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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Major Depressive Disorder

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: huafang Li, Phd; Phone Number: 3128 86-21-64387250; Email: lhlh_5@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Mental Health Center
      • Contact: Huafang Li, PH.D; Phone Number: 86-2134773128; Email: lhlh_5@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Enrollment is constrained to those participants dosed with SSRI/SNRI and healthy controls.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Severe Major Depressive Disorder; subjects who meet the standards;using conventional antidepressant.
control , healthy; subjects who meet the standards;gender, race, and level of education matched healthy people

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
Hamilton Anxiety Scale	the scores changes compared to the baseline	assess the scale at baseline and week 4, 8.
The Pittsburgh Sleep Quality Index	the scores changes compared to the baseline	assess the scale at baseline and week 4, 8.
The Montreal Cognitive Assessment	the scores changes compared to the baseline	assess the scale at baseline and week 4, 8.
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.

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Investigators: Study Chair: huafang Li, Phd, Study Principal Investigator Drug Clinical Trial Office, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2020
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: August 16, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: MDSDOT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No