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 @ 2:48 AM
Ignite Modification Date:
2025-12-25 @ 2:48 AM
NCT ID:
NCT02622633
Eligibility Criteria:
Inclusion Criteria:
1. The inclusion in this study requires that patients meet the criteria for recurrent Major Depressive Disorder according to the DSM V (recurrent Major Depressive Disorder without psychotic features), being in a current depressive episode lasting at least two years or have produced at least four episodes of major depression, along with the current episode lasting at least one year. All individuals must be adults, women can not be pregnant and must be submitted to contraceptive therapy
2. Subjects must have failed to respond to at least four different trials with antidepressant at therapeutic doses for a period of at least six weeks, associated with specific psychotherapy during this period and/or use of ECT or VNS. The medication treatment for depression used at the moment of selection should remain unchanged for at least eight weeks after implantation and will not change during the study period. Possible needs therapeutic adjustments during the study will be managed with changes in parameter magnetic stimulation
3. Patients should score at least 20 points on the Hamilton Rating Scale (Hamilton Depression Rating Scale-28 (HDRS))
Exclusion Criteria:
1. Pregnancy
2. Preexisting neurological disease including epilepsy
3. Other psychiatric disorders except for anxiety disorders
4. Less than 24 Mini-Mental or any other cognitive disorder
5. Being with serious suicidal ideation
6. Medical conditions that preclude surgery as judgment of the research team
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02622633
Study Brief:
Protocol Section:
NCT02622633