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Multimodal Pharmacological Study of Clinical Cohorts for Major Depressive Disorder

Multimodal Pharmacological Study of Clinical Cohorts for Major Depressive Disorder - Sub-task 2: A Longitudinal Imaging-Proteomics Study on Suicidal Tendency and Mechanisms of Rapid Antidepressant Effects

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07602153
Enrollment
130
Registered
2026-05-22
Start date
2026-05-30
Completion date
2027-12-31
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder (MDD

Brief 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.

Interventions

It does not interfere with specific clinical treatment decisions but observes patients under different treatment paths: ECT, Esketamine nasal spray, or conventional antidepressants.

Sponsors

Shanghai Mental Health Center
Lead SponsorOTHER
Lingang National Laboratory
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Change in the total score of the Hamilton Depression Rating Scale (HAMD-17) from baseline to follow-up.From enrollment to the end of treatment at 8 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026