Anxiety DepressionNCT07331987
Efficacy and Safety of Probiotics for Anxiety Depression
A study testing Probiotic and Escitalopram in people with Anxiety Depression, run by Moon (Guangzhou) Biotechnology Co., Ltd. at 1 site in China.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anxiety Depression
- What is being tested?
- Probiotic and Escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong
IRB, First Affiliated Hosp, Guangdong Pharm Univ, 86-020-87609616, gylunli@163.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Clinical Efficacy and Safety of Probiotics in Participants With Anxiety Depression
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.
- Conditions
- Anxiety Depression
- Being tested
- Probiotic, Placebo, Escitalopram
- Keywords
- Depression, Anxiety, Mood, Probiotics
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDrug
Participants receive Probiotic product once daily by oral, 60B CFU/day for 3 months.
PlaceboDrug
Participants receive Placebo once daily by oral for 3 months.
EscitalopramCombination product
Participants receive Escitalopram Oxalate Tablets once daily by oral, 10mg/day for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Placebo + Escitalopram | Placebo comparator | Not described Receives: Drug: Placebo; Combination Product: Escitalopram |
| Probiotics + Escitalopram | Experimental | Not described Receives: Drug: Probiotic; Combination Product: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 30, Day 90, Day 120 (follow up)
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.
Measured: Baseline, Day 30, Day 90, Day 120 (follow up)
Secondary outcomes (2)
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.
Measured: Baseline, Day 30, Day 90, Day 120 (follow up)
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.
Measured: Baseline, Day 30, Day 90, Day 120 (follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start15 Jun 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moon (Guangzhou) Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331987
- Sponsor's protocol ID
- MN-MOOD-102
- Status last verified
- Jun 2026
- First submitted
- 30 Dec 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Clinical Efficacy and Safety of Probiotics in Participants With Anxiety Depression
- ClinicalTrials.gov ID
- NCT07331987
- Acronym / sponsor ID
- MN-MOOD-102
- Conditions
- Anxiety Depression
- Keywords
- Depression, Anxiety, Mood, Probiotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Moon (Guangzhou) Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo + Escitalopram | Placebo comparator | Drug: Placebo, Combination Product: Escitalopram |
| Probiotics + Escitalopram | Experimental | Drug: Probiotic, Combination Product: Escitalopram |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticParticipants receive Probiotic product once daily by oral, 60B CFU/day for 3 months. | Drug | Probiotics + Escitalopram |
| PlaceboParticipants receive Placebo once daily by oral for 3 months. | Drug | Placebo + Escitalopram |
| EscitalopramParticipants receive Escitalopram Oxalate Tablets once daily by oral, 10mg/day for 3 months. | Combination product | Placebo + Escitalopram, Probiotics + Escitalopram |
Primary outcome
Hamilton Depression Rating Scale (HAM-D-24)
Time frame: Baseline, Day 30, Day 90, Day 120 (follow up)
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.
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: Baseline, Day 30, Day 90, Day 120 (follow up)
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.
2 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic and Escitalopram in people with Anxiety Depression, run by Moon (Guangzhou) Biotechnology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Baojia Huang (86-020-31603387, huangbj@moonbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (HAM-D-24) (time frame: Baseline, Day 30, Day 90, Day 120 (follow up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.