Poststroke Depression of Clinical Trial Registration
IFEPSDAIS
The Study on the Association of Intestinal Flora and Early Post-stroke Depression in Patients With Acute Ischemic Stroke
1 other identifier
observational
100
1 country
1
Brief Summary
The investigators aim to explore the relationship between gut microbiota composition and earlier poststroke depression via 16S rRNA sequencing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2019
Typical duration for all trials
1 active site
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
Study Start
First participant enrolled
January 20, 2019
CompletedFirst Submitted
Initial submission to the registry
February 24, 2019
CompletedFirst Posted
Study publicly available on registry
March 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2021
CompletedMarch 5, 2019
January 1, 2019
1.4 years
February 24, 2019
March 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
The Composition of Intestinal Microbial Communities Calculated by OTU Analysis
The composition were measured in number based on OTU data
2 weeks
The Diversity of Intestinal Microbial Communities Calculated by OTU Analysis
Community diversity measured in the Shannon index
2 weeks
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
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 Outcomes (1)
The Plasma Level of 5-Hydroxytryptamine( 5-HT) Neurotransmitter Using Enzyme-Linked Immunosorbent Assay ( ELISA) Methods
2 weeks
Study Arms (2)
Patients with poststroke depression
No intervention
Patients without poststroke depression
No intervention
Eligibility Criteria
acute ischemic stroke patients
You may qualify if:
- 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.
You may not qualify if:
- 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，
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yurong Zhang
Xi'an, Shaanxi, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yurong Zhang, PhD
First Affiliated Hospital Xi'an Jiaotong University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2019
First Posted
March 5, 2019
Study Start
January 20, 2019
Primary Completion
May 31, 2020
Study Completion
February 28, 2021
Last Updated
March 5, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share