Janssen Research & Development, LLC has announced a clinical study focusing on sleep electroencephalogram (EEG) patterns in individuals diagnosed with Major Depressive Disorder (MDD). As of today, the study is listed as ‘not yet recruiting,’ indicating its preparatory stage. This development is particularly relevant for professionals in clinical trials, regulatory affairs, and device performance evaluation.
In this article:
- What is the study about?
- Who is eligible?
- Why does this matter for regulatory teams?
- Frequently Asked Questions
- Conclusion and Key Points
- Disclaimer Information
- Read the Original Announcement
What is the study about?
This clinical study aims to investigate specific EEG features associated with sleep patterns in participants diagnosed with Major Depressive Disorder. Depression often disrupts sleep cycles, and EEG provides valuable insights into brain activity during various sleep stages. Manufacturers and researchers are leveraging these insights to improve therapeutic interventions and precision medicine approaches.
The study is sponsored by Janssen Research & Development, LLC, a well-established entity in pharmaceutical and clinical innovations. Their focus on MDD reflects an effort to address unmet needs in mental health care, with emphasis on identifying actionable biomarkers for treatment efficacy and device integration.
Who is eligible?
Although detailed eligibility criteria are not provided in the announcement, studies of this nature typically recruit adults diagnosed with Major Depressive Disorder according to DSM-5 or equivalent criteria. Specific inclusion and exclusion parameters will likely be disclosed once the recruitment process begins.
Potential participants generally undergo thorough screening to ensure their conditions align with the study objectives. For teams involved in device trials or evaluating clinical performance data, understanding recruitment criteria is essential for predicting study applicability and user risk profiles.
Why does this matter for regulatory teams?
This study has implications for clinical teams and regulatory professionals monitoring device integrations with mental health therapies. Sleep EEG data is vital in understanding therapeutic responses and optimizing medical devices for individualized use. By including evidence-backed approaches in MDD treatment, future devices may benefit from enhanced claims about efficacy and safety.
Regulatory bodies often scrutinize clinical data submitted for device approvals, particularly for mental health applications. Stakeholders in quality management and regulatory affairs should monitor data integrity and compliance as this study progresses toward potential outcomes that could reshape device design criteria.
Frequently Asked Questions
- What is EEG?
Electroencephalogram (EEG) is a method to measure electrical activity in the brain, often used in sleep studies to analyze brainwave patterns. - Why focus on sleep in individuals with MDD?
Sleep disturbances are a hallmark symptom of depressive disorders. Studying sleep patterns can reveal biomarkers and improve therapeutic interventions. - Who sponsors the study?
This study is sponsored by Janssen Research & Development, LLC, which specializes in clinical innovations.
Conclusion and Key Points
This clinical study represents a critical step in linking sleep EEG data with treatment outcomes for Major Depressive Disorder. For regulatory teams, staying informed on emerging biomarkers and device applications in mental health is essential. Future advancements may influence device design standards and therapeutic strategies.
Disclaimer Information
This article is intended for informational purposes only. It is not legal, clinical, or regulatory guidance. Stakeholders should consult appropriate experts for specific advice.
Read the Original Announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07258485?term=medical+device