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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Probiotic
DrugParticipants receive Probiotic product once daily by oral, 60B CFU/day for 3 months.
Placebo
DrugParticipants receive Placebo once daily by oral for 3 months.
Escitalopram
Combination productParticipants receive Escitalopram Oxalate Tablets once daily by oral, 10mg/day for 3 months.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Placebo + EscitalopramPlacebo comparator 2 interventions
Group B: Probiotics + EscitalopramExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Hamilton Depression Rating Scale (HAM-D-24)
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.
Time frame
Baseline, Day 30, Day 90, Day 120 (follow up)2
Hamilton Anxiety Rating Scale (HAM-A)
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.
Time frame
Baseline, Day 30, Day 90, Day 120 (follow up)Secondary outcomes
1
The Pittsburgh Sleep Quality Index (PSQI)
Assesses sleep quality from baseline to end of the study by questionnaire of The Pittsburgh Sleep Quality Index (PSQI). There are 19 items that are used to generate 7 component scores, which then are added together to determine a global score that ranges between 0 to 21, where higher scores reflect worse sleep quality.
Time frame
Baseline, Day 30, Day 90, Day 120 (follow up)2
Gastrointestinal Symptom Rating Scale (GSRS)
Assessment of gastrointestinal symptoms will conducted at baseline and throughout the study period. The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
Time frame
Baseline, Day 30, Day 90, Day 120 (follow up)Sponsors and contacts
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Source ClinicalTrials.gov