Clinical trial NCT03625271: The Canadian Armed Forces PEER Study
Official title: A Prospective Study to Evaluate the Utility, Safety, and Efficacy of Using PEER Interactive to Inform the Prescription of Medications to Subjects With a Primary Diagnosis of a Depressive Disorder and Comorbidity of Non-psychotic Behavioral Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Non-psychotic Diagnosis as Co-morbidity
Keywords: Electroencephalogram
data base
machine learning
Lead sponsor: MYnd Analytics
Sponsor class: INDUSTRY
Collaborators: name: University of Ottawa
name: Canadian Forces Health Services Centre Ottawa
First posted: 2018-08-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Blinded participants will be randomized into a control or experimental group and receive a quantitative electroencephalogram (QEEG). Experimental group clinicians will use the PEER Interactive Report in the medication prescription process. Control group clinicians will not receive an Outcome Report. For the experimental group the clinician is expected to incorporate the guidance of the subject's PEER Outcome Report. Study staff will note the basis for all medication decisions in the subject's treatment/study file. Two evaluations are being made in this study. 1. Clinical utility of PEER Interactive where the health outcome of the experimental group will be compared to the outcomes of the control group. 2. Validation of the PEER Interactive outcomes database which is intended to measure post-hoc the health outcomes of participants where the research staff's pharmacotherapy decisions agreed with the output of PEER Interactive.
Primary purpose: TREATMENT

Brief summary: This is a prospective, single-blinded, randomized, multicenter study to evaluate the utility, safety, and efficacy of using PEER Interactive - an EEG-based technology - to inform the prescription of medications to participants with a primary diagnosis of a depressive disorder, with or without comorbidity of non-psychotic behavioral disorders, versus treatment as usual.

Detailed description: This study is observational in nature, in that the participants in the control group will be treated according to treatment as usual and best judgment of the treating clinician. The participants in the experimental group will be treated with adjunctive information provided by the PEER Interactive Report. It is a controlled study in that the schedule of visits, procedures and measurements will be defined by the protocol in order to provide consistent data for both the control and experimental groups.

Participants will be blinded as to presence/use of the PEER Interactive Report and will provide the primary efficacy outcome evaluation. All participants will be randomized into a control or experimental group. All participants will receive a quantitative electroencephalogram (QEEG). For those participants in the experimental group, the research staff will receive an Outcome Report from PEER Interactive. The clinician in the experimental group will use the PEER Interactive Report in the medication prescription process. For the control group, the research staff will not receive an Outcome Report. Outcome Reports for the control group will be sequestered for post-hoc analysis.

The research staff will incorporate the information provided by the Outcome Report from PEER Interactive in their prescription decisions. PEER Interactive provides adjunctive information to assist the treating clinician in the clinical decision process. For the experimental group the research staff is expected to follow the guidance of the subject's PEER Outcome Report as regards to the participant's responsiveness to the on-label medications noted in the Report. Although the study staff is strongly encouraged to use the guidance in the medication decision, prescription of medication is a clinical decision and will be made by the research staff

Eligibility criteria: 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.

Primary outcomes:
measure: Quick Inventory of Depressive Symptomatology - Self Report 16 Item Questionnaire
timeFrame: Day 0 through study completion, an average of 3 months.
Secondary outcomes:
measure: CHRT-7SR:
timeFrame: Day 0 through study completion, an average of 3 months.
measure: PCL-M/C - if applicable:
timeFrame: Day 0 through study completion, an average of 3 months.
measure: Patient-recorded CGI-I (Clinical Global Impressions-Improvement)
timeFrame: Day 0 through study completion, an average of 3 months.
measure: Physician-recorded CGI-I (Clinical Global Impressions-Improvement)
timeFrame: Day 0 through study completion, an average of 3 months.
measure: CGI-S (Clinical Global Impressions - Severity) - Physician
timeFrame: Day 0 through study completion, an average of 3 months.
measure: HAM-D (Hamilton Rating Scale for Depression):
timeFrame: Day 0, Day 15, Day 90
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Royal Mental Health Center
state: Ontario
Study officials:
affiliation: The Royal, University of Ottawa
name: Verner Knott, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Iosifescu DV, Greenwald S, Devlin P, Perlis RH, Denninger JW, Alpert JE, Fava M. Pretreatment frontal EEG and changes in suicidal ideation during SSRI treatment in major depressive disorder. Acta Psychiatr Scand. 2008 Apr;117(4):271-6. doi: 10.1111/j.1600-0447.2008.01156.x. Epub 2008 Feb 26.
citation: Knott V, Mahoney C, Kennedy S, Evans K. EEG power, frequency, asymmetry and coherence in male depression. Psychiatry Res. 2001 Apr 10;106(2):123-40. doi: 10.1016/s0925-4927(00)00080-9.