The Effect of Soluble Epoxide Hydrolase (SEH) on Depression

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT05575713
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2022-08-28
• Study First Submitted QC: 2022-10-07
• Study First Posted: 2022-10-12
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Hamilton Depression Scale (HAMD-24)	Baseline, the second week, the first month, the second month, the third month, the sixth month and the first year	Scores ranging from 0-76, with higher scores indicate more severe symptoms

Secondary Outcome Measures

Name	Time	Method
Change in Columbia-Suicide Severity Rating Scale, C-SSRS	Baseline, the second week, the first month, the second month, the third month, the sixth month and the first year	Scores ranging from 0-42, with higher scores indicate more severe symptoms

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China