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 @ 1:49 PM
Ignite Modification Date:
2025-12-24 @ 1:49 PM
NCT ID:
NCT05516095
Eligibility Criteria:
Inclusion Criteria:
* A MADRS score of =/ \> 20 (moderate depression).
* The current depressive episode must have lasted more than 2 weeks but less than 2 years
* Drug therapy must have been stable for the last three weeks prior to the first treatment day with iTBS and is to be kept stable throughout the study until 4 weeks after the last day of iTBS treatment.
* Patients must volunteer to provide informed consent, be able to follow the treatment schedule and have a satisfactory safety screening for iTBS and MRI.
Exclusion Criteria:
* The current depressive episode is in the mild range or contrary that the current episode fulfills the criteria for a major depressive episode requiring inpatient treatment and/or electroconvulsive therapy.
* The current depressive episode is clearly triggered by grief or a recent major stressful life event.
* Bipolar disorder.
* Borderline personality disorder.
* Psychotic symptoms the last 6 months.
* Alcohol or substance abuse/addiction in the last 6 months.
* Current eating disorders.
* Obsessive- compulsive disorders.
* Post-traumatic stress disorder.
* Any medical history of seizure.
* Any neurological or neurosurgical pathologies.
* Any current cardiac or systemic disease.
* Metallic prosthetic material or foreign objects in the body (pacemakers, internal cardioverter defibrillator units, insulin pump, prosthetic eye equipment, etc.).
* Previously diagnosed developmental disorder.
* Pregnancy or lactating.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
65 Years
Study:
NCT05516095
Study Brief:
Protocol Section:
NCT05516095