Poststroke Depression of Clinical Trial Registration

• Conditions: Stroke; Depression

• Registration Number: NCT03863951
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Study Timeline

• Status Verified: 2019-01
• Study Start: 2019-01-20
• Study First Submitted: 2019-02-24
• Study First Submitted QC: 2019-03-04
• Last Update Submitted: 2019-03-04
• Study First Posted: 2019-03-05
• Last Update Posted: 2019-03-05
• Primary Completion: 2020-05-31
• Study Completion: 2021-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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，

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Diversity of Intestinal Microbial Communities Calculated by OTU Analysis	2 weeks	Community diversity measured in the Shannon index
The Poststroke Depression Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score	3 months	Mild depression（HAMD-17 Score\>7，≤17）, moderate depression（HAMD-17 Score\>17，≤24）, major depression（HAMD-17 Score\>24）
The Composition of Intestinal Microbial Communities Calculated by OTU Analysis	2 weeks	The composition were measured in number based on OTU data
Functional Independence Assessed by Modified Rankin Scale (mRS）score	3 months	MRS score range from 0 to 6. Favourable outcome (mRS score≤2), worse outcome (mRS score\>2), and death (mRS score = 6).

Secondary Outcome Measures

Name	Time	Method
The Plasma Level of 5-Hydroxytryptamine( 5-HT) Neurotransmitter Using Enzyme-Linked Immunosorbent Assay ( ELISA) Methods	2 weeks	5-HT measured in mmol/L

Trial Locations

Locations (1)

Yurong Zhang; 🇨🇳 Xi'an, Shaanxi, China