Treatment Response Biomarkers in MDD

Major Depressive Disorder Clinical Trial

Official title:

Prospective Biomarkers for Treatment Response in Major Depressive Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05585047
• Other study ID #: MDD202011
• Status: Recruiting
• Start date: June 10, 2021
• Est. completion date: August 31, 2026

Study information

• Verified date: October 2022
• Source: Central South University
• Contact: yan zhan, doctor
• Phone: 13807315182
• Email: yan.zhang[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: August 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

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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; -

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Locations

Country	Name	City	State
China	Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Zhang Yan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Hamilton Depression Rating Scale-17 item (HAMD-17)Interview-based questionnaire used to measure the severity of depression.	Consists of 17 items with a score calculated. Higher scores are associated with more severe depression.	Baseline, 2weeks, 1 month, 2 months,4months,6months,1year
Secondary	Change in Hamilton Anxiety Rating Scale-14 item (HAMA-14)Interview-based questionnaire used to measure the severity of anxiety.	Consists of 14 items with a score calculated. Higher scores are associated with more severe anxiety.	Baseline, 2weeks, 1 month, 2 months,4months,6months,1year
Secondary	Change in DSST (Number of Correct Symbols)	Digit Symbol Substitution Test (DSST) is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than normal functioning) to 133 (greater than normal functioning)." as a description of DSST.	Baseline, 2weeks, 1 month, 2 months,4months,6months,1year
Secondary	Change in Generalized Anxiety Disorder-7 (GAD-7)	The GAD-7 aims to assesses the severity of anxious symptoms.	Baseline, 2weeks, 1 month, 2 months,4months,6months,1year
Secondary	Change in Patient Health Questionnaire-9 (PHQ-9)	The PHQ-9 aims to assesses the severity of depression symptoms.	Baseline, 2weeks, 1 month, 2 months,4months,6months,1year