Multimodal Pharmacological Study of Clinical Cohorts for Major Depressive Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Therapeutic intervention.
- Who it may be relevant to
- Registry conditions: Major Depressive Disorder (MDD. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
- Drug Therapeutic intervention
It does not interfere with specific clinical treatment decisions but observes patients under different treatment paths: ECT, Esketamine nasal spray, or conventional antidepressants.
Primary outcome measures
- Change in the total score of the Hamilton Depression Rating Scale (HAMD-17) from baseline to follow-up. [Time frame: From enrollment to the end of treatment at 8 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07602153 · LGL-5858-02