Efficacy and Safety of Probiotics for Anxiety Depression
ConditionAnxiety Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorMoon (Guangzhou) Biotechnology Co., Ltd.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Probiotic
- Placebo
- Escitalopram
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov