Major Depressive DisorderNCT04199845
8-week of PS128 RCT in Patients With Major Depressive Disorder
A study testing PS128 in people with Major Depressive Disorder, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- PS128
- 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 siteTaiwan
- Study dates
- 28 Aug 2019to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Chun-Hsin Chen, MD contact
Taiwan1 site, 1 recruiting
- Recruiting
WanFang Hospital, Taipei Medical University
Taipei, 116
Chun-Hsin Chen, MD, 886-2-29307930 ext. 53961, chunhsin57@yahoo.com.tw
Chun-Hsin Chen, MD
About this study
Official title: Psychophysiological Effects of Lactobacillus Plantarum PS128 in Patients With Major Depressive Disorder :an 8-week Double-blind, Placebo-controlled Trial
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.
Read the detailed description
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.
- Conditions
- Major Depressive Disorder
- Being tested
- PS128
- Keywords
- probiotics, gut permeability, inflammation
- Medical subject headings
- Depressive Disorder, Major, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PS128Dietary supplement
PS128 or placebo will be given twice daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: PS128 |
| placebo | Placebo comparator | Placebo containing starch will be given twice daily for 8 weeks. Receives: Dietary Supplement: PS128 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Hamilton Depression Rating Scale- 17 items (HAMD-17)
HAMD-17 to evaluate the severity of depression
Measured: baseline, week 2, week 4 and week 8.
Secondary outcomes (8)
Changes of Depression and Somatic Symptoms Scale (DSSS)
DSSS to evaluate the severity of depression
Measured: baseline, week 2, week 4 and week 8.
Changes of serum zonulin
use serum zonulin and I-FABP to represent gut permeability
Measured: baseline and week 8
Changes of serum IFABP
use serum I-FABP to represent gut permeability
Measured: baseline and week 8
Changes of serum hs-CRP level
inflammation markers
Measured: baseline and week 8
Changes of serum IL-6 level
inflammation markers
Measured: baseline and week 8
Changes of serum IL-10 level
inflammation markers
Measured: baseline and week 8
Changes of serum TNF-alpha level
inflammation markers
Measured: 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.
Measured: baseline and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start28 Aug 2019
- Primary completionMay 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Hsin Chen, MD, Principal investigator, TMU-Wan Fang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199845
- Sponsor's protocol ID
- N201906056
- Status last verified
- Aug 2019
- First submitted
- 10 Dec 2019
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychophysiological Effects of Lactobacillus Plantarum PS128 in Patients With Major Depressive Disorder :an 8-week Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04199845
- Acronym / sponsor ID
- N201906056
- Conditions
- Major Depressive Disorder
- Keywords
- probiotics, gut permeability, inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 28 Aug 2019 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 16 Dec 2019 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PS128 | Experimental | Dietary Supplement: PS128PS128 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. |
| placebo | Placebo comparator | Dietary Supplement: PS128Placebo containing starch will be given twice daily for 8 weeks. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| PS128PS128 or placebo will be given twice daily for 8 weeks. | Dietary supplement | PS128, placebo |
Primary outcome
Changes of Hamilton Depression Rating Scale- 17 items (HAMD-17)
Time frame: baseline, week 2, week 4 and week 8.
HAMD-17 to evaluate the severity of depression
8 secondary outcomes
Changes of Depression and Somatic Symptoms Scale (DSSS)
Time frame: baseline, week 2, week 4 and week 8.
Changes of serum zonulin
Time frame: baseline and week 8
Changes of serum IFABP
Time frame: baseline and week 8
Changes of serum hs-CRP level
Time frame: baseline and week 8
Changes of serum IL-6 level
Time frame: baseline and week 8
Changes of serum IL-10 level
Time frame: baseline and week 8
Changes of serum TNF-alpha level
Time frame: baseline and week 8
Changes of composition of gut microbiota
Time frame: baseline and week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- Individual participant dataSharing planned: No
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
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. This study is not recruiting at the moment.
Chun-Hsin Chen, MD contact
Chun-Hsin Chen, MD principal investigator
TMU-Wan Fang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PS128 in people with Major Depressive Disorder, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 4 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: status not confirmed, as of the sponsor's last update on 19 Dec 2019. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chun-Hsin Chen, MD (886-970-746395, chunhsin57@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Hamilton Depression Rating Scale- 17 items (HAMD-17) (time frame: baseline, week 2, week 4 and week 8.). 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 19 Dec 2019.