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:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT03421808
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of unipolar major depressive disorder, in a current major depressive episode, without psychotic features
2. Pretreatment Hamilton score ≥ 20
3. Age between 21 and 70 years
4. Fixed and stable antidepressant medications for 3 weeks prior and during the rTMS trial. Limit on benzodiazapenes to lorazepam (or equivalent) up to 3 mg every day
5. Moderate level of resistance to antidepressant treatment in the current episode, defined as failure of 1-4 adequate medication trials or intolerance to at least 3 trials, and duration of current episode ≤ 3 years
6. No history of schizophrenia, schizoaffective disorder, other \[non mood disorder\] psychosis, depression secondary to a medical condition, mental retardation, substance dependence or abuse within the past year (except nicotine), bipolar disorder, psychotic features in this or previous episodes, amnestic disorder, dementia or MMSE ≤24, delirium, obsessive compulsive disorder, post-traumatic stress disorder, panic disorder
7. No current Vagus Nerve Stimulation
8. No history of failing to respond to an adequate course of ECT in this or any episode, and no ECT within the past 3 months
9. No contraindication to MRI
10. No contraindication to rTMS (history of neurological disorder or seizure (except induced by ECT), increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for \>15 minutes, implanted electronic device, metal in the head, or pregnancy)
11. No history of autoimmune, endocrine, viral, or vascular disorder. No unstable cardiac disease, uncontrolled hypertension, or sleep apnea
12. No active suicidal intent or plan, or history of attempt within the past 12 months
13. Willing to provide informed consent
Exclusion Criteria:
1. To ensure that baseline levels of depression severity are stable at the time of study enrollment, patients will be dropped if they show \> 30% improvement in the HRSD score from the time of initial intake (e.g., screening) to the baseline assessment.
2. Patients must have a recordable alpha frequency.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT03421808
Study Brief:
Protocol Section:
NCT03421808