iMORE+ Study: A Multi-Omics Cohort Study of Major Depressive Disorder (iMORE+)
30 de julio de 2026 actualizado por: Shanghai Mental Health Center
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Tipo de estudio
De observación
Inscripción (Estimado)
150
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Shen He
- Número de teléfono: +86 18817314682
- Correo electrónico: shenhe0204@126.com
Ubicaciones de estudio
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Shanghai, Porcelana, 200030
- Shanghai Mental Health Center
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Contacto:
- Shen He, Dr.
- Número de teléfono: 02134773128
- Correo electrónico: shenhe0204@126.com
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Contacto:
- He
- Correo electrónico: shenhe@smhc.org.cn
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Investigador principal:
- Shen He, Dr.
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
Inclusion Criteria:
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 Criteria:
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 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 8
Periodo de tiempo: Baseline to Week 8
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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.
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Baseline to Week 8
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Antidepressant Treatment Response Rate Based on Montgomery-Åsberg Depression Rating Scale (MADRS) at Week 8
Periodo de tiempo: Baseline to Week 8
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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.
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Baseline to Week 8
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17-item Hamilton Depression Rating Scale (HAMD-17)-Defined Treatment Response at Week 8
Periodo de tiempo: Baseline to Week 8
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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.
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Baseline to Week 8
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Montgomery-Åsberg Depression Rating Scale (MADRS)-Defined Antidepressant Treatment Remission at Week 8
Periodo de tiempo: Baseline to Week 8
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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.
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Baseline to Week 8
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17-item Hamilton Depression Rating Scale (HAMD-17)-Defined Antidepressant Treatment Remission at Week 8
Periodo de tiempo: Baseline to Week 8
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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.
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Baseline to Week 8
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Change in Hamilton Anxiety Rating Scale (HAMA) Score From Baseline to Week 8
Periodo de tiempo: Baseline to Week 8
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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).
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Baseline to Week 8
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Change in Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) Score From Baseline to Week 8
Periodo de tiempo: Baseline to Week 8
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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).
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Baseline to Week 8
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Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline to Week 8
Periodo de tiempo: Baseline to Week 8
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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.
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Baseline to Week 8
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Clinical Global Impression-Improvement (CGI-I) Score at Week 8
Periodo de tiempo: Baseline to Week 8
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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).
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Baseline to Week 8
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Number of Participants With Suicidal Ideation or Suicidal Behavior Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) From Baseline to Week 8
Periodo de tiempo: Baseline to Week 8
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Number of participants with suicidal ideation or suicidal behavior assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
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Baseline to Week 8
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Change in Snaith-Hamilton Pleasure Scale (SHAPS) Score From Baseline to Week 8
Periodo de tiempo: Baseline to Week 8
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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.
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Baseline to Week 8
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Change in Sheehan Disability Scale (SDS) Score From Baseline to Week 8
Periodo de tiempo: Baseline to Week 8
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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.
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Baseline to Week 8
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Incidence of Depressive Relapse During 1-Year Follow-up
Periodo de tiempo: Baseline to 1 year
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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.
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Baseline to 1 year
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Longitudinal Trajectory of Montgomery-Åsberg Depression Rating Scale (MADRS) Score Over 1-Year Follow-up
Periodo de tiempo: Baseline, Week 2, Week 4, Week 8, Month 3, Month 6, and Year 1
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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.
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Baseline, Week 2, Week 4, Week 8, Month 3, Month 6, and Year 1
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Longitudinal Trajectory of Sheehan Disability Scale (SDS) Score Over 1-Year Follow-up
Periodo de tiempo: Baseline, Week 8, Month 6, and Year 1
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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.
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Baseline, Week 8, Month 6, and Year 1
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Area Under the Receiver Operating Characteristic Curve (AUROC) of Multi-Omics-Based Models for Discriminating Major Depressive Disorder From Healthy Controls
Periodo de tiempo: Baseline
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A multivariable model integrating clinical characteristics and multi-omics data, including immune profiling (CyTOF and cytokine profiling), genomics, epigenomics, bulk transcriptomics, single-cell transcriptomics, proteomics, metabolomics, and microbiome profiling, will be developed to discriminate participants with major depressive disorder from healthy controls.
