Breaking Down Depression Care for Adolescents: A new research initiative aims to revolutionize patient profiling in adolescent inpatient depression. Sponsored by Jiangsu Province Nanjing Brain Hospital, this observational study introduces advanced multimodal phenotyping to enhance understanding of major depressive disorder (MDD) and bipolar disorder (BD).
Scheduled to take place with ongoing recruitment, the study could provide significant insights for clinical, regulatory, and quality teams monitoring progress in mental health research. It focuses on integrating data-driven approaches, emphasizing the importance of precision medicine in psychiatry.
In this article:
- What are the study details?
- Who is being studied?
- What is the clinical aim?
- FAQs
- What are the implications?
- Professional disclaimer
- Source & access
What are the study details?
According to the ClinicalTrials.gov record provided, this observational study integrates precision medicine principles into psychiatry by employing multimodal phenotyping. This technique involves gathering diverse data points from adolescents diagnosed with MDD and BD. The duration spans data collection and follow-ups, ensuring researchers build deeper profiles for interpreting these conditions.
Research methods combine clinical assessments, biological samples, and psychological evaluations, with the overall goal of understanding mood disorders. As stated by the study sponsor, Jiangsu Province Nanjing Brain Hospital, this endeavor reflects a commitment to advancing personalized treatment in mental healthcare.
Who is being studied?
The patient population targeted includes adolescents diagnosed with either major depressive disorder or bipolar disorder. By focusing on young individuals receiving inpatient care, the study addresses a critical demographic often overlooked in clinical research. Early data integration tools could not only capture symptoms but also map underlying contributors, such as neurological patterns and environmental stressors.
The recruitment criteria emphasize inclusivity and diversity, leveraging longitudinal follow-ups to ensure robust data representation. Stakeholders, including healthcare regulators and policymakers, will find this initiative relevant as it intersects clinical practice and system improvement.
What is the clinical aim?
This research aims to enrich clinical understanding by characterizing adolescent mental health profiles more comprehensively. Multimodal input facilitates accurate phenotypes, creating tailored intervention possibilities. For clinicians, this data represents better precision-oriented screening tools.
Efficiently categorizing adolescents based on phenotypes serves broader regulatory standards too—aligning with the safety and performance expectations described in MDR Annex XIV. By enabling targeted care development, future treatments can potentially align with the real-world needs reflected in this study’s findings.
FAQs
1. What conditions are targeted by the study?
The study focuses on adolescents diagnosed with major depressive disorder (MDD) and bipolar disorder (BD).
2. Who is sponsoring the study?
The research is sponsored by Jiangsu Province Nanjing Brain Hospital.
3. What interventions does the study involve?
Data collection and longitudinal follow-ups are the primary interventions.
4. Can this method support medical device advancements?
Multimodal phenotyping may provide valuable data points for future diagnostics and monitoring tools, though not explicitly stated.
What are the implications?
This study underscores the importance of advanced phenotyping to better understand mood disorders in adolescents. By targeting inpatient care settings, researchers address an integral part of mental healthcare while aligning data usage with regulatory expectations.
For regulatory, clinical, and quality teams, this research’s data-driven focus highlights a shift toward personalized medicine—a growing trend in psychiatry. Understanding its application could influence device development impacting monitoring or diagnostics.
Professional disclaimer
This article is for informational purposes only and should not be considered medical, legal, or professional regulatory advice. Always consult relevant guidelines or legal experts when evaluating compliance or clinical applications.
Source & access
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07247344?term=medical+device