An interventional study of The PEER Report in Depression and Non-psychotic Diagnosis as Co-morbidity, sponsored by MYnd Analytics. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-07-30.
Sponsored by MYnd Analytics · Not applicable, Interventional, and Treatment
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.
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
1,327 studies on the registry are indexed under Disease; 596 are open to participants now.
This study's planned enrollment of 150 is above the median of 80 across 732 interventional studies indexed under Disease.
Browse Disease studies →MYnd Analytics is the lead sponsor of 4 studies on the registry; none are open to participants now.
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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.
Exclusion Criteria:
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.
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.
Also known as: the PEER Interactive Report, the PEER Online Report
Quick Inventory of Depressive Symptomatology - Self Report 16 Item Questionnaire
A proven and accepted survey for measuring symptoms of depression
Time frame: Day 0 through study completion, an average of 3 months.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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'.
Time frame: 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
Time frame: Day 0, Day 15, Day 90
Plan to share: No
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