Treatment Response Biomarkers in MDD

NCT ID: NCT05585047

Last Updated: 2022-10-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 480 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-10
• Study Completion Date: 2026-08-31

Brief Summary

This experiment intends to explore the differences among various types of depression, as well as the differences between healthy subjects and depressed patients, and find possible biological markers from the severity of symptoms, social function and cognitive function of depressed patients, combined with EEG characteristics, biological test indicators (blood, faeces, hair, etc.) and functional magnetic resonance imaging data.

To explore the changes in clinical symptoms, cognitive and social functions, and biological indicators of various types of patients before and after treatment, to provide references for the prognosis of various types, and to predict the future development of the disease according to the baseline indicators of patients; According to the above aspects, this experiment can follow up the patients with depression, track their disease development, and study the potential biological changes in the early stage of the disease, which has the potential to reveal the pathogenesis and provide guidance for the early diagnosis and intervention of depression.

Detailed Description

More specifically, the goals of this study are to 1) explore the potential biomarkers for Major Depressive Disorder by comparing MDD patients and healthy controls; 2) investigate the biochemical indicators for subtypes of MDD through long-term cohort follow-up studies; 3) investigate the differences and similarities among different types of MDD patients in terms of cognitive functions, biological tests, as well as neuroimaging data; 4) evaluate and analyze the prognosis of patients according to the baseline level, and search for the biomarkers regarding MDD treatment response to guide the clinical treatment and intervention of patients with MDD; 5) Through the long-term follow-up study, the behavioural and biochemical indicators of the patients with MDD were collected, the differences between the indicators before and after remission were examined, and the state and quality of the pathophysiological indicators of the patients with MDD were investigated.

Conditions

Major Depressive Disorder

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. The subject is an outpatient/inpatient (but the subject who participated in the experimental treatment does not need to be hospitalized), and passed M.I.N.I. interview confirmed that the subjects met DSM-5 diagnostic criteria of current or past major depressive disorder.

2. Age 18-60 years old, regardless of gender;

3. Right-handed;

4. Junior high school education or above, capable of completing informed consent and cognitive test;

5. During the follow-up period, the subjects can take antidepressant treatment according to the doctor's advice of outpatient or resident.

-

Exclusion Criteria

1. Patients with psychotic symptoms;

2. M.I.N.I. was diagnosed as schizophrenia, schizophrenic affective disorder, schizophrenia-like disorder, Paranoia or current mental symptoms, post-traumatic stress disorder (currently or within the past year) or dysthymia;

3. with brain organic and serious physical diseases (such as thyroid disease, lupus erythematosus, diabetes, lung, liver and kidney) damage, infection, major trauma, etc.) exclude intracranial implants;

4. Clinically significant sensory disturbance that can't be corrected (for example, hearing impairment makes conversation impossible);

5. Pregnant and lactating women; -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhang Yan

OTHER

Sponsor Role: lead

Responsible Party

Zhang Yan

Deputy Director of the National Clinical Research Center for Mental Disorders

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

yan zhan, doctor

Role: CONTACT

yan.zhang@csu.edu.cn

13807315182

yumeng ju, doctor

Role: CONTACT

yumeng.ju@csu.edu.cn

19908463800

Facility Contacts

yan zhan, doctor

Role: primary

yan.zhang@csu.edu.cn

13807315182

yumeng ju, doctor

Role: backup

yumeng.ju@csu.edu.cn

19908463800

Other Identifiers

MDD202011

Identifier Type: -

Identifier Source: org_study_id