8-week of PS128 RCT in Patients With Major Depressive Disorder

NCT04199845 | Unknown DMC

• 1 other identifier: N201906056
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder

Keywords

probiotics; gut permeability; inflammation

Outcome Measures

Primary Outcomes (1)

• Changes of Hamilton Depression Rating Scale- 17 items (HAMD-17)

  HAMD-17 to evaluate the severity of depression

  baseline, week 2, week 4 and week 8.

Secondary Outcomes (8)

• Changes of Depression and Somatic Symptoms Scale (DSSS)

  baseline, week 2, week 4 and week 8.

• Changes of serum zonulin

  baseline and week 8

• Changes of serum IFABP

  baseline and week 8

• Changes of serum hs-CRP level

  baseline and week 8

• Changes of serum IL-6 level

  baseline and week 8

Study Arms (2)

PS128

EXPERIMENTAL

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

PLACEBO COMPARATOR

Placebo containing starch will be given twice daily for 8 weeks.

Dietary Supplement: PS128

Interventions

PS128 DIETARY_SUPPLEMENT

PS128 or placebo will be given twice daily for 8 weeks.

PS128; placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 one month
• HAMD-17 \>= 14

You may not qualify if:

• Comorbid with schizophrenia, bipolar disorder, or other substance use (except tobacco) disorder.
• having active suicidal or homicidal ideation
• known allergy to probiotics
• comorbid with hypertension, 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 (by history)
• who obviously change dietary pattern or in diet within previous month

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

WanFang Hospital, Taipei Medical University

Taipei, 116, Taiwan

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Inflammation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chun-Hsin Chen, MD

  TMU-Wan Fang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Hsin Chen, MD

CONTACT

886-970-746395; chunhsin57@yahoo.com.tw

Chun-Hsin Chen, MD

CONTACT

chunhsin57@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 16, 2019
• Study Start: August 28, 2019
• Primary Completion: May 1, 2022
• Study Completion: July 1, 2022
• Last Updated: December 19, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)