Depression
Conditions
Brief summary
The purpose of this clinical trial is to learn if Bifidobacterium has antidepressant-like effects by enhancing creatine absorption in adults. The main questions to be answered are Does Bifidobacterium combined with creatine have better antidepressant effects? Does Bifidobacterium enhance exogenous creatine uptake? Researchers will compare bifidobacterium combined with creatine with placebo to see if bifidobacterium combined with creatine has antidepressant effects. Participants will: Take bifidobacterium, creatine or placebo every day for 4 weeks. Keep a diary of their symptoms and collect blood samples.
Interventions
DIETARY_SUPPLEMENTCreatine
The dosing schedule of creatine administration is 3 g daily for 4 weeks, and administration of a placebo.
DIETARY_SUPPLEMENTBifidobacterium and creatine
The dosing schedule of creatine administration is 3 g daily for 4 weeks. In parallel, the dosing schedule of bifidobacterium administration is 200 million colony-forming units (CFU) /day for 4 weeks.
DIETARY_SUPPLEMENTPlacebo
Administration of creatine placebo and bifidobacterium placebo for 4 weeks,
Sponsors
Zhujiang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
for depression: * Adults age 18-60 years inclusive. * Current diagnosis of major depression disorder (MDD) identified by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (SCID-5). * Current Hamilton Depression Scale 17 score of \> 16. * BMI (body Mass Index) between 18 and 28 kg/m² * Right-handed
Exclusion criteria
* Diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder, identified by the SCID-5. * History of or current diagnosis of acute kidney injury (AKI), chronic kidney disease (CKD) or end-stage renal disease (ESRD) * History of seizure disorder * Current serious suicide risk identified by the Columbia Severity Suicide Rating Scale * Previous diagnosis of creatine deficiency syndrome or evidence of creatine deficiency syndrome * Antibiotic use in last 30 days * Probiotics use in last 30 days * Positive pregnancy test * Breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Hamilton Depression Rating Scale | 4 weeks | Comparison of Hamilton Depression Rating Scale before and after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in creatine level in blood | 4 weeks | Comparison of creatine level in blood before and after treatment |
Countries
China
Outcome results
None listed