Major Depressive Disorder (MDD)iMORE+NCT07735143
iMORE+ Study: A Multi-Omics Cohort Study of Major Depressive Disorder
An observational study of Major Depressive Disorder (MDD), run by Shanghai Mental Health Center at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder (MDD)
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2027to 1 Feb 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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 diagnosis of any psychiatric disorder.
- Significant depressive, anxiety, manic, or psychotic symptoms.
- Previous treatment with antidepressants, antipsychotics, or mood stabilizers.
- Significant family history of major psychiatric disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Mental Health Center
Shanghai, 200030
Shen He, Dr., 02134773128, shenhe0204@126.com
He, shenhe@smhc.org.cn
About this study
Official title: 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.
Read more
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)
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 8
Secondary outcomes (14)
Antidepressant Treatment Response Rate Based on Montgomery-Åsberg Depression Rating Scale (MADRS) at Week 8
Treatment response is defined as a ≥50% reduction from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 8. The MADRS score ranges from 0 to 60, with higher scores indicating greater depressive symptom severity (worse outcome). The outcome measure is the percentage of participants achieving treatment response.
Measured: Baseline to Week 8
17-item Hamilton Depression Rating Scale (HAMD-17)-Defined Treatment Response at Week 8
Treatment response is defined as a ≥50% reduction from baseline in 17-item Hamilton Depression Rating Scale (HAMD-17) total score at Week 8. The HAMD-17 total score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity (worse outcome). The outcome measure is the percentage of participants achieving treatment response.
Measured: Baseline to Week 8
Montgomery-Åsberg Depression Rating Scale (MADRS)-Defined Antidepressant Treatment Remission at Week 8
Remission is defined as a total score ≤10 on the Montgomery-Åsberg Depression Rating Scale (MADRS) at Week 8. The MADRS score ranges from 0 to 60, with higher scores indicating greater depressive symptom severity (worse outcome). The outcome measure is the percentage of participants achieving remission.
Measured: Baseline to Week 8
17-item Hamilton Depression Rating Scale (HAMD-17)-Defined Antidepressant Treatment Remission at Week 8
Remission is defined as a total score ≤7 on the 17-item Hamilton Depression Rating Scale (HAMD-17) at Week 8. The HAMD-17 score ranges from 0 to 52, with higher scores indicating greater depressive symptom severity (worse outcome). The outcome measure is the percentage of participants achieving remission.
Measured: Baseline to Week 8
Change in Hamilton Anxiety Rating Scale (HAMA) Score From Baseline to Week 8
The Hamilton Anxiety Rating Scale (HAMA) is a clinician-rated scale assessing anxiety symptom severity. The total score ranges from 0 to 56, with higher scores indicating greater anxiety severity (worse outcome).
Measured: Baseline to Week 8
Change in Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) Score From Baseline to Week 8
The Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) assesses biological rhythm disruption. The total score range from 18 to 72, with higher scores indicating greater circadian rhythm disturbance (worse outcome).
Measured: Baseline to Week 8
Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline to Week 8
The Clinical Global Impression-Severity (CGI-S) scale assesses overall illness severity as rated by the clinician. Scores range from 1 to 7, with higher scores indicating greater illness severity (worse outcome). Change in CGI-S score from baseline to Week 8 will be assessed.
Measured: Baseline to Week 8
Clinical Global Impression-Improvement (CGI-I) Score at Week 8
The Clinical Global Impression-Improvement (CGI-I) scale assesses overall clinical improvement after treatment. Scores range from 1 to 7, with lower scores indicating greater improvement (better outcome).
Measured: Baseline to Week 8
Number of Participants With Suicidal Ideation or Suicidal Behavior Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) From Baseline to Week 8
Number of participants with suicidal ideation or suicidal behavior assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Measured: Baseline to Week 8
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Score From Baseline to Week 8
The Snaith-Hamilton Pleasure Scale (SHAPS) is a self-reported scale assessing anhedonia. The total score ranges from 0 to 14, with higher scores indicating greater anhedonia severity (worse outcome). Change in SHAPS score from baseline to Week 8 will be assessed.
Measured: Baseline to Week 8
Change in Sheehan Disability Scale (SDS) Score From Baseline to Week 8
The Sheehan Disability Scale (SDS) is a self-reported scale assessing functional impairment in work/school, social life, and family life. The total score ranges from 0 to 30, with higher scores indicating greater functional impairment (worse outcome). Change in SDS score from baseline to Week 8 will be assessed.
