The Canadian Armed Forces PEER Study (PEERCanada)

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

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.

Study Overview

• Status: Unknown
• Conditions: Depression; Non-psychotic Diagnosis as Co-morbidity
• Intervention / Treatment: Device: The PEER Report

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

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Metzig, BA; Phone Number: 949-420-4403; Email: mmetzig@myndanalytics.com
• Study Contact Backup: Name: George Carpenter, B.A.; Phone Number: 9494204401; Email: gcarpenter@myndanalytics.com

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Z 7K4
      • Recruiting
      • The Royal Mental Health Center
      • Contact: Amelie Vezina, B.H.Sc., B.A Psych; Phone Number: (613) 722-6521; Email: Amelie.Vezina@theroyal.ca
      • Contact: Ashley Baddeley, B.A. (Hons.), M.Sc.; Phone Number: (613) 722-6521; Email: ashley.baddeley@theroyal.ca
      • Sub-Investigator: Jacov Shlik, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; All subjects will undergo same study procedures. Subjects in the Control Arm will receive treatment as usual by the prescribing clinician/investigator. The prescribing clinician/investigator will not receive the PEER Report of probable medication response for a control arm subject.
Experimental: Experimental; All subjects will undergo same study procedures. Subjects in the Experimental Arm will receive treatment as usual by the prescribing clinician/investigator. However, the prescribing clinician/investigator will receive the PEER Report of probable medication response for an experimental arm subject. The report will provide additional data/information regarding probable medication response for an experimental arm subject to the prescriber .	Device: The PEER Report; PEER Interactive references a subject's QEEG to a normative and then symptomatic database. By comparing a given subject's QEEG to a database of QEEGs of subjects who have tried and responded to a specific medication, PEER provides useful information regarding the response of neurophysiologically similar subjects to a wide number of medications - providing clinicians with useful information as to medication outcomes before a medication regime is started. Clinicians have also reported that negative findings (in which neurophysiologically similar subjects reported resistant outcomes for certain medications) can be extremely useful in reducing trial and error. It has also been used to help select the medication that best matches the QEEG brainwave pattern.; Other Names: the PEER Interactive Report; the PEER Online Report

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quick Inventory of Depressive Symptomatology - Self Report 16 Item Questionnaire	A proven and accepted survey for measuring symptoms of depression	Day 0 through study completion, an average of 3 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CHRT-7SR:	The Concise Health Risk Tracking Self Report survey (CHRT-7SR) is a 7 question self-report questionnaire that assesses suicidal risk of subjects in clinical practice.	Day 0 through study completion, an average of 3 months.
PCL-M/C - if applicable:	The PTSD Checklist Military/Civilian is a 17-item self-report measure of the 17 DSM-V symptoms of PTSD. The PCL has a variety of purposes, including: screening individuals for PTSD, diagnosing PTSD, monitoring symptom change during and after treatment. The PCL asks about symptoms in response to "stressful experiences." The Military version is often used with active service members and Veterans. The Civilian version can be helpful when assessing survivors who have symptoms due to multiple events.	Day 0 through study completion, an average of 3 months.
Patient-recorded CGI-I (Clinical Global Impressions-Improvement)	CGI-I is an assessment by the physician as to the improvement in the subject's mental health. This is a 7-point scale with all subjects beginning with a rating of 4. A ratings of 1 - 3 indicate degrees of improvement, with 1 being 'very much improved, and 3 being 'minimally improved'. A rating of 5 - 7 indicates degrees of worsening, with 5 being 'minimally worse' and 7 being 'very much worse'. A rating of 4 indicates no change from baseline.	Day 0 through study completion, an average of 3 months.
Physician-recorded CGI-I (Clinical Global Impressions-Improvement)	CGI-I is an assessment by the physician as to the improvement in the subject's mental health. This is a 7-point scale with all subjects beginning with a rating of 4. A ratings of 1 - 3 indicate degrees of improvement, with 1 being 'very much improved, and 3 being 'minimally improved'. A rating of 5 - 7 indicates degrees of worsening, with 5 being 'minimally worse' and 7 being 'very much worse'. A rating of 4 indicates no change from baseline.	Day 0 through study completion, an average of 3 months.
CGI-S (Clinical Global Impressions - Severity) - Physician	CGI-S is a physician-recorded scale that measures the severity of a subject's mental health. It is a 7-point scale with 1 being 'normal' and 7 being 'extremely mentally ill'.	Day 0 through study completion, an average of 3 months.
HAM-D (Hamilton Rating Scale for Depression):	HAM-D is 17-item interview that will be used as a secondary measure to assess the subject's level of depression	Day 0, Day 15, Day 90

Collaborators and Investigators

• Sponsor: MYnd Analytics
• Collaborators: University of Ottawa; Canadian Forces Health Services Centre Ottawa
• Investigators: Principal Investigator: Verner Knott, PhD, The Royal, University of Ottawa

Publications and helpful links

General Publications

• Itil TM, Shapiro DM, Herrmann WM, Schulz W, Morgan V. HZI systems for EEG parametrization and classification of psychotropic drugs. Pharmakopsychiatr Neuropsychopharmakol. 1979 Jan;12(1):4-19. doi: 10.1055/s-0028-1094590.
• Leuchter AF, Cook IA, Marangell LB, Gilmer WS, Burgoyne KS, Howland RH, Trivedi MH, Zisook S, Jain R, McCracken JT, Fava M, Iosifescu D, Greenwald S. Comparative effectiveness of biomarkers and clinical indicators for predicting outcomes of SSRI treatment in Major Depressive Disorder: results of the BRITE-MD study. Psychiatry Res. 2009 Sep 30;169(2):124-31. doi: 10.1016/j.psychres.2009.06.004. Epub 2009 Aug 27.
• DeBattista C, Kinrys G, Hoffman D, Goldstein C, Zajecka J, Kocsis J, Teicher M, Potkin S, Preda A, Multani G, Brandt L, Schiller M, Iosifescu D, Fava M. The use of referenced-EEG (rEEG) in assisting medication selection for the treatment of depression. J Psychiatr Res. 2011 Jan;45(1):64-75. doi: 10.1016/j.jpsychires.2010.05.009. Epub 2010 Jul 3.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2016
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: machine learning; Electroencephalogram; data base
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: CNS013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes