Deep Phenotyping for Clinical Inferring Response in Treatment Resistant Depression

Recruiting now

Conditions studied: Depressive; Disorder, Major, Single Episode, Major, With Psychotic Symptoms, Depressive; Disorder, Major, Single Episode, Major (Without Psychotic Symptoms), Depressive Disorder, Major, Recurrent, With Psychotic Symptoms, Depressive Disorder, Major, Recurrent, Without Psychotic Symptoms, Depressive Disorder, Treatment-Resistant, Class I or II, Depressive Disorder, Major, Moderate, Depressive Disorder, Major, Severe

In brief

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.

Key facts

Study ID: NCT06396312
Run by: Max-Planck-Institute of Psychiatry
People needed: 130
Starts: 2024-04-02
Expected to finish: 2029-04-01
Last updated by the study team: 2025-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Max Planck Insitute of Psychiatry — Munich, Bavaria, Germany (enrolling)

Full record on ClinicalTrials.gov

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