The Canadian Armed Forces PEER Study (PEERCanada)

• ClinicalTrials.gov Identifier: NCT03625271
• Recruitment Status: Recruiting
• First Posted: August 10, 2018
• Last Update Posted: July 30, 2020
• Sponsor: MYnd Analytics
• Collaborators: University of Ottawa; Canadian Forces Health Services Centre Ottawa
• Information provided by (Responsible Party): MYnd Analytics

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Depression; Non-psychotic Diagnosis as Co-morbidity	Device: The PEER Report	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: The Subject will be blinded as to study arm assignment and will provide the primary outcome measure.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: June 16, 2016
• Estimated Primary Completion Date: June 1, 2021
• Estimated Study Completion Date: December 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. CHRT-7SR: [ Time Frame: Day 0 through study completion, an average of 3 months. ]
   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.
2. PCL-M/C - if applicable: [ Time Frame: Day 0 through study completion, an average of 3 months. ]
   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.
3. Patient-recorded CGI-I (Clinical Global Impressions-Improvement) [ Time Frame: Day 0 through study completion, an average of 3 months. ]
   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.
4. Physician-recorded CGI-I (Clinical Global Impressions-Improvement) [ Time Frame: Day 0 through study completion, an average of 3 months. ]
   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.
5. CGI-S (Clinical Global Impressions - Severity) - Physician [ Time Frame: Day 0 through study completion, an average of 3 months. ]
   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'.
6. HAM-D (Hamilton Rating Scale for Depression): [ Time Frame: Day 0, Day 15, Day 90 ]
   HAM-D is 17-item interview that will be used as a secondary measure to assess the subject's level of depression

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Michael Metzig, BA; 949-420-4403; mmetzig@myndanalytics.com

Contact: George Carpenter, B.A.; 9494204401; gcarpenter@myndanalytics.com

Locations

Canada, Ontario

The Royal Mental Health Center; Recruiting

Ottawa, Ontario, Canada, K1Z 7K4

Contact: Amelie Vezina, B.H.Sc., B.A Psych (613) 722-6521 Amelie.Vezina@theroyal.ca

Contact: Ashley Baddeley, B.A. (Hons.), M.Sc. (613) 722-6521 ashley.baddeley@theroyal.ca

Sub-Investigator: Jacov Shlik, M.D.

Sponsors and Collaborators

MYnd Analytics

University of Ottawa

Canadian Forces Health Services Centre Ottawa

Investigators

• Principal Investigator: Verner Knott, PhD; The Royal, University of Ottawa

More Information

Publications of Results:

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.

Other 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.

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.

• Responsible Party: MYnd Analytics
• ClinicalTrials.gov Identifier: NCT03625271
• Other Study ID Numbers: CNS013
• First Posted: August 10, 2018
• Last Update Posted: July 30, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by MYnd Analytics:

Electroencephalogram; data base; machine learning

Additional relevant MeSH terms:

Depression; Behavioral Symptoms