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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT05701267
Eligibility Criteria:
MDD patients:
Inclusion Criteria:
Satisfy DSM-5 clinical criteria for MDD (acute and subacute duration)
* Unipolar depression (i.e. no bipolar depression/mania)
* Age: 18-65 (m/f)
* Willing and able to provide informed consent and agree that incidental findings are reported
Exclusion Criteria:
* Concurrent neurological disorder (e.g. epilepsy, stroke, head trauma, etc.)
* Current substance or alcohol abuse
* History of psychosis, bipolar depression, autism spectrum disorder, attention deficit hyperactivity disorder or (mild) intellectual disability
* Contra-indication for MRI (see MRI safety form), includes implants, tattoos non-compatible with brain MRI, pregnancy, claustrophobia) Previous or current treatment with electroconvulsive therapy (ECT), deep-brain stimulation (DBS) or transcranial magnetic stimulation (TMS)
* More than 3 depressive episodes in the past
60 healthy controls
Inclusion Criteria:
* Age: 18-65 (m/f)
* Willing and able to provide informed consent and agree that incidental findings are reported
Exclusion Criteria:
* A neurological disorder (e.g. epilepsy, stroke, head trauma, etc.)
* Current substance or alcohol abuse
* History of psychosis, bipolar depression, autism spectrum disorder, attention deficit and hyperactivity disorder or (mild) intellectual disability
* Contra-indication for MRI (see MRI safety form), includes implants, tattoos non-compatible with brain MRI, pregnancy, claustrophobia)
* Has a current episode of a MDD or ever had an MDD
* Previous or current treatment with electroconvulsive therapy (ECT), deep-brain stimulation (DBS) or transcranial magnetic stimulation (TMS)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05701267
Study Brief:
Protocol Section:
NCT05701267