Following people with major depressive disorder to find biological markers
Studies blood and other samples of people with major depressive disorder and healthy volunteers.
Plain-language title generated from the registry record
Registry title: iMORE+ Study: A Multi-Omics Cohort Study of Major Depressive Disorder
Key facts
- Where
- Shanghai, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 14 and 45 years old?
Source: NCT07735143, who can take part
Where in China
- Shanghai Mental Health CenterShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Mental Health Center
- Trial code
- NCT07735143
- Record updated
- 3 August 2026
- Original description
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.Read full original descriptionShow less
iMORE+ Study: An Enhanced Prospective Observational Cohort Study of Major Depressive Disorder Integrating Longitudinal Clinical Characterization and Multi-Omics Profiling
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.
Inclusion: 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.
Exclusion: 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; Severe or unstable medical conditions, pregnancy or breastfeeding, or other conditions considered unsuitable for study participation; For the MDD cohort:; 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; For all participants:; Current active suicidal plan or recent suicidal behavior considered unsuitable for participation; For the HC cohort:; Significant depressive, anxiety, manic, or psychotic symptoms.