once daily by oral for 3 months.

Placebo + Escitalopram

Escitalopram COMBINATION_PRODUCT

Participants receive Escitalopram Oxalate Tablets once daily by oral, 10mg/day for 3 months.

Placebo + Escitalopram; Probiotics + Escitalopram

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \) Age: 18-60 years old; Gender: male or female.
• \) 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.
• \) Hamilton Depression Rating Scale (HAM-D-24) score ≥ 8 or Hamilton Anxiety Rating Scale (HAM-A-14) score ≥ 7 at screening.
• \) 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.
• \) 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.
• \) The participant is willing and be able to provide written informed consent to participate in the study.

You may not qualify if:

• \) HAM-D-24 score ≥ 35 or HAM-A-14 score ≥ 29.
• \) Presence of significant suicidal ideation.
• \) History or current diagnosis of neuropsychiatric disorders such as schizophrenia or epilepsy.
• \) 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.
• \) Suspected intellectual disability.
• \) History of alcohol or substance abuse prior to enrollment.
• \) Cranial magnetic resonance imaging (MRI) reveals organic lesions.
• \) Participants who are deemed unsuitable for the study by the investigator for any other reason.

Sponsors & Collaborators

• Moon (Guangzhou) Biotechnology Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Probiotics; Escitalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Baojia Huang

CONTACT

+86-15588105007; huangbj@moonbio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 12, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

CN (1)