PB-18 Probiotic for Mild to Moderate Depression
ConditionDepressive Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFirst Affiliated Hospital of Zhejiang University
About this trial
The goal of this clinical trial is to learn if Bifidobacterium PB-18 can treat mild to moderate depressive disorder in adults aged 18 to 65 years who are not taking antidepressants or other psychotropic medications during the study. It will also learn about the safety of Bifidobacterium PB-18 and explore its potential effects on the gut-brain axis. The main questions it aims to answer are:
Does Bifidobacterium PB-18 increase the response rate at Week 8, defined as a reduction of at least 50% from baseline in the 17-item Hamilton Depression Rating Scale (HAMD-17)?
What adverse events occur in participants receiving Bifidobacterium PB-18?
How do gut microbiota, metabolite profiles, and related biological markers change after treatment with Bifidobacterium PB-18?
Researchers will compare Bifidobacterium PB-18 with a placebo, a look-alike powder that does not contain PB-18, to see if Bifidobacterium PB-18 improves depressive symptoms.
Participants will:
Be randomly assigned to receive Bifidobacterium PB-18 or placebo in a 1:1 ratio Take the assigned study product once daily for 8 weeks Visit the study site at baseline, Week 4, and Week 8 for symptom and safety assessments Complete study questionnaires, including HAMD-17, HAMA, PSQI, and CBCT Provide blood and stool samples at baseline and Week 8 for exploratory biological analyses
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Outpatient or inpatient participants, aged 18 to 65 years (inclusive), of any sex
Current episode meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for depressive disorder
Baseline score on the 17-Item Hamilton Depression Rating Scale is 7 to 24, inclusive
No concomitant use of antidepressants or other psychotropic medications during the study
Disqualifiers
Current or past diagnosis, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria, of bipolar disorder, schizophrenia spectrum and other psychotic disorders, neurocognitive disorders, neurodevelopmental disorders, or substance-related and addictive disorders
Presence of significant psychotic symptoms, such as delusions or hallucinations
Severe or unstable diseases of the central nervous system, cardiovascular system, respiratory system, liver, kidneys, endocrine system, hematologic system, or other systems that, in the investigator's judgment, make the participant unsuitable for the study
Evident suicide risk, defined as a score of 1 or higher on the suicide item of the 17-Item Hamilton Depression Rating Scale
Trial design
Design model
Parallel
Treatments tested in this trial
Bifidobacterium
Dietary supplementParticipants receive Bifidobacterium PB-18 powder orally once daily for 8 weeks. Each daily dose contains 1 × 10\^10 CFU of PB-18. The study product is administered from baseline through Week 8.
Placebo
Other interventionParticipants receive a matching placebo powder orally once daily for 8 weeks. The placebo is maltodextrin and matches the PB-18 product in dose schedule, appearance, color, smell, taste, packaging, and administration, but does not contain PB-18.
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: Bifidobacterium PB-18Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Response Rate at Week 8 Based on the 17-Item Hamilton Depression Rating Scale
Between-group difference in response rate at Week 8. Response is defined as a reduction of at least 50 percent from baseline in the total score on the 17-Item Hamilton Depression Rating Scale. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
Time frame
Week 8Secondary outcomes
1
Remission Rate at Week 8 Based on the 17-Item Hamilton Depression Rating Scale
Between-group difference in remission rate at Week 8. Remission is defined as a total score of 7 or less on the 17-Item Hamilton Depression Rating Scale. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
Time frame
Week 82
Response Rate at Week 4 Based on the 17-Item Hamilton Depression Rating Scale
Between-group difference in response rate at Week 4. Response is defined as a reduction of at least 50 percent from baseline in the total score on the 17-Item Hamilton Depression Rating Scale. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
Time frame
Week 43
Remission Rate at Week 4 Based on the 17-Item Hamilton Depression Rating Scale
Between-group difference in remission rate at Week 4. Remission is defined as a total score of 7 or less on the 17-Item Hamilton Depression Rating Scale. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
Time frame
Week 44
Change From Baseline in Total Score on the 17-Item Hamilton Depression Rating Scale
Change from baseline in the total score on the 17-Item Hamilton Depression Rating Scale at follow-up visits. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
Time frame
Baseline, Week 4, and Week 8Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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