iMORE+ Study: An Enhanced Prospective Observational Cohort Study of Major Depressive Disorder Integrating Longitudinal Clinical Characterization and Multi-Omics Profiling
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 8
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 ≥
- •Healthy Control (HC) cohort:
- •- Healthy participants without a current or lifetime diagnosis of major psychiatric disorders.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 8
时间窗: 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.
次要结局
- 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)
- Change in Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) Score From Baseline to Week 8(Baseline to Week 8)
- Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline to Week 8(Baseline to Week 8)
- Clinical Global Impression-Improvement (CGI-I) Score at Week 8(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(Baseline to Week 8)
- Change in Snaith-Hamilton Pleasure Scale (SHAPS) Score From Baseline to Week 8(Baseline to Week 8)
- Change in Sheehan Disability Scale (SDS) Score From Baseline to Week 8(Baseline to Week 8)
- Incidence of Depressive Relapse During 1-Year Follow-up(Baseline to 1 year)
- Longitudinal Trajectory of Montgomery-Åsberg Depression Rating Scale (MADRS) Score Over 1-Year Follow-up(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(Baseline, Week 8, Month 6, and Year 1)