Deep Phenotyping for Clinical Inferring Response in Treatment Resistant Depression
Recruiting · NCT06396312 · Observational (researchers observe without assigning treatment) · Lead sponsor: Max-Planck-Institute of Psychiatry
View the official record on ClinicalTrials.gov →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.
Who can take part
Inclusion criteria
- Obligated Participation in "Biobanking" of Max Planck Institute of psychiatry
- Age: ≥18 years
- DSM-V diagnosis of major depressive disorder (MDD; confirmed by Mini-Interview)
- Treatment resistant depression (TRD): TRD stage I or TRD stage II
- Indication for antidepressant pharmacotherapy
- Indication for lithium augmentation
- Ability to provide informed consent
Exclusion criteria
- Age: \< 18 years
- Medical conditions incompatible with lithium therapy
- History of hypomanic or manic episode
- Two or more antidepressant substances simultaneously to lithium, except the combination with sleep-promoting antidepressants like Mirtazapine, Mianserin, or Trazodone
- An alternative pharmacological augmentation strategy simultaneously to lithium disorder
- Quetiapine immediate- and extended release more than 100 mg in total
- Current substance use disorder except for moderate alcohol or benzodiazepine use bound to the current episode, or smoking
- Patients who are not suitable for the study in the opinion of the investigator
- Patients with a relevant comorbidity of the central nervous system such as focal neurological disease (stroke, tumour), current or past epilepsy, CNS inflammation including autoimmune disease, traumatic brain injury, past brain surgery
- Patients that are not able to provide informed consent
- Electroconvulsive therapy (ECT) in the current depressive episode
- Repetitive transcranial magnetic stimulation (rTMS) in the current depressive episode
Where it is running
1 location listed.
- Max Planck Insitute of Psychiatry - Munich, Bavaria, Germany