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Poststroke Depression of Clinical Trial Registration (IFEPSDAIS)

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Xi'an Jiaotong University

Status

Unknown

Conditions

Stroke
Depression

Study type

Observational

Funder types

Other

Identifiers

NCT03863951
XJTU1AF-CRF-2018-024

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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,

Trial design

100 participants in 2 patient groups

Patients with poststroke depression
Description:
No intervention
Patients without poststroke depression
Description:
No intervention

Trial contacts and locations

1

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Central trial contact

Yurong Zhang, PhD

Data sourced from clinicaltrials.gov

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