NCT03062332

Brief Summary

Background: The gut microbiome is emerging as an important factor in regulating mental health yet it remains unclear what the target should be for psychiatric treatment. Investigators aim at elucidating the complement of the gut microbiome community for individuals with Major Depressive disorder (MDD) and Bipolar disorder (BD) relative to controls, and test for relationships with symptoms. Methods: Investigators prospect to recruit subjects including patients and controls amount to 240. All subjects will be collected for blood and stool samples,assessed by clinical scales. Finally, analyzing the correlation among the metabolon in blood, microbiota in stool and clinical scales to obtain the possible interaction between diseases and gut microbiota.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
2.9 years until next milestone

Study Start

First participant enrolled

January 16, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

August 19, 2021

Status Verified

August 1, 2021

Enrollment Period

2.8 years

First QC Date

February 16, 2017

Last Update Submit

August 17, 2021

Conditions

Bipolar DisorderMajor Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Composition of the gut microbiota

    The relative richness of the species, %

    3 months

Secondary Outcomes (1)

  • metabolon

    3 months

Study Arms (6)

Bipolar disorder,mania

The group includes subjects who are diagnosed to mania episode of bipolar disorder.

Genetic: Faecal genome

Bipolar disorder,depressive

The group includes subjects who are diagnosed to depression episode of bipolar disorder.

Genetic: Faecal genome

Bipolar disorder,mixed

The group includes subjects who are diagnosed to mixed episode of bipolar disorder.

Genetic: Faecal genome

First episode major depression

The group includes subjects who are diagnosed to first episode of major depression.

Genetic: Faecal genome

major depression，recurrent

The group includes subjects who are diagnosed to recurrent episode of major depression.

Genetic: Faecal genome

Healthy control

The group includes subjects who are Healthy control.

Genetic: Faecal genome

Interventions

Faecal genomeGENETIC

Sequencing faecal genome is not the intervention measure.It is the Observational method to detect the component of faecal microbiota.

Bipolar disorder,depressiveBipolar disorder,maniaBipolar disorder,mixedFirst episode major depressionHealthy controlmajor depression，recurrent

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients are someone who are hospitalized in First Affiliated Hospital of Xi'an Jiaotong University. Healthy controls are healthy volunteers.

You may qualify if:

  • Conforms to the diagnosis of bipolar disorder or major depressive disorder.
  • Take antibiotics continuously less than 3 days in recent 3 months.
  • ≦BMI≦30
  • Age≦65

You may not qualify if:

  • who is diagnosed with physical diseases and other mental diseases.
  • pregnant or lactational women
  • who is diagnosed with mental retardation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiancang Ma

Xi'an, Shaanxi, 710061, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood and stool sample

MeSH Terms

Conditions

Bipolar DisorderDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersDepressive Disorder

Study Officials

  • Xiancang Ma, professor

    First Affiliated Hospital Xi'an Jiaotong University

    STUDY DIRECTOR

Central Study Contacts

Xiancang Ma, professor

CONTACT

13002951782maxiancang@163.com

Wei Wang

CONTACT

86-13991985805xianwv@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2017

First Posted

February 23, 2017

Study Start

January 16, 2020

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

August 19, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)