Model discrimination performance will be primarily assessed by the area under the receiver operating characteristic curve (AUROC).
Sensitivity, specificity, and predictive accuracy will be reported as supportive metrics.
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Baseline
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Area Under the Receiver Operating Characteristic Curve (AUROC) of Multi-Omics-Based Models for Predicting MADRS-Defined Antidepressant Treatment Response at Week 8
Periodo de tiempo: Baseline to Week 8 (baseline predictors and Week 8 treatment response assessment)
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A multivariable model integrating baseline clinical characteristics and multi-omics data, including immune profiling (CyTOF and cytokine profiling), genomics, epigenomics, bulk transcriptomics, single-cell transcriptomics, proteomics, metabolomics, and microbiome profiling, will be developed to predict antidepressant treatment response at Week 8. Treatment response will be defined as a ≥50% reduction from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 8. Model predictive performance will be primarily assessed by the area under the receiver operating characteristic curve (AUROC), with internal validation performed using bootstrap resampling.
Calibration, sensitivity, specificity, and predictive accuracy will be reported as supportive metrics.
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Baseline to Week 8 (baseline predictors and Week 8 treatment response assessment)
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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
Periodo de tiempo: Baseline to Week 8
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A longitudinal multivariable model integrating baseline clinical characteristics, baseline multi-omics profiles, and multi-omics changes from baseline to Week 4 will be developed to predict MADRS-defined antidepressant treatment response at Week 8. Treatment response will be defined as a ≥50% reduction from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 8. Multi-omics data will include immune profiling (CyTOF and cytokine profiling), genomics, epigenomics, bulk transcriptomics, single-cell transcriptomics, proteomics, metabolomics, and microbiome profiling.
Model predictive performance will be primarily assessed by the area under the receiver operating characteristic curve (AUROC), with internal validation performed using bootstrap resampling.
Calibration, sensitivity, specificity, and predictive accuracy will be reported as supportive metrics.
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Baseline to Week 8
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Number of Significantly Altered Multi-Omics Features From Baseline to Week 8 of Antidepressant Treatment
Periodo de tiempo: Baseline to Week 8
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Longitudinal changes in multi-omics profiles from baseline to Week 8 will be analyzed to identify molecular features significantly altered following antidepressant treatment.
Multi-omics analyses will include immune profiling (CyTOF and cytokine profiling), genomics, epigenomics, bulk transcriptomics, single-cell transcriptomics, proteomics, metabolomics, and microbiome profiling.
Statistically significant features will be identified based on predefined statistical thresholds, and the number of significantly altered features will be reported.
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Baseline to Week 8
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Predictive Performance of Multi-Omics-Based Models for Predicting One-Year Sheehan Disability Scale (SDS) Score
Periodo de tiempo: Baseline to Year 1
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A multivariable model integrating baseline clinical characteristics and multi-omics data will be developed to predict the Sheehan Disability Scale (SDS) total score at 1-year follow-up.
The SDS is a self-reported scale assessing functional impairment.
The SDS total score ranges from 0 to 30, with higher scores indicating greater functional impairment (worse outcome).
Model predictive performance will be assessed using predefined regression metrics, including coefficient of determination (R²), root mean square error (RMSE), and mean absolute error (MAE).
Internal validation will be performed using bootstrap resampling.
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Baseline to Year 1
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Shen He, Shanghai Mental Health Center
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2027
Finalización primaria (Estimado)
31 de diciembre de 2027
Finalización del estudio (Estimado)
1 de febrero de 2028
Fechas de registro del estudio
Enviado por primera vez
20 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
26 de julio de 2026
Publicado por primera vez (Actual)
29 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
30 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- iMORE PLus-MDD-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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