Efficacy and Safety of Probiotics for Anxiety Depression

NCT07331987 · tracked via the Priya Life Science China tracker

Sponsor

Moon (Guangzhou) Biotechnology Co., Ltd

Phase

Not applicable

Started

2026-06-15

Last updated

2026-06-29

Condition(s) studied

Anxiety Depression

Investigational drug(s) / intervention(s)

ProbioticPlaceboEscitalopram

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

Placebo: Participants receive Placebo once daily by oral for 3 months.

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

60 Years

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Hamilton Depression Rating Scale (HAM-D-24) — Baseline, Day 30, Day 90, Day 120 (follow up)
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.
Hamilton Anxiety Rating Scale (HAM-A) — Baseline, Day 30, Day 90, Day 120 (follow up)
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.

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of Guangdong Pharmaceutical University	Guangzhou	Guangdong	Recruiting

On this site

📄 Lexapro (escitalopram) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07331987 on ClinicalTrials.gov ↗ ← All trials in China