Набор скоро начнётся NCT07735143

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

— Наблюдательное Major Depressive Disorder (MDD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Major Depressive Disorder (MDD). Базовые параметры: 14 лет — 45 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

iMORE+ Study: An Enhanced Prospective Observational Cohort Study of Major Depressive Disorder Integrating Longitudinal Clinical Characterization and Multi-Omics Profiling

Обзор

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.

Первичные конечные точки

Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 8 [Срок оценки: Baseline to Week 8]

Вторичные конечные точки (12)

Antidepressant Treatment Response Rate Based on Montgomery-Åsberg Depression Rating Scale (MADRS) at Week 8 [Срок оценки: Baseline to Week 8]
17-item Hamilton Depression Rating Scale (HAMD-17)-Defined Treatment Response at Week 8 [Срок оценки: Baseline to Week 8]
Montgomery-Åsberg Depression Rating Scale (MADRS)-Defined Antidepressant Treatment Remission at Week 8 [Срок оценки: Baseline to Week 8]
17-item Hamilton Depression Rating Scale (HAMD-17)-Defined Antidepressant Treatment Remission at Week 8 [Срок оценки: Baseline to Week 8]
Change in Hamilton Anxiety Rating Scale (HAMA) Score From Baseline to Week 8 [Срок оценки: Baseline to Week 8]
Change in Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) Score From Baseline to Week 8 [Срок оценки: Baseline to Week 8]
Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline to Week 8 [Срок оценки: Baseline to Week 8]
Clinical Global Impression-Improvement (CGI-I) Score at Week 8 [Срок оценки: 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 [Срок оценки: Baseline to Week 8]
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Score From Baseline to Week 8 [Срок оценки: Baseline to Week 8]
Change in Sheehan Disability Scale (SDS) Score From Baseline to Week 8 [Срок оценки: Baseline to Week 8]
Incidence of Depressive Relapse During 1-Year Follow-up [Срок оценки: Baseline to 1 year]

Критерии участия

Критерии включения

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.

Критерии исключения

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: