DepressionPEERCanadaNCT03625271
The Canadian Armed Forces PEER Study
A study testing The PEER Report in people with Depression and Non-psychotic Diagnosis as Co-morbidity, run by MYnd Analytics at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Non-psychotic Diagnosis as Co-morbidity
- What is being tested?
- The PEER Report
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jun 2016to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
- 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.
- 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.
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- 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.
Who cannot join
- 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..
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- 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.
- Participation in any other therapeutic drug study within 60 days preceding inclusion.
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Royal Mental Health Center
Ottawa, Ontario, K1Z 7K4
Amelie Vezina, B.H.Sc., B.A Psych, (613) 722-6521, Amelie.Vezina@theroyal.ca
Ashley Baddeley, B.A. (Hons.), M.Sc., (613) 722-6521, ashley.baddeley@theroyal.ca
About this 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
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.
Read the 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
- Being tested
- The PEER Report
- Keywords
- Electroencephalogram, data base, machine learning
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The PEER ReportDevice
Also called the PEER Interactive Report, the PEER Online 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Device: The PEER Report |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick Inventory of Depressive Symptomatology - Self Report 16 Item Questionnaire
A proven and accepted survey for measuring symptoms of depression
Measured: Day 0 through study completion, an average of 3 months.
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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'.
Measured: 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
Measured: Day 0, Day 15, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start16 Jun 2016
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MYnd Analytics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Ottawa, Canadian Forces Health Services Centre Ottawa
- Responsible party
- Sponsor
- Investigators
- Verner Knott, PhD, Principal investigator, The Royal, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625271
- Sponsor's protocol ID
- CNS013
- Acronym
- PEERCanada
- Status last verified
- Jul 2020
- First submitted
- 2 Aug 2018
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 419164Leuchter 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.
PubMed 19712979DeBattista 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.
PubMed 20598710Iosifescu 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.
PubMed 18307587Knott 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.
PubMed 11306251
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03625271
- Acronym / sponsor ID
- PEERCanada / CNS013
- Keywords
- Electroencephalogram, data base, machine learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- MYnd AnalyticsIndustry (pharma, biotech, devices)
- Collaborators
- University of Ottawa, Canadian Forces Health Services Centre Ottawa
- Study start
- 16 Jun 2016 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: The PEER ReportAll 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 . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- 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.
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The PEER ReportAlso: the PEER Interactive Report, the PEER Online ReportPEER 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. | Device | Experimental |
Primary outcome
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
6 secondary outcomes
CHRT-7SR:
Time frame: Day 0 through study completion, an average of 3 months.
PCL-M/C - if applicable:
Time frame: Day 0 through study completion, an average of 3 months.
Patient-recorded CGI-I (Clinical Global Impressions-Improvement)
Time frame: Day 0 through study completion, an average of 3 months.
Physician-recorded CGI-I (Clinical Global Impressions-Improvement)
Time frame: Day 0 through study completion, an average of 3 months.
CGI-S (Clinical Global Impressions - Severity) - Physician
Time frame: Day 0 through study completion, an average of 3 months.
HAM-D (Hamilton Rating Scale for Depression):
Time frame: Day 0, Day 15, Day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Background: PubMed 419164Itil 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.
- Background: PubMed 19712979Leuchter 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.
- Results publication: PubMed 20598710DeBattista 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.
- Results publication: PubMed 18307587Iosifescu 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.
- Results publication: PubMed 11306251Knott 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Verner Knott, PhD principal investigator
The Royal, University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The PEER Report in people with Depression and Non-psychotic Diagnosis as Co-morbidity, run by MYnd Analytics at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Metzig, BA (949-420-4403, mmetzig@myndanalytics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quick Inventory of Depressive Symptomatology - Self Report 16 Item Questionnaire (time frame: Day 0 through study completion, an average of 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03625271, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020; AzTrials last refreshed its copy on 27 Oct 2026.