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:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT05630469
Eligibility Criteria:
Inclusion Criteria:
* male or female inpatients (18-65 years old)
* ICD-10 diagnosis of severe unipolar depression (F32.2, F32.3, F33.2, F33.3)
* HAMD17 ≥ 23
* physical health
* ability to understand and willingness to sign the written informed consent document
* negative drug screening, negative urine pregnancy test in women
* antidepressant and antipsychotic medication in steady state for at least 10 days prior inclusion
* anesthesiological approval for ECT
Excusion criteria:
* severe somatic or neurological disease
* current comorbid psychiatric disorder, including bipolar depression (according to DSM-5)
* current or past history of schizophrenia or schizoaffective disorder
* current use of alcohol, drugs of abuse, or any medication in a manner which is indicative of chronic abuse or who meet DSM-5 criteria for alcohol or other substance dependence
* clinically relevant abnormalities on a general physical examination and routine laboratory screening
* pregnancy, breast feeding
* contraindications to lumbar puncture (increased intracranial volume, anticoagulant medication, uncorrected bleeding diathesis, coagulopathy, congenital spine abnormality, recent spinal trauma/surgery, skin infection at puncture site)
* any implant or stainless steel graft contraindicated for MRI
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05630469
Study Brief:
Protocol Section:
NCT05630469