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 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT06500533
Eligibility Criteria:
Inclusion Criteria:
* Male or female, between 22 and 80 years of age.
* Able to provide informed consent.
* Primary diagnosis of depressive episode (F32) or recurrent depressive disorder (F33), according to International Classification of Diseases 10th Revision (ICD-10).
* Simultaneous fulfillment of diagnostic criteria for Major Depressive Disorder (MDD) and currently experiencing a Major Depressive Episode (MDE), according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
* Currently experiencing moderate to severe depressive episodes (scores ≥20 on the 17-item Hamilton Depression Rating Scale \[HAM-D 17\]).
Exclusion Criteria:
* Primary psychiatric diagnosis other than single episode depressive disorder or recurrent depressive disorder.
* History of schizophrenia or schizoaffective disorders.
* Any history of psychotic symptoms in the current or previous depressive episodes.
* History of obsessive-compulsive disorder.
* History of autism spectrum disorder.
* History of intractable migraine.
* Clinical conditions that would increase risks associated with receiving high-dose iTBS.
* Cochlear implants.
* Epilepsy.
* Pacemakers.
* Presence of metal in the head, especially of a ferromagnetic type.
* Presence of magnetically controlled implantable devices.
* Current drug misuse (F10-F19).
* History of positive screening urine test for drugs of abuse at screening: cocaine, amphetamines, barbiturates, opiates.
* Current (or chronic) use of opiates.
* Prior nonresponse to rTMS.
* Prior nonresponse to Electroconvulsive Therapy (ECT).
* Female that is pregnant or breastfeeding.
* Female with a positive pregnancy test at participation.
* History of psychosurgery for depression.
* Damage to- or diseases of the skin, which affects the scalp. E.g. Psoriasis or open wounds.
* No changes in psychotropic medication during the study will be allowed, with the exception of the ones due to intolerability.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
80 Years
Study:
NCT06500533
Study Brief:
Protocol Section:
NCT06500533