iMORE+ Study: A Multi-Omics Cohort Study of Major Depressive Disorder

NCT07735143 | Not Yet Recruiting

• 1 other identifier: iMORE PLus-MDD-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder (MDD)

Outcome Measures

Primary Outcomes (1)

• Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 8

  The primary outcome is the change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to Week 8 after antidepressant treatment. The MADRS is a clinician-rated scale assessing depressive symptom severity. The total score ranges from 0 to 60, with higher scores indicating greater depressive symptom severity (worse outcome). Change in MADRS total score from baseline to Week 8 will be assessed as the primary clinical endpoint.

  Baseline to Week 8

Secondary Outcomes (14)

• Antidepressant Treatment Response Rate Based on Montgomery-Åsberg Depression Rating Scale (MADRS) at Week 8

  Baseline to Week 8

• 17-item Hamilton Depression Rating Scale (HAMD-17)-Defined Treatment Response at Week 8

  Baseline to Week 8

• Montgomery-Åsberg Depression Rating Scale (MADRS)-Defined Antidepressant Treatment Remission at Week 8

  Baseline to Week 8

• 17-item Hamilton Depression Rating Scale (HAMD-17)-Defined Antidepressant Treatment Remission at Week 8

  Baseline to Week 8

• Change in Hamilton Anxiety Rating Scale (HAMA) Score From Baseline to Week 8

  Baseline to Week 8

Other Outcomes (5)

• Area Under the Receiver Operating Characteristic Curve (AUROC) of Multi-Omics-Based Models for Discriminating Major Depressive Disorder From Healthy Controls

  Baseline

• Area Under the Receiver Operating Characteristic Curve (AUROC) of Multi-Omics-Based Models for Predicting MADRS-Defined Antidepressant Treatment Response at Week 8

  Baseline to Week 8 (baseline predictors and Week 8 treatment response assessment)

• Area Under the Receiver Operating Characteristic Curve (AUROC) of Multi-Omics-Based Models Integrating Baseline Profiles and Week 4 Molecular Changes for Predicting MADRS-Defined Antidepressant Treatment Response at Week 8

  Baseline to Week 8

Study Arms (2)

Major Depressive Disorder (MDD) Cohort

Participants with major depressive disorder (MDD) aged 14-45 years will be enrolled in this cohort. Participants will undergo standardized clinical assessments, biological sample collection, and longitudinal follow-up during antidepressant treatment. Clinical data and biological samples will be collected at predefined time points for multi-omics profiling, including genomics, transcriptomics (bulk and single-cell), proteomics, metabolomics, immune cell phenotyping, and gut microbiome analyses, among others.

Healthy Control (HC) Cohort

Healthy participants aged 14-45 years will be enrolled as a comparison cohort. Participants will undergo baseline clinical assessments and biological sample collection for comparison with individuals with major depressive disorder.

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study enrolls participants aged 14-45 years from outpatient and inpatient psychiatric settings, comprising two cohorts: participants meeting DSM-5 criteria for major depressive disorder (MDD) and demographically matched healthy controls (HCs) without current or lifetime major psychiatric disorders. MDD participants are recruited during an active depressive episode with baseline Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥24 and 17-item Hamilton Depression Rating Scale (HAMD-17) score ≥18. HC participants are frequency-matched to the MDD cohort by age and sex distribution.

You may qualify if:

• 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 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.

You may not qualify if:

• For all participants:
• 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.
• Substance use disorder within 12 months prior to screening. Depression secondary to medical or neurological conditions. 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.
• Current active suicidal plan or recent suicidal behavior considered unsuitable for participation.
• For the HC cohort:
• Current or lifetime psychiatric disorders. Significant depressive, anxiety, manic, or psychotic symptoms. Previous treatment with antidepressants, antipsychotics, or mood stabilizers. Significant family history of major psychiatric disorders.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• LinGang Laboratory: collaborator

Study Sites (1)

Shanghai Mental Health Center

Shanghai, 200030, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Shen He

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shen He

CONTACT

+86 18817314682; shenhe0204@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): September 1, 2027
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

CN (1)