Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-26 @ 11:10 AM
NCT ID:
NCT06396312
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06396312
Study Brief:
Protocol Section:
NCT06396312