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 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT01794559
Eligibility Criteria:
Inclusion Criteria:
* Must speak and read English
* Must be able to provide written informed consent
* A primary diagnosis of a DSM-IV depressive disorder
* Co-morbidities of non-psychotic behavioral disorders, including PTSD and mild Traumatic Brain Injury (mTBI) are eligible to participate.
* Able to stop all medications (wash out) for 5 half-lves of all medication(s) which affect the EEG. Outpatient subjects are eligible if they can be washed out of their medications in 14 days or less.
* Ability to comply with the requirements of the study
Exclusion Criteria:
* Diagnosis of a psychotic disorder
* History of, or current, open head trauma
* Subjects who would not be good candidates to be washed out of their medications, in the opinion of the investigator.
* History of craniotomy, cerebral metastases, cerebrovascular accident, current diagnosis of seizure disorder, bipolar disorder, schizophrenia, schizo-affective disorder, dementia, mental retardation, or major depression with psychotic features, or use of depot neuroleptics in the last 12 months.
* Clinically significant medical illness, including thyroid disorders.
* Participation in any other therapeutic drug study within 60 days preceding inclusion in the study.
* Know pregnancy and/or lactation, or intent to become pregnant during the study.
* Chronic or acute pain requiring prescription medication(s).
* Candidates with any metal, shrapnel or other similar objects in the head that could affect the QEEG
* Candidates that are currently stable and considered to be at maximum medical improvement on current medications.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01794559
Study Brief:
Protocol Section:
NCT01794559