NCT07602153Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 130 (estimated)
- First submitted
- 17 May 2026
- Start date
- 30 May 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Shanghai Mental Health Center
- Diseases
- Depression
- NCT number
- NCT07602153
What you commit to
- Study type: Observational
- Planned participants: 130
- From 30 May 2026 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.