The Effect of Soluble Epoxide Hydrolase (SEH) on Depression

Major Depressive Disorder Clinical Trial

Official title:

The Predictive Effect of Soluble Epoxide Hydrolase (SEH) on Depression Treatment, Cognition and Suicide Improvement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05575713
• Other study ID #: NFEC-2022-092
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

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