Poststroke Depression of Clinical Trial Registration

NCT ID: NCT03863951

Last Updated: 2019-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-20
• Study Completion Date: 2021-02-28

Brief Summary

The investigators aim to explore the relationship between gut microbiota composition and earlier poststroke depression via 16S rRNA sequencing.

Detailed Description

In this study, patients with first ever acute ischemic stroke were studied. According to the psychological assessment, patients were divided into two groups according to whether or not there was a PSD at the earlier stage of stroke. Clinical biological data and blood and feces samples were collected. Firstly, 16srDNA sequencing was used to study the difference in the composition and diversity of intestinal microbial communities in the two groups of patients. Then the two groups selected individual representative samples and conducted macro genome sequencing. At the same time, by analyzing the correlation between the intestinal flora and the clinical risk factors and neurotransmitters in early PSD patients, the key functional bacteria related to PSD were identified.

Conditions

Stroke; Depression

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with poststroke depression

No intervention

No interventions assigned to this group

Patients without poststroke depression

No intervention

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• diagnosed with the first ever acute ischemic stroke occurring within 2 weeks and were confirmed by CT or MRI,
• has no history of depression or use of antidepressants or antipsychotics,
• were competent to consent to take part in this research.

Exclusion Criteria

• significant acute or severe illness such as infection,heart failure and tumor,
• previous diagnosis of depression or other mental disorder or who had recently accepted antidepressants or antipsychotics,
• antibiotics in the last two weeks,
• severe aphasia or dysarthria,irritable bowel syndrome,asthma,and pregnant or lactating women,
• a previous history of neurological illness including AD and PD，
• Inflammatory bowel disease，

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yurong Zhang, PhD

Role: STUDY_CHAIR

First Affiliated Hospital Xi'an Jiaotong University

Locations

Yurong Zhang

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yurong Zhang, PhD

Role: CONTACT

zhangyurong72@mail.xjtu.edu.cn

0086-029-85323443

Facility Contacts

Yurong Zhang

Role: primary

zhangyurong72@mail.xjtu.edu.cn

Other Identifiers

XJTU1AF-CRF-2018-024

Identifier Type: -

Identifier Source: org_study_id