Efficacy and Safety of Probiotics for Anxiety Depression

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (2)

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital of Guangdong Pharmaceutical University — Guangzhou

Identifiers

NCT: NCT07331987 · MN-MOOD-102

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