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:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT02379767
Eligibility Criteria:
Inclusion Criteria (for patients):
* Male or female
* Age 18 - 60 years
* ICD-10 diagnosis of severe unipolar depression (ICD-10: F32.2, F32.3; F33.2, F33.3)
* A score of 23 or greater on the 17-item HAM-D
* Signed informed consent form
* Negative urine pregnancy test in women at the screening visit and at PET/MRI days
* Antidepressant and antipsychotic medication in a steady state for at least 10 days prior to inclusion
* Anesthesiological approval for ECT
* Relatively stable mental state which allows for a potential latency period of 10 days until inclusion as concomitant medication must be in steady-state for a minimum of 10 days prior ECT.
Inclusion criteria (for healthy subjects):
* Male or female
* Age 18 - 60 years
* Somatic health based on history, physical examination, ECG, and laboratory screening
* A maximum of 7 points on the 17-item HAM-D
* Signed informed consent form
* Negative urine pregnancy test in women at the screening visit and at PET/MRI days
Exclusion Criteria:
* Concomitant major internistic or neurological illness
* Clinically relevant abnormalities on a general physical examination and routine laboratory screening
* Current substance abuse, including nicotine
* Current or past history of schizophrenia or schizoaffective disorder
* For participants who participated in an earlier neuroimaging study using ionizing radiation, the total radiation exposure dose of 20 mSv over the last 10 years must not be exceeded, as specified in the legislation on radiation protection (Allg. Strahlenschutzverordnung 2010; www.ris.bka.gv.at).
* Presence of any metallic implant contraindicated for MRI
* Previous treatments with electroconvulsive therapy
* Treatment (\< 1 months before screening) with bright light therapy
* Treatment (\< 1 months before screening) with drugs directly affecting the density and/or activity of monoamine oxidase A, e.g. moclobemid.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
60 Years
Study:
NCT02379767
Study Brief:
Protocol Section:
NCT02379767