Identifying subtypes of treatment-resistant depression
DECIDE- Deep Phenotyping for Clinical Inferring Response in Treatment Resistant Depression -Study
This study is trying to find different types of treatment-resistant depression by looking at various biological and clinical markers to see how patients respond to lithium treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Max-Planck-Institute of Psychiatry Academic / other |
| Locations | 1 site (Munich, Bavaria) |
| Trial ID | NCT06396312 on ClinicalTrials.gov |
What this trial studies
This project aims to identify clinically relevant subtypes of treatment-resistant depression (TRD) through Clinical Deep Phenotyping (CDP). By collecting multimodal biological and clinical-diagnostic markers, including brain imaging, EEG signals, blood tests, and neuropsychological assessments, the study seeks to develop a bio-clinical signature for TRD. This signature will be identified using multivariate machine learning algorithms to better understand patient responses to lithium treatment. The study builds upon the existing biobanking initiative at the Max Planck Institute of Psychiatry.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of major depressive disorder who have not responded adequately to previous antidepressant treatments.
Not a fit: Patients under 18 years old or those with medical conditions incompatible with lithium therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with treatment-resistant depression.
How similar studies have performed: Other studies have shown promise in using deep phenotyping and machine learning approaches to identify treatment responses in depression, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Munich, Bavaria
- Max Planck Insitute of Psychiatry — Munich, Bavaria, Germany (Recruiting)
Study contacts
- Principal investigator: Peter Falkai, MD — Max-Planck-Institute of Psychiatry
- Study coordinator: Laura E Fischer, MD
- Email: decide@psych.mpg.de
- Phone: 0049-89-30622-1418
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.