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 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT04783103
Eligibility Criteria:
Inclusion Criteria:
* • In- and outpatients (age 65 year or older).
* Meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM 5) criteria for unipolar depression according 17-item Hamilton depression rating scale (HDRS-17) score of 17 or more.
* Failed to respond to at least one adequate course with an antidepressant medication trial, including the current one.
* Intention to continue the current (\>6 weeks) antidepressant treatment at a stable dose dur-ing the stimulation.
* Benzodiazepines are permitted up to a maximum dose of 40 mg diazepam or equivalent. If the dosage has been recently changed, it should be stable for at least 2 weeks.
* Able to read, understand and sign the Informed Consent Form.
Exclusion Criteria:
* • Psychosis (except depression with psychotic features).
* A personal history of seizures or epilepsy, a history of seizures or epilepsy in first degree relatives and the presence of any known factor that can lower the seizure threshold (sleep deprivation, substance abuse, etc.), previous head injury and the presence of metallic implants in the cephalic region (e.g., aneurysm clips, shunts, stimulators, cochlear implants, electrodes) with the exception of dental fillings. The presence of cardiac pacemakers, neurostimulators, surgical clips or other electronic equipment, comorbidity with the following neurological disorders: increased intracranial pressure, space-occupying lesion, history of stroke or transient ischemic attack, brain aneurysm and any structural brain damage with increased risk for epilepsy detected with (study related) MRI.
* Patients with cognitive disturbances or dementia (Mini Mental State) \< 24.
* Suicide attempt within 6 months before the start of the study or present high risk of suicide per the investigator's clinical judgment and indicative response\* on the Columbia-Suicide Severity Rating Scale (C-SSRS) and 21-items Beck Scale for Suicide Ideation (BSI). \*'yes' on Item 5 (active suicidal ideation with specific plan and intent).
* Any change in the habitual psychopharmacological agents will be considered as dropout.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT04783103
Study Brief:
Protocol Section:
NCT04783103