The Predictive Effect of Soluble Epoxide Hydrolase (SEH) on Depression Treatment, Cognition and Suicide Improvement
Conditions: Major Depressive Disorder
Sponsor: Nanfang Hospital, Southern Medical University

PROTOCOL
Title: The Predictive Effect of Soluble Epoxide Hydrolase (SEH) on Depression
Treatment, Cognition and Suicide Improvement
Version/Date:
V1.0/20220525
Contacts:
Honglei Yin, +8613710401435, yinhonglei1981@163.com
Location:
Department of psychiaty, Nanfang hospital, Southern medical university

Study Description
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 Design
Study Type :
Observational
Estimated Enrollment :
330 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Target Follow-Up Duration:
12 Months
Official Title:
The Predictive Effect of Soluble Epoxide
Hydrolase (SEH) on Depression Treatment,
Cognition and Suicide Improvement
Actual Study Start Date :
June 2019
Estimated Primary Completion Date :
June 2023
Groups and Cohorts
Outcome Measures
Primary Outcome Measures :

Change in Hamilton Depression Scale (HAMD-24) [Time Frame: 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 :
Change in Columbia-Suicide Severity Rating Scale, C-SSRS [Time Frame: 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
Eligibility Criteria
Study Population
Major depressive disorder:
Patients with major depressive disorder in the outpatient department of psychiatry and
psychology of Nanfang Hospital.
Patients diagnosed with severe depressive episode according to the diagnostic and
Statistical Manual of mental disorders, 5th Edition (DSM-V);
healthy volunteer:
Healthy volunteer group was recruited by advertisement。
Person who did not meet the DSM-V diagnosis of any mental disease, had no family
history of psychiatric disease, and had no history of suicidal behavior.
Criteria
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.