Actively Recruiting
Deep Phenotyping for Clinical Inferring Response in Treatment Resistant Depression
Led by Max-Planck-Institute of Psychiatry · Updated on 2025-05-09
130
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Deep Phenotyping for Clinical Inferring Response in Treatment Resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participation in the Biobanking initiative at Max Planck Institute of Psychiatry
- Age 18 years or older
- Diagnosis of major depressive disorder confirmed by Mini-Interview
- Treatment resistant depression stage I or II
- Indication for antidepressant pharmacotherapy
- Indication for lithium augmentation
- Ability to provide informed consent
You will not qualify if you...
- Under 18 years of age
- Medical conditions that prevent lithium therapy
- History of hypomanic or manic episodes
- Use of two or more antidepressants simultaneously with lithium, except certain sleep-promoting antidepressants
- Use of other pharmacological augmentation strategies with lithium
- Taking more than 100 mg total of quetiapine immediate- or extended-release
- Current substance use disorder except moderate alcohol or benzodiazepine use linked to current episode, or smoking
- Considered unsuitable by the investigator
- Relevant central nervous system comorbidities such as stroke, tumor, epilepsy, CNS inflammation, traumatic brain injury, or past brain surgery
- Inability to provide informed consent
- Receiving electroconvulsive therapy during current depressive episode
- Receiving repetitive transcranial magnetic stimulation during current depressive episode
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Max Planck Insitute of Psychiatry
Munich, Bavaria, Germany, 80804
Actively Recruiting
Research Team
L
Laura E Fischer, MD
CONTACT
F
Florian Raabe, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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