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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT00296920
Eligibility Criteria:
Inclusion Criteria:
* Age 30-70; men and women (non-pregnant)
* Diagnosis: major depressive episode (unipolar) by DSM-IV derived from the SCID-P.
* Recurrent disease; minimum 4 major depressive episodes .
* Chronic illness with current episode \~ 12 months duration
* Response failure to multiple treatment regimens. Resistance or intolerance to at least four treatments from different categories (SSRI, SNRI, TCA, HCA, MAOI, atypical, Lithium, anticonvulsants, ECT, VNS, CBT/IPT). Documentation of adequate dose and duration of each treatment.
* Hamilton Rating Scale for Depression (HRSD-24) score \>20
* Global Assessment of Function. score \~50
* No neurological disease; no other Axis 1 or Axis II diagnosis; no substance abuse
* Stable on current antidepressant meditation regimen or medication free \~4 weeks
* Able to give informed consent in accordance with institutional policies.
* Able to comply with all testing and follow-up visit requirements defined by the Study Protocol. Pre-menopausal women must agree to use acceptable methods of birth control (radiation risk of PET)
Exclusion Criteria:
* Atypical or psychotic subtypes of major depressive disorder.
* Alcohol or substance dependence within 12 months; abuse within 6 months, excluding nicotine Current suicidal ideations, plan or intent for self-harm; in past 3 years, repeated suicide attempts, resulting in emergency room or inpatient care.
* Major medical illness, cardiac pacemaker/defibrillator, and other implanted stimulator.
* Likely to relocate or move to a location distant from the study site within one year of enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT00296920
Study Brief:
Protocol Section:
NCT00296920