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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05575713
Other study ID # NFEC-2022-092
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date June 2023

Study information

Verified date August 2022
Source Nanfang Hospital of Southern Medical University
Contact Honglei Yin, doctor
Phone 13710401435
Email yinhonglei1981@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Depression is the most common mental disease and the second leading cause of chronic disease burden, which is closely related to suicidal behavior. The diagnosis and treatment of depression still lack of effective biological indicators, and about 30% of patients with depression still can not relieve their depressive symptoms after treatment. Previous studies have found that ATP release from astrocytes plays an important role in the occurrence, development and treatment of depression. Epoxy eicosotrienes (eets) are closely related to the function of the nervous system and may be the pathophysiological mechanism of depression. Soluble epoxide hydrolase (SEH) can regulate ATP release by affecting EET degradation, leading to depression like behavior and antidepressant effect, and sEH is closely related to cognitive function of depression.


Description:

This study is an observational study without any intervention treatment for the subjects. All subjects need to sign the informed consent before screening, and the successful subjects can enter the study. Routine clinical diagnosis and treatment were performed on patients with depression, and the treatment effect of depressive symptoms, neurocognitive function and suicide improvement were evaluated at the 2nd week, 1st, 2nd, 3rd, 6th and 12th months after enrollment, and statistical analysis was conducted. The treatment lasted until the subjects completed the 12th month follow-up or reached any of the withdrawal criteria. This study will clarify the relationship between sEH gene polymorphism and mRNA expression and depression and suicide behavior, and explore the predictive role of soluble epoxide hydrolase sEH in the treatment effect of depression, cognition and suicide improvement during the follow-up study.


Recruitment information / eligibility

Status Recruiting
Enrollment 330
Est. completion date June 2023
Est. primary completion date June 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility - Inclusion criteria: 1. Voluntarily sign informed consent; 2. Age: 18-65 years old; 3. Elementary school or above, able to understand and complete all inspections and assessments; 4. Did not take any psychotropic drugs (including benzodiazepines) within 2 weeks before enrollment; 5. After routine medical diagnosis by clinicians, they were divided into depression and healthy people. - Exclusion criteria: 1. Severe somatic or neurological diseases; 2. Mental retardation and dementia; 3. During pregnancy or breastfeeding; 4. Heavy smoking, alcoholism and other substance abuse or dependence (within 3 months before enrollment); 5. Electric shock treatment (within 3 months before enrollment); 6. According to the judgment of the investigator, it is not suitable to participate in this study.

Study Design


Locations

Country Name City State
China Nanfang Hospital, Southern Medical University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Hamilton Depression Scale (HAMD-24) Scores ranging from 0-76, with higher scores indicate more severe symptoms Baseline, the second week, the first month, the second month, the third month, the sixth month and the first year
Secondary Change in Columbia-Suicide Severity Rating Scale, C-SSRS Scores ranging from 0-42, with higher scores indicate more severe symptoms Baseline, the second week, the first month, the second month, the third month, the sixth month and the first year
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