<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02988076</url>
  </required_header>
  <id_info>
    <org_study_id>CNSR012</org_study_id>
    <nct_id>NCT02988076</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Safety and Efficacy of PEER Interactive to Inform Medication Prescription for Subjects With a Primary Diagnosis of Depression</brief_title>
  <acronym>SMART-MD</acronym>
  <official_title>A Prospective, Double Blind, Randomized, Controlled, Multisite Study to Evaluate the Utility, Safety, and Efficacy of Using PEER Interactive to Inform Medication Prescription to Subjects With a Primary Diagnosis of a Depressive Disorder(SMART-MD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MYnd Analytics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mount Sinai Hospital, New York</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>MYnd Analytics</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multicenter, randomized, double-blind, controlled study to evaluate&#xD;
      the effectiveness of Psychiatric Electroencephalogram Registry (PEER) Interactive to inform&#xD;
      medication prescription in subjects with a primary diagnosis of depression with comorbidity&#xD;
      of non-psychotic behavioral disorders versus treatment as usual, as determined by the&#xD;
      investigator. The primary measurement for improvement of the subjects depression will be a&#xD;
      self-evaluation questionnaire, the Quick Inventory of Depressive Symptomatology-Self Report&#xD;
      16 , but the investigators will also collect information on their clinical global improvement&#xD;
      and any reduction in adverse events.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is prospective in nature. Subjects in the control group will be treated according&#xD;
      to treatment as usual and best judgment of the treating physician. For the experimental group&#xD;
      the treating physician will follow the guidance of the subject's PEER Interactive Report as&#xD;
      regards sensitivity to on-label medications and classes of medication.&#xD;
&#xD;
      The subjects will be washed out of all current medications prior to having an&#xD;
      electroencephalogram (EEG), which is necessary to generate the PEER Interactive Report. The&#xD;
      wash out period for outpatients is no longer than 14 days.&#xD;
&#xD;
      The subjects will be followed for 3 months after the initial treatment. The patient will be&#xD;
      seen on a routine basis and assessments will be made at each interaction to evaluate the&#xD;
      patient's improvement in mental health. The subjects will also be closely evaluated to&#xD;
      determine if they are experiencing any psychiatric specific adverse events. The investigator&#xD;
      is allowed to treat the patient according to their best medical judgment, which may include&#xD;
      adding or changing medications, seeing the patient more frequently, or other interventions&#xD;
      such as the use of sleep aids.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Lack of recruiting at primary study site&#xD;
  </why_stopped>
  <start_date>November 2016</start_date>
  <primary_completion_date type="Actual">December 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The subject is masked as to assignment to Control or Treatment Group. The subject acts as the blinded rater - providing the primary outcome measure - the Quick Inventory of Depressive Symptomatology - 16 Item Self report</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Quick Inventory of Depressive Symptomatology - Self Report 16 questionnaire (QIDS-SR16)</measure>
    <time_frame>4 months</time_frame>
    <description>A self reported survey - blinded subject acts as blinded rater/outcomes assessor. We will use this survey to measure the subject's self-reported change in symptoms of depression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impressions - Improvement (CGI-I)</measure>
    <time_frame>4 months</time_frame>
    <description>Commonly used measure of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impressions - Severity (CGI-S)</measure>
    <time_frame>4 months</time_frame>
    <description>Commonly used measure of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concise Health Risk Tracking Scale - 7 item Self Report Survey (CHRT- SR7)</measure>
    <time_frame>4 months</time_frame>
    <description>A 7 question self-report questionnaire that assesses suicidal risk of subjects in clinical practice</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">468</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The Control group subjects will undergo all procedures e.g. medication washout and baseline electroencephalogram, administered to the Treatment/Experimental group. A clinician treating a Control Group subject will NOT receive the Psychiatric Electroencephalogram Evaluation Registry (PEER) Interactive Report (of probable medication response) under investigation and will treat the Subject with Standard of Care. The subject will be blinded to group assignment and will provide the primary outcome measure - Quick Inventory of Depressive Symptomatology - Self Report 16 item questionnaire.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention - Psychiatric Electroencephalogram Evaluation Registry (PEER) Interactive Report - Treatment group subjects will undergo all procedures e.g. medication washout and baseline electroencephalogram, administered to the Control group. A clinician treating a Treatment Group subject will receive the Psychiatric Electroencephalogram Evaluation Registry (PEER) Report (of probable medication response) under investigation and will incorporate the Report information during prescription of medications to the Subject. The subject will be blinded to group assignment and will provide the primary outcome measure - Quick Inventory of Depressive Symptomatology - Self Report 16 item questionnaire.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PEER Interactive Report</intervention_name>
