NCT07735143Toborzás még nem indult
iMORE+ Study: A Multi-Omics Cohort Study of Major Depressive Disorder
iMORE+ Study: An Enhanced Prospective Observational Cohort Study of Major Depressive Disorder Integrating Longitudinal Clinical Characterization and Multi-Omics Profiling
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 3.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 150 (tervezett)
- Első benyújtás
- 2026. júl. 20.
- Kezdés
- 2027. szept. 1.
- Elsődleges befejezés
- 2027. dec. 31.
- Fő szponzor
- Shanghai Mental Health Center
- Betegségek
- Depresszió
- NCT-szám
- NCT07735143
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 150
- 2027. szept. 1. és az elsődleges befejezés (2027. dec. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Substance use disorder within 12 months prior to screening.
- 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.
- Previous treatment with antidepressants, antipsychotics, or mood stabilizers.
Más betegség
- 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.
- Depression secondary to medical or neurological conditions.
- Current or lifetime diagnosis of any psychiatric disorder.
- Significant family history of major psychiatric disorders.
Egyéb
- For all participants:
- Current active suicidal plan or recent suicidal behavior considered unsuitable for participation.
- For the HC cohort:
- Significant depressive, anxiety, manic, or psychotic symptoms.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 14 év – 45 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Shanghai Mental Health Center | Shanghai | Kína | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.