Major Depressive DisorderIFMDDNCT04347577
Intestinal Flora and Major Depressive Disorders
An observational study of Major Depressive Disorder, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
As an important micro-ecological factor in human body, intestinal flora is closely related to the occurrence and development of major depressive disorder. The purpose of our study is to investigate a microbiome probe of depression. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- duloxetine
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2020to 1 Apr 2023
- Phase
- Observational
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: case : 30 patients of major depressive disorder Male or female participants ages 20-40 with Major Depressive Disorder, Intervention: Drug: duloxetine control：10 subjects without major depressive disorder
Who may be able to join
- The proportion between male and female in each of groups was 1:1
- Han Chinese
- Permanent resident population of Beijing
- Body Mass Index,18.5-23.9
- Signed informed consent
Who cannot join
- Other severe mental disease diagnosis
- Alcohol and other substance abuse or dependence
- Patients with contraindicated signs of duloxetine
- A history of clinically significant physical disorders, including any cardiovascular, liver, kidney, respiratory, blood, endocrine, and neurological disorders, as well as clinically significant laboratory abnormalities of unstable or expected therapeutic intervention during the study period
- The apparent risk of suicide and/or the patient is considered by the investigator to be at serious risk of suicide
- Patients who had received antibiotics, probiotics and hormones within one month
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, 100020
Hui Shi, Doctor, 08613810427166, dlshihui@163.com
About this study
Official title: Investigation Into the Diversity and Dynamic Succession of Gut Flora Pre- and Post-remission in Major Depressive Disorder
As an important micro-ecological factor in human body, intestinal flora is closely related to the occurrence and development of major depressive disorder. The purpose of our study is to investigate a microbiome probe of depression. This study is a 6-months open trial that will enroll approximately 30 patients in major depressive disorders and 10 age- and sex-matched healthy controls. We will comparing gut bacteria community structures of pre- treatment, those of 1 month and 6 months after treatment to remission. With the microbiome change in a preliminary analysis of pre-and post-treatment, we will reveal the diversity before and after the depression treatment.
Read the detailed description
Participants (30 patients and 10 controls) will be recruited in the clinical psychological department of Beijing Chaoyang hospital. Patients with first-episode major depressive disorder confirmed by structured diagnostic interview (Chinese mini version) and assessment of symptom severity (Hamilton Depression Scale-17, HAMD-17) will be enrolled in a six-month open study. Healthy controls matched for age, sex and body-mass index (BMI) will have only baseline stool and electroencephalography (EEG) collections. We then will make an assessment of HAMD-17, patient-reported outcomes, and EEGs identified at the pre-treatment and those same parameters at the 1- to 6-month point. Treatment response (50% reduction in HAMD-17), treatment remission (HAMD-17<7, at least 3 weeks) will be analyzed with change in microbiome, inflammation markers and EEG.
We will analyze the differences in the intestinal flora community structure and diversity of patients and controls in order to obtain information on key different bacteria. We will conduct the correlation between each genus of bacteria in the intestinal flora and the total score of HAMD-17 in order to reveal the dynamic succession change of the intestinal flora with the disease state of major depressive disorder. The analysis with multiple testing corrections will be analyzed between depressive severity, EEG and gut microbiome composition.
The results of this study will provide the objective and direct biomarkers for major depressive disorder to achieve remission. This study will bring an important scientific basis to further optimizing treatment methods and improvie clinical effect.