    <description>A subinvestigator treating a Treatment Group subject will receive the Psychiatric Electroencephalogram Evaluation Registry (PEER) Interactive Report (of probable medication response) under investigation and will incorporate the Report information during prescription of medications to the Subject. A subinvestigator treating a Control Group subject will NOT receive the PEER Report and will treat the Subject with Standard of Care. The subject will be blinded to group assignment and will provide the primary outcome measure - Quick Inventory of Depressive Symptomatology - Self Report 16 item questionnaire.</description>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>PEER Report</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female subjects between the ages of 18 - 65 years of age or older who speak&#xD;
             and read English.&#xD;
&#xD;
          2. Subjects able to provide written informed consent to participate in the study.&#xD;
&#xD;
          3. Subjects with a primary diagnosis of a Diagnostic and Statistical Manual of Mental&#xD;
             Disorders (DSM-V) depressive disorder. Please see Appendix D for definitions.&#xD;
&#xD;
          4. Subjects with comorbidity of a non-psychotic behavioral disorder. Please see Appendix&#xD;
             D for definitions.&#xD;
&#xD;
          5. Subjects with comorbidity of mild traumatic brain injury (mTBI) are eligible for&#xD;
             inclusion in this study.&#xD;
&#xD;
          6. Subjects with comorbidity of post-traumatic stress disorder (PTSD) are eligible for&#xD;
             inclusion in this study. A score of 45 or greater on the PTSD Checklist Civilian&#xD;
             (PCL-C) measurement tool will qualify a subject for inclusion of diagnosis of PTSD as&#xD;
             a comorbid condition.&#xD;
&#xD;
          7. Able to stop specified medications, including drugs of abuse, for 5 half-lives of the&#xD;
             medication(s). See Appendix E for a list of the withdrawal periods for medications.&#xD;
             The potential subject's primary care physician may be consulted to make these&#xD;
             determinations.&#xD;
&#xD;
          8. Able to be washed out of medications within 14 days, i.e. 5 half-lives are not longer&#xD;
             than 14 days (See Appendix E).&#xD;
&#xD;
          9. Ability to comply with the requirements of the study.&#xD;
&#xD;
             -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Male and female subjects less than 18 years old or greater than 65 years old.&#xD;
&#xD;
          2. Subjects who cannot provide written informed consent.&#xD;
&#xD;
          3. Diagnosis of a psychotic disorder. Please see Appendix D for definitions.&#xD;
&#xD;
          4. History of, or current, open head brain trauma.&#xD;
&#xD;
          5. Subjects with comorbidity of traumatic brain injury (TBI) who experienced greater than&#xD;
             30 minutes loss of consciousness, greater than 24 hour alteration in consciousness or&#xD;
             mental status, greater than 24 hours of post traumatic amnesia, or a Glasgow Coma&#xD;
             Scale (best available score in first 24 hours) of less than 13.&#xD;
&#xD;
          6. Subjects who, in the opinion of the investigator would not be good candidates to be&#xD;
             washed out of specified medications (Appendix E) and are unable to washout medications&#xD;
             and/or supplements in a period of 14 days or less.&#xD;
&#xD;
          7. History of: craniotomy, cerebral metastases, cerebrovascular accident; current&#xD;
             diagnosis of seizure disorder, schizophrenia, schizo-affective disorder, dementia,&#xD;
             mental retardation, or major depression with psychotic features; or use of depot&#xD;
             neuroleptics in last 12 months.&#xD;
&#xD;
          8. Clinically significant medical illness, including thyroid disorders, diabetes, etc.,&#xD;
             which cannot be remediated with medication, e.g. synthroid, insulin, etc.&#xD;
&#xD;
          9. Participation in any other therapeutic drug study within 60 days preceding inclusion.&#xD;
&#xD;
         10. Known pregnancy and/or lactation, or intent to become pregnant during this study.&#xD;
&#xD;
         11. Chronic or acute pain requiring prescription pain medication(s) (narcotic or synthetic&#xD;
             narcotic).&#xD;
&#xD;
         12. Candidates with any metal, shrapnel or other similar objects in the head that could&#xD;
             affect the QEEG.&#xD;
&#xD;
         13. Candidates currently stable on current medications.&#xD;
&#xD;
         14. Pre-entry subject whose urine drug screen is positive for drugs of abuse.&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Iosifescu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mount Sinai Hospital, New York, N.Y.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Carolina Partners</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>20598710</PMID>
  </reference>
  <reference>
    <citation>Demyttenaere K, Desaiah D, Petit C, Croenlein J, Brecht S. Patient-assessed versus physician-assessed disease severity and outcome in patients with nonspecific pain associated with major depressive disorder. Prim Care Companion J Clin Psychiatry. 2009;11(1):8-15. doi: 10.4088/pcc.08m00670.</citation>
    <PMID>19333404</PMID>
  </reference>
  <reference>
    <citation>Duffy FH, Burchfiel JL, Lombroso CT. Brain electrical activity mapping (BEAM): a method for extending the clinical utility of EEG and evoked potential data. Ann Neurol. 1979 Apr;5(4):309-21. doi: 10.1002/ana.410050402.</citation>
    <PMID>443765</PMID>
  </reference>
  <reference>
    <citation>Hughes JR, John ER. Conventional and quantitative electroencephalography in psychiatry. J Neuropsychiatry Clin Neurosci. 1999 Spring;11(2):190-208. doi: 10.1176/jnp.11.2.190.</citation>
    <PMID>10333991</PMID>
  </reference>
