Intestinal Flora and Major Depressive Disorders

NCT04347577 | Unknown FDA Drug

• 1 other identifier: HShi
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Major Depressive Disorder

Keywords

major depressive disorder; Intestinal flora; remission

Outcome Measures

Primary Outcomes (1)

• the difference between the flora

  The potential differences in the microbiome between depressed patients and healthy controls

  pre-treatment

Secondary Outcomes (1)

• the dynamic succession change of the intestinal flora

  0-1-6 months

Interventions

duloxetine DRUG

open-label study

Also known as: cymbalta

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead
• Capital Medical University: collaborator

Study Sites (1)

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Hui Shi, Doctor

CONTACT

086-13810427166; dlshihui@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: deputy director

Study Record Dates

• First Submitted: April 11, 2020
• First Posted: April 15, 2020
• Study Start: April 10, 2020
• Primary Completion: October 1, 2022
• Study Completion: April 1, 2023
• Last Updated: April 17, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)