RecruitingNCT06396312

Deep Phenotyping for Clinical Inferring Response in Treatment Resistant Depression

DECIDE- Deep Phenotyping for Clinical Inferring Response in Treatment Resistant Depression -Study


Sponsor

Max-Planck-Institute of Psychiatry

Enrollment

130 participants

Start Date

Apr 2, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

DECIDE- Deep phenotyping for clinical inferring response in treatment resistant depression -Study Building upon the "Biobanking" initiative at the Max Planck Institute of Psychiatry, the present project aims to identify clinically relevant subtypes of treatment-resistant depression (TRD) through Clinical Deep Phenotyping (CDP). According to clinical trials, 30-40% of the patients suffering from TRD benefit from lithium treatment. By collecting multimodal biological and clinical-diagnostic markers, such as structural and functional brain imaging via magnetic resonance imaging (MRI), brain signals from electroencephalography, comprehensive blood tests, assessment of perception and cognition through neuropsychological testing, as well as the evaluation of specific depression symptoms and psychological and other comorbidities using standardized questionnaires, a bio-clinical signature will be identified using multivariate machine learning algorithms as an integration method. This signature aims to predict the response to lithium therapy in TRD. Prospectively, such an algorithm could later personalize the treatment decision of 'lithium administration in TRD'. This concept is in line with the Research Domain Criteria (RDoC) of the National Institute of Mental Health (NIH) and aims to offer lithium therapy as a personalized treatment strategy for TRD. Specifically, this means that the likelihood of treatment response can be estimated before administration based on the results of the present study, thus enabling lithium to be offered specifically to those patients who are likely to benefit from it. The study design is non-interventional, meaning the decision for lithium treatment is made for patients according to clinical routine in accordance with the recommendation of the German National Treatment Guideline (NVL) independent of study enrollment. Study participation does not influence treatment decisions for the patients.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study collects detailed biological, brain imaging, and psychological data from people with treatment-resistant depression — depression that hasn't improved with multiple medications — to understand why some people don't respond to treatment and to identify better therapies. **You may be eligible if...** - You have been diagnosed with major depressive disorder that has not responded to at least two different antidepressant treatments - You are between 18 and 65 years old - You are willing to undergo brain scans, blood tests, and psychological assessments - You are not currently in a manic or psychotic episode **You may NOT be eligible if...** - You have bipolar disorder, schizophrenia, or another primary psychotic condition - You have active substance use disorder - You have a pacemaker or metal implants incompatible with MRI scanning - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Max Planck Insitute of Psychiatry

Munich, Bavaria, Germany

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NCT06396312