Treatment Response Biomarkers in MDD

NCT05585047 | Recruiting

• 1 other identifier: MDD202011
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Treatment Response; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Change in Hamilton Depression Rating Scale-24 item (HAMD-24)Interview-based questionnaire used to measure the severity of depression

  Consists of 24 items with a score calculated. Higher scores are associated with more severe depression.

  8weeks

Secondary Outcomes (5)

• Change in Hamilton Depression Rating Scale-17 item (HAMD-17)Interview-based questionnaire used to measure the severity of depression.

  Baseline, 2weeks, 1 month, 2 months，4months，6months，1year

• Change in Hamilton Anxiety Rating Scale-14 item (HAMA-14)Interview-based questionnaire used to measure the severity of anxiety.

  Baseline, 2weeks, 1 month, 2 months，4months，6months，1year

• Change in DSST (Number of Correct Symbols)

  Baseline, 2weeks, 1 month, 2 months，4months，6months，1year

• Change in Generalized Anxiety Disorder-7 (GAD-7)

  Baseline, 2weeks, 1 month, 2 months，4months，6months，1year

• Change in Patient Health Questionnaire-9 (PHQ-9)

  Baseline, 2weeks, 1 month, 2 months，4months，6months，1year

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Samples are taken from depressed patients in outpatient and inpatient departments of hospitals and recruited health care workers. 480 subjects are expected to be collected and divided into two groups, 180 healthy subjects and 300 experimental subjects.

You may qualify if:

• 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.
• Age 18-60 years old, regardless of gender;
• Right-handed;
• Junior high school education or above, capable of completing informed consent and cognitive test;
• During the follow-up period, the subjects can take antidepressant treatment according to the doctor's advice of outpatient or resident.

You may not qualify if:

• Patients with psychotic symptoms;
• 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;
• 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;
• Clinically significant sensory disturbance that can't be corrected (for example, hearing impairment makes conversation impossible);
• Pregnant and lactating women; -

Sponsors & Collaborators

• Zhang Yan: lead

Study Sites (1)

Central South University

Changsha, Hunan, 410001, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral venous blood，Faecal sample，hair

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

yan zhan, doctor

CONTACT

13807315182; yan.zhang@csu.edu.cn

yumeng ju, doctor

CONTACT

19908463800; yumeng.ju@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director of the National Clinical Research Center for Mental Disorders

Study Record Dates

• First Submitted: October 15, 2022
• First Posted: October 18, 2022
• Study Start: June 10, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: October 19, 2022

Record last verified: 2022-10

Locations

CN (1)