Model-based Defining of Subtypes of Depression and Optimal Treatment: an Integrated Techniques Module.

Major Depressive Disorder Clinical Trial

Official title:

Model-based Defining of Subtypes of Depression and Optimal Treatment: an Integrated Techniques Module in Multidimensional Omics for Peripheral Biomarkers.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04518592
• Other study ID #: MDSDOT
• Status: Recruiting
• Start date: December 22, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: Shanghai Mental Health Center
• Contact: huafang Li, Phd
• Phone: 86-21-64387250
• Email: lhlh_5[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this proposal, the investigators aim to explore the clinical subtypes and biological markers to personalize the use of antidepressants in MDD. By stratifying the subjects with (versus without) remission and treatment response, the biological markers are expected to have important prediction effects in future clinical practice.

Description:

In this proposal, through the integration of genome, transcriptome, protein, metabolic group, microbial group and immune cell subtype of multidimensional omics data to construct the curative effect of forecast model.The investigators aim to explore the clinical subtypes and biological markers to personalize the use of antidepressants in MDD. By stratifying the subjects with (versus without) remission and treatment response, the biological markers are expected to have important prediction effects in future clinical practice.Ultimate aim is to solve the depression medication selection dilemma of "trial and error", reduce medical costs, improving depression treatment experience.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male or female subjects aged 18-65 years, outpatients or inpatients.

2. Meets the DSM-V criteria for Severe Major Depressive Disorder ; a single episode(296.21?296.22?296.23)or recurrent episode (296.31?296.32?296.33);

3. MADRS score greater than or equal to 24 in baseline;

4. HAMD-17 score greater than or equal to 20 in baseline.

5. Patients have learned and voluntarily participated in the study, and have to sign informed consent.

Exclusion Criteria:

1. Meets the DSM-V criteria for other mental disorder(schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, anxiety disorders, obsessive-compulsive and related disorders, somatic symptom and related disorders, etc ).

2. Patient has survived suicide attempt , or may have a significant risk for suicidal behavior ,or with a score of >3 on suicidal thoughts item 10 on the MADRS.

3. Depressive episode of an organic mental disorder secondary to a systemic disease or a central nervous system disease, such as depressive episode secondary to hypothyroidism.

4. Serious and instable body disease such as cerebrovascular disease, respiratory disease, blood disease, liver and kidney disease, disease of internal secretion, nervous system and other systemic disease.

5. any history of seizures or other organic brain diseases.

6. History of alcohol or drug abuse (besides nicotine) over the last 6 months

7. Serious and instable body disease such as cerebrovascular disease, liver and kidney disease, disease of internal secretion (abnormal thyroid function), blood disease; any history of seizures or other organic brain diseases.

8. Subjects who can't take drug or have an operation history which affect drug metabolism.

9. Clinically significant changes in ECG or laboratory tests, including >1.5X upper limit of normal liver function?over the limit of normal renal function and blood sugar?abnormal cardiac troponins?obvious abnormity in the thyroid function

10. Pregnant or lactating women and women of childbearing potential throughout the study period; men who have the desire of fertility within three months;

11. Participation in other clinical studies in the nearly 1 month before screen.

12. Other conditions which, in the investigator's judgment, render patients unsuitable for the clinical study.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reductive scores of Montgomery-Asberg Depression Rating Scale(MADRS)	change in MADRS scores from baseline and week 8	assess the scale at baseline and week 8.
Secondary	effective rate	ratio of points of Montgomery-Asberg Depression Rating Scale(MADRS) and/or Hamilton Depression Scale-17(HAMD-17)	assess the scale at baseline and week 8.
Secondary	Response rate	Montgomery-Asberg Depression Rating Scale(MADRS) = 10 and/or Hamilton Depression Scale-17(HAMD-17) =7	assess the scale at baseline and week 8.
Secondary	Montgomery-Asberg Depression Rating Scale(MADRS) scores	Montgomery-Asberg Depression Rating Scale(MADRS) scores at baseline and week 4, 8	assess the scale at baseline and week 4, 8.
Secondary	Subtraction score	Hamilton Depression Scale-17(HAMD17) total score after 8 weeks treatment compared with the baseline subtraction score.	assess the scale at baseline and week 4, 8.
Secondary	The overall evaluation of illness	the CGI-s (Clinical Global Impression scale - Severity of Illness)rating changes compared to the baseline and CGI - I score.	assess the scale at baseline and week 4, 8.
Secondary	Hamilton Anxiety Scale	the scores changes compared to the baseline	assess the scale at baseline and week 4, 8.
Secondary	The Pittsburgh Sleep Quality Index	the scores changes compared to the baseline	assess the scale at baseline and week 4, 8.
Secondary	The Montreal Cognitive Assessment	the scores changes compared to the baseline	assess the scale at baseline and week 4, 8.
Secondary	The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)	the scores changes compared to the baseline	assess the scale at baseline and week 4, 8.