NCT07735143Not yet recruiting
iMORE+ Study: A Multi-Omics Cohort Study of Major Depressive Disorder
iMORE+ Study: An Enhanced Prospective Observational Cohort Study of Major Depressive Disorder Integrating Longitudinal Clinical Characterization and Multi-Omics Profiling
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
Major depressive disorder (MDD) is a common mental health condition characterized by substantial clinical heterogeneity and variability in treatment response. Current diagnosis and treatment selection for MDD mainly rely on clinical assessments, and reliable biological markers that can support diagnosis, predict antidepressant treatment response, guide personalized treatment, and improve understanding of disease mechanisms remain limited. The goal of this prospective observational cohort study is to develop and optimize multi-omics-based models for MDD diagnosis and antidepressant treatment response prediction using longitudinal clinical characteristics and biological data collected from an independent prospective cohort. The study also aims to evaluate the generalizability and predictive performance of existing multi-omics-based models in this independent cohort of participants aged 14-45 years. The main questions it aims to answer are: Can integrated clinical and multi-omics features identify biomarkers and develop predictive models for MDD diagnosis and antidepressant treatment response? Can existing multi-omics-based models for MDD diagnosis and treatment response prediction be replicated and validated in an independent prospective cohort? Participants with MDD and healthy controls will undergo standardized clinical assessments, longitudinal follow-up, and biological sample collection for multi-omics profiling. Clinical and multi-omics data will be integrated to identify biomarkers, develop and validate predictive models for MDD diagnosis, antidepressant treatment response, and long-term outcomes, and explore biological pathways and potential therapeutic targets associated with MDD. The study is expected to improve understanding of the biological heterogeneity of MDD and contribute to the development of objective approaches for diagnosis, treatment response prediction, personalized care, and future therapeutic discovery.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 20 Jul 2026
- Start date
- 1 Sept 2027
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Shanghai Mental Health Center
- Diseases
- Depression
- NCT number
- NCT07735143
What you commit to
- Study type: Observational
- Planned participants: 150
- From 1 Sept 2027 to the primary completion date, 31 Dec 2027
- 1 site in 1 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.
Prior treatment
- Substance use disorder within 12 months prior to screening.
- Regular antidepressant treatment within 2 weeks prior to enrollment.
- Electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), vagus nerve stimulation (VNS), or immunosuppressive therapy during the current depressive episode.
- Previous treatment with antidepressants, antipsychotics, or mood stabilizers.
Other illness
- \- Severe or unstable medical conditions, pregnancy or breastfeeding, or other conditions considered unsuitable for study participation.
- Current or lifetime diagnosis of other major psychiatric disorders, including schizophrenia spectrum disorders, schizoaffective disorder, or bipolar disorder.
- Depression secondary to medical or neurological conditions.
- Current or lifetime diagnosis of any psychiatric disorder.
- Significant family history of major psychiatric disorders.
Other
- For all participants:
- For the MDD cohort:
- Current active suicidal plan or recent suicidal behavior considered unsuitable for participation.
- For the HC cohort:
- Significant depressive, anxiety, manic, or psychotic symptoms.
Who the study is looking for
- General criteria:
- Participants aged 14-45 years.
- Participants are able to understand the study procedures and provide written informed consent. For participants younger than 18 years, both the participant and their legal guardian must provide consent.
- Major Depressive Disorder (MDD) cohort:
- Meet DSM-5 criteria for major depressive disorder (single or recurrent episode).
- Have a baseline Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥24 and 17-item Hamilton Depression Rating Scale (HAMD-17) score ≥18.
- Healthy Control (HC) cohort:
- \- Healthy participants without a current or lifetime diagnosis of major psychiatric disorders.
Age in the registry: 14 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Mental Health Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.