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 @ 9:13 PM
Ignite Modification Date:
2025-12-24 @ 9:13 PM
NCT ID:
NCT01983904
Eligibility Criteria:
Inclusion Criteria:
* age 20-70
* diagnosis of major depressive (MDD)or bipolar disorder(BP)determined independently by 2 study psychiatrists
* current major depressive episode of \>1 year duration, treatment-resistant (meaning failure to respond to 4 different classes of antidepressants, including augmentation or combination strategies with lithium, atypical antipsychotics, anticonvulsants, antidepressants, evidence-based psychotherapy, CBT, or electroconvulsive treatment despite adequate dosage, duration and compliance)
* minimum score of 20 (out of 52) on the 17 item Hamilton Depression Rating Scale (HDRS)
* resident of Alberta, Canada, covered by Alberta Health
Exclusion Criteria:
* other Axis I psychiatric disorders including schizophrenia, psychosis, active suicidal ideation over previous 6 months
* cerebrovascular risk factors, previous stroke, head injury and neurodegenerative disorders, pregnancy, medical and general contraindications for DBS surgery (e.g. cardiac pacemaker/defibrillator)
* age \>70
* diabetes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT01983904
Study Brief:
Protocol Section:
NCT01983904