Not Yet RecruitingNot Applicable

Multimodal Pharmacological Study of Clinical Cohorts for Major Depressive Disorder

130 participantsStarted 2026-05-30

Plain-language summary

This study focuses on the neurobiological changes in MDD patients with high suicidal risk during rapid antidepressant treatments, such as Esketamine and Electroconvulsive Therapy (ECT). Core ObjectivesEstablish a standardized longitudinal cohort for high-risk suicidal populations to ensure high-quality data for clinical transformation. Investigate the biological mechanisms of rapid-acting interventions by analyzing changes in brain function and molecular pathways. Develop predictive biomarkers to identify treatment responders early, thereby reducing ineffective trial-and-error treatments and lowering suicide risk. Methodology \& Data CollectionThe study integrates multi-dimensional data across three critical time points: T0 (Baseline), T1 (Acute Phase/24h post-first treatment), and T2 (Remission Phase/4-6 weeks). Sample Cohort: A total of 130 participants (70 ECT, 30 Esketamine, 30 conventional medication). Multimodal Data Integration:Clinical Phenotyping: Standardized scales including HAMD-17 (Primary Indicator), C-SSRS (Suicide Assessment), and QIDS-SR16. Biological Omics: Whole Genome Sequencing (WGS), single-cell sequencing, proteomics, metabolomics, DNA methylomics, and gut metagenomics. Neuroimaging \& Physiology: Functional MRI (fMRI), Diffusion Tensor Imaging (DTI), and 32-channel resting-state EEG. SignificanceBy capturing dynamic "treatment-response" trajectories, the project aims to move beyond descriptive symptoms to a system biology-based diagnosis. The findings are expected to provide scientific evidence for individualized intervention strategies and improve the efficiency of care for patients with treatment-resistant depression and acute suicidal ideation.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Age 18-65; Han Chinese; meets DSM-5 criteria for MDD; suicidal ideation (HAMD-17 Item 3 score ≥ 2); education above primary school; provided written informed consent. Exclusion Criteria: Other major mental disorders; unstable physical diseases (cardiovascular, hepatic, etc.); pregnancy or lactation; contraindications to Ketamine or ECT; history of drug or alcohol abuse within 6 months.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study is listed as 'not yet recruiting' — do you know when it's expected to open, and would it make sense for me to wait for it or start a different treatment now?
2Since this trial is listed as Phase NA, can you help me understand what kind of study this actually is — is it testing a new drug, comparing existing medications, or mainly observing how people respond to current treatments?
3The trial is measuring changes in the Hamilton Depression Rating Scale score — can you explain what that scale measures and how meaningful a change in that score would be for my day-to-day life?
4Before I consider this study, is there a standard antidepressant treatment you'd recommend trying first, and how would that compare to what this trial is offering?
5What would my commitment look like if I eventually enrolled in this study — how many visits, how long is the follow-up period, and what monitoring would be involved??

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in the total score of the Hamilton Depression Rating Scale (HAMD-17) from baseline to follow-up.

Timeframe: From enrollment to the end of treatment at 8 weeks

Trial details

NCT IDNCT07602153

SponsorShanghai Mental Health Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More Major Depressive Disorder (MDD trials