Major Depressive DisorderNCT05575713
The Effect of Soluble Epoxide Hydrolase (SEH) on Depression
An observational study of Major Depressive Disorder, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with major depressive disorder in the outpatient department of psychiatry and psychology of Nanfang Hospital
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
About this study
Official title: The Predictive Effect of Soluble Epoxide Hydrolase (SEH) on Depression Treatment, Cognition and Suicide Improvement
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Keywords
- depression, cognition, suicide, Soluble epoxide hydrolase，sEH, prediction
- Medical subject headings
- Depressive Disorder, Major, Depression, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Major depressive disorder | Patients diagnosed with severe depressive episode according to the diagnostic and Statistical Manual of mental disorders, 5th Edition (DSM-V); | |
| healthy volunteer | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Depression Scale (HAMD-24)
Scores ranging from 0-76, with higher scores indicate more severe symptoms
Measured: Baseline, the second week, the first month, the second month, the third month, the sixth month and the first year
Secondary outcomes (1)
Change in Columbia-Suicide Severity Rating Scale, C-SSRS
Scores ranging from 0-42, with higher scores indicate more severe symptoms
Measured: Baseline, the second week, the first month, the second month, the third month, the sixth month and the first year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start1 Jun 2019
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Honglei Yin, doctor, Study chair, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575713
- Sponsor's protocol ID
- NFEC-2022-092
- Status last verified
- Nov 2024
- First submitted
- 28 Aug 2022
- Last updated
- 18 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zheng S, Guo J, Zheng R, Ji Y, Zhong Q, Yin H. A Naturalistic Prospective Study of the Prognostic Impact of EPHX2 in Major Depressive Disorder: Impulsivity may be an Important Factor. Depress Anxiety. 2025 Apr 13;2025:8124403. doi: 10.1155/da/8124403. eCollection 2025.
PubMed 40259894Zheng S, Zeng W, Wu Q, Li W, He Z, Li E, Tang C, Xue X, Qin G, Zhang B, Yin H. Predictive Models for Suicide Attempts in Major Depressive Disorder and the Contribution of EPHX2: A Pilot Integrative Machine Learning Study. Depress Anxiety. 2024 May 9;2024:5538257. doi: 10.1155/2024/5538257. eCollection 2024.
PubMed 40226652Ji Y, Liu X, Zheng S, Zhong Q, Zheng R, Huang J, Yin H. Validation and application of the Chinese version of the Columbia-Suicide Severity Rating Scale: Suicidality and cognitive deficits in patients with major depressive disorder. J Affect Disord. 2023 Dec 1;342:139-147. doi: 10.1016/j.jad.2023.09.014. Epub 2023 Sep 14.
PubMed 37714386
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Effect of Soluble Epoxide Hydrolase (SEH) on Depression Treatment, Cognition and Suicide Improvement
- ClinicalTrials.gov ID
- NCT05575713
- Acronym / sponsor ID
- NFEC-2022-092
- Conditions
- Major Depressive Disorder
- Keywords
- depression, cognition, suicide, Soluble epoxide hydrolase，sEH, prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Major depressive disorder | – | –Patients diagnosed with severe depressive episode according to the diagnostic and Statistical Manual of mental disorders, 5th Edition (DSM-V); |
| healthy volunteer | – | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with major depressive disorder in the outpatient department of psychiatry and psychology of Nanfang Hospital
Key inclusion criteria (5 listed)
Key exclusion criteria (6 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Derived from this study: PubMed 40259894Zheng S, Guo J, Zheng R, Ji Y, Zhong Q, Yin H. A Naturalistic Prospective Study of the Prognostic Impact of EPHX2 in Major Depressive Disorder: Impulsivity may be an Important Factor. Depress Anxiety. 2025 Apr 13;2025:8124403. doi: 10.1155/da/8124403. eCollection 2025.
- Derived from this study: PubMed 40226652Zheng S, Zeng W, Wu Q, Li W, He Z, Li E, Tang C, Xue X, Qin G, Zhang B, Yin H. Predictive Models for Suicide Attempts in Major Depressive Disorder and the Contribution of EPHX2: A Pilot Integrative Machine Learning Study. Depress Anxiety. 2024 May 9;2024:5538257. doi: 10.1155/2024/5538257. eCollection 2024.
- Derived from this study: PubMed 37714386Ji Y, Liu X, Zheng S, Zhong Q, Zheng R, Huang J, Yin H. Validation and application of the Chinese version of the Columbia-Suicide Severity Rating Scale: Suicidality and cognitive deficits in patients with major depressive disorder. J Affect Disord. 2023 Dec 1;342:139-147. doi: 10.1016/j.jad.2023.09.014. Epub 2023 Sep 14.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Honglei Yin, doctor study chair
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05575713, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.