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NCT Number: NCT05575713

The Effect of Soluble Epoxide Hydrolase (SEH) on Depression

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • Inclusion criteria:
  • Voluntarily sign informed consent;
  • Age: 18-65 years old;
  • Elementary school or above, able to understand and complete all inspections and assessments;
  • Did not take any psychotropic drugs (including benzodiazepines) within 2 weeks before enrollment;
  • After routine medical diagnosis by clinicians, they were divided into depression and healthy people.
  • Exclusion criteria:
  • Severe somatic or neurological diseases;
  • Mental retardation and dementia;
  • During pregnancy or breastfeeding;
  • Heavy smoking, alcoholism and other substance abuse or dependence (within 3 months before enrollment);
  • Electric shock treatment (within 3 months before enrollment);
  • According to the judgment of the investigator, it is not suitable to participate in this study.

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Oct 12, 2022
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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