Eligibility Details:
Inclusion Criteria:
1. Male and female subjects between the ages of 18 - 65 years of age who speak and read
English.
2. Participants able to provide written informed consent to participate in the study.
3. Participants with a primary diagnosis of a DSM-V depressive disorder, including
subjects with comorbidity of a non-psychotic behavioral disorder.
4. Participants with comorbidity of mild traumatic brain injury (mTBI) are eligible for
inclusion in this study. mTBI will be defined according to best clinical practice
guidelines. The subject should have experienced no more than 30 minutes of loss of
consciousness, less than a 24 hour alteration in consciousness or mental status, less
than 24 hours of post-traumatic amnesia and a Glasgow Coma Scale (best available score
in the first 24 hours) of 13 or greater.
5. Participants with comorbidity of post-traumatic stress disorder (PTSD) are eligible
for inclusion in this study. A score of 45 or greater on the PTSD Checklist
Military/Civilian (PCL-M/C) measurement tool will qualify a subject for inclusion of
diagnosis of PTSD as a comorbid condition.
6. Able to stop specified medications, including drugs of abuse, for 5 half-lives of the
medication(s). See Appendix B for a list of the five half-life time periods for these
medications.
• The potential subject's primary care physician may be consulted to make these
determinations.
7. Able to be washed out of specified medications within 14 days, i.e. 5 half-lives are
not longer than 14 days (See Appendix B).
8. Participants will be selected from patients on the psychiatric inpatient ward,
partially hospitalized patients, and psychiatric outpatients.
9. Ability to comply with the requirements of the study.
Exclusion Criteria:
1. Male and female subject less than 18 years old or greater than 65 years old
2. Participants who cannot provide written informed consent
3. Diagnosis of a psychotic disorder.
4. History of, or current, open head brain trauma.
5. Subjects with comorbidity of mild traumatic brain injury (mTBI) or traumatic brain
injury (TBI) who experienced greater than 30 minutes loss of consciousness, greater
than 24 hour alteration in consciousness or mental status, greater than 24 hours of
post traumatic amnesia, or a Glasgow Coma Scale (best available score in first 24
hours) of less than 13.
6. Subjects who, in the opinion of the investigator, are unable to washout of specified
medications in a period of 14 days or less..
7. History of: craniotomy, cerebral metastases, cerebrovascular accident; current
diagnosis of seizure disorder, schizophrenia, schizo-affective disorder, dementia,
mental retardation, or major depression with psychotic features; or use of depot
neuroleptics in last 12 months.
8. Clinically significant medical illness, including thyroid disorders, which cannot be
remediated with medication, e.g. synthroid.
9. Participation in any other therapeutic drug study within 60 days preceding inclusion.
10. Known pregnancy and/or lactation, or intent to become pregnant during this study.
11. Chronic or acute pain requiring prescription pain medication(s) (narcotic or synthetic
narcotic).
12. Candidates with any metal, shrapnel or other similar objects in the head that could
affect the QEEG.
13. Candidates currently stable and considered to be at Maximum Medical Improvement (MMI)
on current medications.
14. Participant has a positive urine drug screen.
15. Participant has active suicidal intent.