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

NCT04518592 | Recruiting

• 1 other identifier: MDSDOT
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• effective rate

  assess the scale at baseline and week 8.

• Response rate

  assess the scale at baseline and week 8.

• Montgomery-Asberg Depression Rating Scale(MADRS) scores

  assess the scale at baseline and week 4, 8.

• Subtraction score

  assess the scale at baseline and week 4, 8.

• The overall evaluation of illness

  assess the scale at baseline and week 4, 8.

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Male or female subjects aged 18-65 years, outpatients or inpatients.
• 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）；
• MADRS score greater than or equal to 24 in baseline；
• HAMD-17 score greater than or equal to 20 in baseline.
• Patients have learned and voluntarily participated in the study, and have to sign informed consent.

You may not qualify if:

• 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 ).
• 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.
• 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.
• 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.
• any history of seizures or other organic brain diseases.
• History of alcohol or drug abuse (besides nicotine) over the last 6 months
• 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.
• Subjects who can't take drug or have an operation history which affect drug metabolism.
• 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
• Pregnant or lactating women and women of childbearing potential throughout the study period; men who have the desire of fertility within three months;
• Participation in other clinical studies in the nearly 1 month before screen.
• Other conditions which, in the investigator's judgment, render patients unsuitable for the clinical study.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Related Publications (2)

• Zheng Y, Zeng D, Tian Y, Li S, He S, Li H. A network-based approach to discover diagnostic metabolite markers associated with depressive features for major depressive disorder. Front Psychiatry. 2025 Jun 6;16:1610520. doi: 10.3389/fpsyt.2025.1610520. eCollection 2025.

  PMID: 40547126 DERIVED

• Zheng Y, Zhang L, He S, Xie Z, Zhang J, Ge C, Sun G, Huang J, Li H. Integrated Module of Multidimensional Omics for Peripheral Biomarkers (iMORE) in patients with major depressive disorder: rationale and design of a prospective multicentre cohort study. BMJ Open. 2022 Nov 23;12(11):e067447. doi: 10.1136/bmjopen-2022-067447.

  PMID: 36418119 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

The participants' blood samples and stool samples will be collected for further study.

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• huafang Li, Phd

  Study Principal Investigator Drug Clinical Trial Office, Shanghai Mental Health Center

  STUDY CHAIR

Central Study Contacts

huafang Li, Phd

CONTACT

86-21-64387250; lhlh_5@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2020
• First Posted: August 19, 2020
• Study Start: December 22, 2020
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

CN (1)