Measured: Baseline to Week 8
Incidence of Depressive Relapse During 1-Year Follow-up
Depressive relapse during 1-year follow-up will be assessed according to DSM-5 criteria and clinically relevant clinical events. The number and percentage of participants experiencing relapse will be reported.
Measured: Baseline to 1 year
Longitudinal Trajectory of Montgomery-Åsberg Depression Rating Scale (MADRS) Score Over 1-Year Follow-up
The Montgomery-Åsberg Depression Rating Scale (MADRS) assesses depressive symptom severity. Total scores range from 0 to 60, with higher scores indicating greater depressive symptom severity (worse outcome). Longitudinal changes in MADRS scores from baseline will be assessed at predefined assessment time points (Baseline, Week 2, Week 4, Week 8, Month 3, Month 6, and Year 1) to characterize trajectories of depressive symptom change over the 1-year follow-up period.
Measured: Baseline, Week 2, Week 4, Week 8, Month 3, Month 6, and Year 1
Longitudinal Trajectory of Sheehan Disability Scale (SDS) Score Over 1-Year Follow-up
The Sheehan Disability Scale (SDS) assesses functional impairment in work/school, social life, and family life. The total score ranges from 0 to 30, with higher scores indicating greater functional impairment (worse outcome). Changes in SDS scores from baseline will be assessed at Week 8, Month 6, and Year 1 to characterize trajectories of functional recovery over the 1-year follow-up period.
Measured: Baseline, Week 8, Month 6, and Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Sep 2027 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- LinGang Laboratory
- Responsible party
- Sponsor
- Investigators
- Shen He, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735143
- Sponsor's protocol ID
- iMORE PLus-MDD-01
- Acronym
- iMORE+
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iMORE+ Study: An Enhanced Prospective Observational Cohort Study of Major Depressive Disorder Integrating Longitudinal Clinical Characterization and Multi-Omics Profiling
- ClinicalTrials.gov ID
- NCT07735143
- Acronym / sponsor ID
- iMORE+ / iMORE PLus-MDD-01
- Conditions
- Major Depressive Disorder (MDD)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- LinGang Laboratory
- Study start
- 1 Sep 2027 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (8 listed)
- 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.
- 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 participants without a current or lifetime diagnosis of major psychiatric disorders.
Key exclusion criteria (14 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 8
Time frame: 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.
14 secondary outcomes
Antidepressant Treatment Response Rate Based on Montgomery-Åsberg Depression Rating Scale (MADRS) at Week 8
Time frame: Baseline to Week 8
17-item Hamilton Depression Rating Scale (HAMD-17)-Defined Treatment Response at Week 8
Time frame: Baseline to Week 8
Montgomery-Åsberg Depression Rating Scale (MADRS)-Defined Antidepressant Treatment Remission at Week 8
Time frame: Baseline to Week 8
17-item Hamilton Depression Rating Scale (HAMD-17)-Defined Antidepressant Treatment Remission at Week 8
Time frame: Baseline to Week 8
Change in Hamilton Anxiety Rating Scale (HAMA) Score From Baseline to Week 8
Time frame: Baseline to Week 8
Change in Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) Score From Baseline to Week 8
Time frame: Baseline to Week 8
Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline to Week 8
Time frame: Baseline to Week 8
Clinical Global Impression-Improvement (CGI-I) Score at Week 8
Time frame: Baseline to Week 8
Number of Participants With Suicidal Ideation or Suicidal Behavior Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) From Baseline to Week 8
Time frame: Baseline to Week 8
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Score From Baseline to Week 8
Time frame: Baseline to Week 8
Change in Sheehan Disability Scale (SDS) Score From Baseline to Week 8
Time frame: Baseline to Week 8
Incidence of Depressive Relapse During 1-Year Follow-up
Time frame: Baseline to 1 year
Longitudinal Trajectory of Montgomery-Åsberg Depression Rating Scale (MADRS) Score Over 1-Year Follow-up
Time frame: Baseline, Week 2, Week 4, Week 8, Month 3, Month 6, and Year 1
Longitudinal Trajectory of Sheehan Disability Scale (SDS) Score Over 1-Year Follow-up
Time frame: Baseline, Week 8, Month 6, and Year 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shen He principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder (MDD), run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shen He (+86 18817314682, shenhe0204@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 8 (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.