Probiotics for Anxiety and Depression: Side by Side with an Antidepressant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled study will enroll 60 adults with mild-to-moderate anxiety and/or depression. Participants will be assigned to probiotic, placebo, or escitalopram, with a 3-month intervention and 1-month follow-up. The researchers will measure changes in anxiety and depression scores, sleep, and safety, and will explore possible mechanisms by analyzing serum biomarkers, gut microbiota, and related metabolites. The trial aims to determine if probiotics can help improve symptoms and what biological changes accompany any improvement.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Guangdong Pharmaceutical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Baojia Huang
• Email: huangbj@moonbio.com
• Phone: 86-020-31603387

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.