Efficacy and Safety of Probiotics for Anxiety Depression
Recruiting · NCT07331987 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 60 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
2 locations listed.
- The First Affiliated Hospital of Guangdong Pharmaceutical University - Guangzhou, Guangdong, China
- The First Affiliated Hospital of Guangdong Pharmaceutical University - Guangzhou, Guangdong, China