- Conditions
- Major Depressive Disorder
- Being tested
- duloxetine
- Keywords
- major depressive disorder, Intestinal flora, remission
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duloxetineDrug
Also called cymbalta
open-label study
What is being measured
The primary outcome is the main question the study is designed to answer.
the difference between the flora
The potential differences in the microbiome between depressed patients and healthy controls
Measured: pre-treatment
Secondary outcomes (1)
the dynamic succession change of the intestinal flora
correlation between each genus of bacteria in the intestinal flora and the total score of HAMD-17
Measured: 0-1-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start10 Apr 2020
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Apr 2023 (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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Capital Medical University
- Responsible party
- Principal investigator, Hui Shi, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347577
- Sponsor's protocol ID
- HShi
- Acronym
- IFMDD
- Status last verified
- Apr 2020
- First submitted
- 11 Apr 2020
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Into the Diversity and Dynamic Succession of Gut Flora Pre- and Post-remission in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT04347577
- Acronym / sponsor ID
- IFMDD / HShi
- Conditions
- Major Depressive Disorder
- Keywords
- major depressive disorder, Intestinal flora, remission
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Collaborators
- Capital Medical University
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 15 Apr 2020 (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.
As an important micro-ecological factor in human body, intestinal flora is closely related to the occurrence and development of major depressive disorder. The purpose of our study is to investigate a microbiome probe of depression. This study is a 6-months open trial that will enroll approximately 30 patients in major depressive disorders and 10 age- and sex-matched healthy controls. We will comparing gut bacteria community structures of pre- treatment, those of 1 month and 6 months after treatment to remission. With the microbiome change in a preliminary analysis of pre-and post-treatment, we will reveal the diversity before and after the depression treatment.
Detailed description
Participants (30 patients and 10 controls) will be recruited in the clinical psychological department of Beijing Chaoyang hospital. Patients with first-episode major depressive disorder confirmed by structured diagnostic interview (Chinese mini version) and assessment of symptom severity (Hamilton Depression Scale-17, HAMD-17) will be enrolled in a six-month open study. Healthy controls matched for age, sex and body-mass index (BMI) will have only baseline stool and electroencephalography (EEG) collections. We then will make an assessment of HAMD-17, patient-reported outcomes, and EEGs identified at the pre-treatment and those same parameters at the 1- to 6-month point. Treatment response (50% reduction in HAMD-17), treatment remission (HAMD-17<7, at least 3 weeks) will be analyzed with change in microbiome, inflammation markers and EEG.
We will analyze the differences in the intestinal flora community structure and diversity of patients and controls in order to obtain information on key different bacteria. We will conduct the correlation between each genus of bacteria in the intestinal flora and the total score of HAMD-17 in order to reveal the dynamic succession change of the intestinal flora with the disease state of major depressive disorder. The analysis with multiple testing corrections will be analyzed between depressive severity, EEG and gut microbiome composition.
The results of this study will provide the objective and direct biomarkers for major depressive disorder to achieve remission. This study will bring an important scientific basis to further optimizing treatment methods and improvie clinical effect.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- case : 30 patients of major depressive disorder Male or female participants ages 20-40 with Major Depressive Disorder, Intervention: Drug: duloxetine control：10 subjects without major depressive disorder
Key inclusion criteria (5 listed)
- The proportion between male and female in each of groups was 1:1
- Han Chinese
- Permanent resident population of Beijing
- Body Mass Index,18.5-23.9
- Signed informed consent
Key exclusion criteria (6 listed)
- Other severe mental disease diagnosis
- Alcohol and other substance abuse or dependence
- Patients with contraindicated signs of duloxetine
- A history of clinically significant physical disorders, including any cardiovascular, liver, kidney, respiratory, blood, endocrine, and neurological disorders, as well as clinically significant laboratory abnormalities of unstable or expected therapeutic intervention during the study period
- The apparent risk of suicide and/or the patient is considered by the investigator to be at serious risk of suicide
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 |
|---|---|---|
| duloxetineAlso: cymbaltaopen-label study | Drug | – |
Primary outcome
the difference between the flora
Time frame: pre-treatment
The potential differences in the microbiome between depressed patients and healthy controls
1 secondary outcome
the dynamic succession change of the intestinal flora
Time frame: 0-1-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Beijing Chao Yang Hospital at 1 site in China.
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 5 inclusion and 6 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 17 Apr 2020. 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 China. 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. 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 Hui Shi, Doctor (086-13810427166, dlshihui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the difference between the flora (time frame: pre-treatment). 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 17 Apr 2020.