Poststroke Depression of Clinical Trial Registration

Stroke Clinical Trial

— IFEPSDAIS  

Official title:

The Study on the Association of Intestinal Flora and Early Post-stroke Depression in Patients With Acute Ischemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03863951
• Other study ID #: XJTU1AF-CRF-2018-024
• Status: Recruiting
• Start date: January 20, 2019
• Est. completion date: February 28, 2021

Study information

• Verified date: January 2019
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Yurong Zhang, PhD
• Phone: 0086-029-85323443
• Email: zhangyurong72[@]mail.xjtu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 28, 2021
• Est. primary completion date: May 31, 2020
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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,

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Stroke

Locations

Country	Name	City	State
China	Yurong Zhang	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Composition of Intestinal Microbial Communities Calculated by OTU Analysis	The composition were measured in number based on OTU data	2 weeks
Primary	The Diversity of Intestinal Microbial Communities Calculated by OTU Analysis	Community diversity measured in the Shannon index	2 weeks
Primary	The Poststroke Depression Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score	Mild depression(HAMD-17 Score>7,=17), moderate depression(HAMD-17 Score>17,=24), major depression(HAMD-17 Score>24)	3 months
Primary	Functional Independence Assessed by Modified Rankin Scale (mRS)score	MRS score range from 0 to 6. Favourable outcome (mRS score=2), worse outcome (mRS score>2), and death (mRS score = 6).	3 months
Secondary	The Plasma Level of 5-Hydroxytryptamine( 5-HT) Neurotransmitter Using Enzyme-Linked Immunosorbent Assay ( ELISA) Methods	5-HT measured in mmol/L	2 weeks