An interventional study of PS128 in Major Depressive Disorder, sponsored by Taipei Medical University WanFang Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-12-19.
Sponsored by Taipei Medical University WanFang Hospital · Not applicable, Interventional, and Treatment
Background: Recent studies have suggested that gut-brain axis may be one of the mechanisms of major depression disorder. In animal studies, alteration of gut microbiota can affect animal's depression or anxiety-like behavior, brain neurochemistry and inflammation. In human studies, the composition of gut microbiota is different between patients with MDD and healthy controls. In addition, supplementation of probiotics can improve mood status in community and clinical participants. In preliminary open trial, the investigators found PS-128 can significantly reduce depression severity in patients with MDD. Therefore, the investigators would like to conduct an 8-week randomized, double-blind, placebo controlled trial of PS-128 in patients with MDD.
Aims: This study will be an 8-week randomized, double-blind, placebo-controlled trial to investigate the effects of Lactobacillus plantarum PS128 on psychophysiology in patients with MDD.
Method: This is a two-phase study. In the first phase, the investigators will recruited patients fulfilling the following inclusion criteria: Age 20-65; fulfill Diagnostic and Statistical Manual of Mental Disorders fifth version (DSM-V) criteria of major depressive episode in recent 2 years; Psychotropics including antidepressants, antipsychotics and hypnotics have been kept unchanged for at least 1 months. The exclusion criteria are: comorbid with schizophrenia, bipolar disorder, or other substance use (except tobacco) disorder; having active suicidal or homicidal ideation; known allergy to probiotics; comorbid with diabetes mellitus, irritable bowel syndrome, inflammatory bowl disease, liver cirrhosis, or autoimmune diseases; known active bacterial, fungal, or viral infections in one month; use of antibiotics, steroid, immunosuppressants, probiotics, or synbiotics in the month before collecting blood and fecal samples; pregnant or lactating women; who state to have dietary pattern changed or in diet within previous two months. Those with HAMD-17 >=14 in the first screen will be randomized to PS-128 or placebo, with the ratio of 1:1, in the second phase intervention. In the second phase intervention, the investigators will give eligible patients Lactobacillus plantarum PS128 or placebo for 8 weeks, and compare depression symptoms, gut microbiota, gut permeability, and serum inflammation level before and after intervention.
The eligible patients will be randomly assigned to either active (PS128) or identical-appearing placebo capsule in an 1 : 1 ratio. A research assistant who is blind to the status of participants will conduct the randomization allocation. Recruited patients will be randomized in 1:1 ratio, by a computer-generated allocation sequence with blocks of 4. Patients, caregivers, and investigators will be all masked to the assignment. To ensure the concealment of the randomization assignment, active drug and placebo will be provided by coded containers. At the end of the first year, the investigators will temporarily decode the blinded medication to analyze the preliminary results.
Active capsule containing 300 mg of probiotics, equivalent to 3x10\^10 CFU of Lactobacillus plantarum PS128. PS128 and placebo will be manufactured by BENED biomedical and packed by a GMP pharmaceutical manufacture. PS128 or placebo will be provided twice, in the morning and in the afternoon, daily. Because activity and diet may alter composition of gut microbiota, the investigators will ask eligible patients not to change their lifestyle or diet pattern. In addition, though effects of psychotropics on inflammation are still controversial (Baumeister et al. 2016b), medications will be kept unchanged during the intervention period. If kinds of psychotropic were changed because of worsening clinical condition, the patient will be withdrawal from the study. However, if only dose of psychotropics were change, the investigators will record the changes, and the patients will be still kept in the study.
2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 2,338 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Taipei Medical University WanFang Hospital is the lead sponsor of 200 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
PS128 will be given twice daily for 8 weeks Active capsule containing 300 mg of probiotics, equivalent to 3 x10\^10 CFU of Lactobacillus plantarum PS128.
Dietary Supplement: PS128
Placebo containing starch will be given twice daily for 8 weeks.
Dietary Supplement: PS128
PS128 or placebo will be given twice daily for 8 weeks.
Changes of Hamilton Depression Rating Scale- 17 items (HAMD-17)
HAMD-17 to evaluate the severity of depression
Time frame: baseline, week 2, week 4 and week 8.
Changes of Depression and Somatic Symptoms Scale (DSSS)
DSSS to evaluate the severity of depression
Time frame: baseline, week 2, week 4 and week 8.
Changes of serum zonulin
use serum zonulin and I-FABP to represent gut permeability
Time frame: baseline and week 8
Changes of serum IFABP
use serum I-FABP to represent gut permeability
Time frame: baseline and week 8
Changes of serum hs-CRP level
inflammation markers
Time frame: baseline and week 8
Changes of serum IL-6 level
inflammation markers
Time frame: baseline and week 8
Changes of serum IL-10 level
inflammation markers
Time frame: baseline and week 8
Changes of serum TNF-alpha level
inflammation markers
Time frame: baseline and week 8
Changes of composition of gut microbiota
The investigators will compare the difference of alpha diversity and relative abundance in phylum level, family level, and genus level before and after 8-week PS128 intervention.
Time frame: baseline and week 8
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2019 (actual). Primary completion is estimated for May 2022, 33 months after the start.
Of 612 non-industry interventional studies with no phase under Depressive Disorder, Major, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 33 months is close to that.
Counting every sponsor, half of 652 studies reached it within 30 months; a quarter within 16 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lactiplantibacillus plantarum PS128
Taipei Medical University WanFang Hospital →