The Canadian Armed Forces PEER Study

NCT03625271 | Unknown DMC

• 1 other identifier: CNS013
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Non-psychotic Diagnosis as Co-morbidity

Keywords

Electroencephalogram; data base; machine learning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• CHRT-7SR:

  Day 0 through study completion, an average of 3 months.

• PCL-M/C - if applicable:

  Day 0 through study completion, an average of 3 months.

• Patient-recorded CGI-I (Clinical Global Impressions-Improvement)

  Day 0 through study completion, an average of 3 months.

• Physician-recorded CGI-I (Clinical Global Impressions-Improvement)

  Day 0 through study completion, an average of 3 months.

• CGI-S (Clinical Global Impressions - Severity) - Physician

  Day 0 through study completion, an average of 3 months.

Study Arms (2)

Control

NO INTERVENTION

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

Interventions

The PEER Report DEVICE

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.

Also known as: the PEER Interactive Report, the PEER Online Report

Experimental

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects between the ages of 18 - 65 years of age who speak and read English.
• Participants able to provide written informed consent to participate in the study.
• Participants with a primary diagnosis of a DSM-V depressive disorder, including subjects with comorbidity of a non-psychotic behavioral disorder.
• 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.
• 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).
• Participants will be selected from patients on the psychiatric inpatient ward, partially hospitalized patients, and psychiatric outpatients.
• Ability to comply with the requirements of the study.

You may not qualify if:

• Male and female subject less than 18 years old or greater than 65 years old
• Participants who cannot provide written informed consent
• Diagnosis of a psychotic disorder.
• History of, or current, open head brain trauma.
• 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.
• Subjects who, in the opinion of the investigator, are unable to washout of specified medications in a period of 14 days or less..
• 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.
• Clinically significant medical illness, including thyroid disorders, which cannot be remediated with medication, e.g. synthroid.
• Known pregnancy and/or lactation, or intent to become pregnant during this study.
• Chronic or acute pain requiring prescription pain medication(s) (narcotic or synthetic narcotic).
• Candidates with any metal, shrapnel or other similar objects in the head that could affect the QEEG.
• Candidates currently stable and considered to be at Maximum Medical Improvement (MMI) on current medications.
• Participant has a positive urine drug screen.
• Participant has active suicidal intent.

Sponsors & Collaborators

• MYnd Analytics: lead
• University of Ottawa: collaborator
• Canadian Forces Health Services Centre Ottawa: collaborator

Study Sites (1)

The Royal Mental Health Center

Ottawa, Ontario, K1Z 7K4, Canada

RECRUITING

Related Publications (5)

• 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.

  PMID: 419164 BACKGROUND

• 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.

  PMID: 19712979 BACKGROUND

• 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.

  PMID: 20598710 RESULT

• 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.

  PMID: 18307587 RESULT

• 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.

  PMID: 11306251 RESULT

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Verner Knott, PhD

  The Royal, University of Ottawa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Metzig, BA

CONTACT

949-420-4403; mmetzig@myndanalytics.com

George Carpenter, B.A.

CONTACT

9494204401; gcarpenter@myndanalytics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The Subject will be blinded as to study arm assignment and will provide the primary outcome measure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 10, 2018
• Study Start: June 16, 2016
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 30, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)