  <reference>
    <citation>Hoffman DA, Debattista C, Valuck RJ, Iosifescu DV. Measuring severe adverse events and medication selection using a &quot;PEER Report&quot; for nonpsychotic patients: a retrospective chart review. Neuropsychiatr Dis Treat. 2012;8:277-84. doi: 10.2147/NDT.S31665. Epub 2012 Jun 21.</citation>
    <PMID>22802691</PMID>
  </reference>
  <reference>
    <citation>Rush AJ, Bernstein IH, Trivedi MH, Carmody TJ, Wisniewski S, Mundt JC, Shores-Wilson K, Biggs MM, Woo A, Nierenberg AA, Fava M. An evaluation of the quick inventory of depressive symptomatology and the hamilton rating scale for depression: a sequenced treatment alternatives to relieve depression trial report. Biol Psychiatry. 2006 Mar 15;59(6):493-501. doi: 10.1016/j.biopsych.2005.08.022. Epub 2005 Sep 30.</citation>
    <PMID>16199008</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>database</keyword>
  <keyword>probability</keyword>
  <keyword>response</keyword>
  <keyword>depression</keyword>
  <keyword>medication</keyword>
  <keyword>quantitative</keyword>
  <keyword>electroencephalogram</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>CNSR012 Protocol</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>http://myndanalytics.com</doc_url>
      <doc_comment>Please email snavarre@myndanalytics.com for approved version of the protocol</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>CNSR012 ICD</doc_id>
      <doc_type>Informed Consent Form</doc_type>
      <doc_url>http://myndanalytics.com</doc_url>
      <doc_comment>Please email snavarre@myndanalytics.com for approved version of ICD</doc_comment>
    </study_doc>
  </study_docs>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02988076
org study id: CNSR012
nct id: NCT02988076
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a prospective, multicenter, randomized, double-blind, controlled study to evaluate
      the effectiveness of Psychiatric Electroencephalogram Registry (PEER) Interactive to inform
      medication prescription in subjects with a primary diagnosis of depression with comorbidity
      of non-psychotic behavioral disorders versus treatment as usual, as determined by the
      investigator. The primary measurement for improvement of the subjects depression will be a
      self-evaluation questionnaire, the Quick Inventory of Depressive Symptomatology-Self Report
      16 , but the investigators will also collect information on their clinical global improvement
      and any reduction in adverse events.
This study is prospective in nature. Subjects in the control group will be treated according
      to treatment as usual and best judgment of the treating physician. For the experimental group
      the treating physician will follow the guidance of the subject's PEER Interactive Report as
      regards sensitivity to on-label medications and classes of medication.

      The subjects will be washed out of all current medications prior to having an
      electroencephalogram (EEG), which is necessary to generate the PEER Interactive Report. The
      wash out period for outpatients is no longer than 14 days.

      The subjects will be followed for 3 months after the initial treatment. The patient will be
      seen on a routine basis and assessments will be made at each interaction to evaluate the
      patient's improvement in mental health. The subjects will also be closely evaluated to
      determine if they are experiencing any psychiatric specific adverse events. The investigator
      is allowed to treat the patient according to their best medical judgment, which may include
      adding or changing medications, seeing the patient more frequently, or other interventions
      such as the use of sleep aids.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: The subject is masked as to assignment to Control or Treatment Group. The subject acts as the blinded rater - providing the primary outcome measure - the Quick Inventory of Depressive Symptomatology - 16 Item Self report
measure: Quick Inventory of Depressive Symptomatology - Self Report 16 questionnaire (QIDS-SR16)
time frame: 4 months
description: A self reported survey - blinded subject acts as blinded rater/outcomes assessor. We will use this survey to measure the subject's self-reported change in symptoms of depression.
measure: Clinical Global Impressions - Improvement (CGI-I)
time frame: 4 months
description: Commonly used measure of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders
measure: Clinical Global Impressions - Severity (CGI-S)
time frame: 4 months
description: Commonly used measure of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders.
measure: Concise Health Risk Tracking Scale - 7 item Self Report Survey (CHRT- SR7)
time frame: 4 months
description: A 7 question self-report questionnaire that assesses suicidal risk of subjects in clinical practice
arm group label: Control
arm group type: No Intervention
description: The Control group subjects will undergo all procedures e.g. medication washout and baseline electroencephalogram, administered to the Treatment/Experimental group. A clinician treating a Control Group subject will NOT receive the Psychiatric Electroencephalogram Evaluation Registry (PEER) Interactive Report (of probable medication response) under investigation and will treat the Subject with Standard of Care. The subject will be blinded to group assignment and will provide the primary outcome measure - Quick Inventory of Depressive Symptomatology - Self Report 16 item questionnaire.
arm group label: Treatment
arm group type: Active Comparator
description: Intervention - Psychiatric Electroencephalogram Evaluation Registry (PEER) Interactive Report - Treatment group subjects will undergo all procedures e.g. medication washout and baseline electroencephalogram, administered to the Control group. A clinician treating a Treatment Group subject will receive the Psychiatric Electroencephalogram Evaluation Registry (PEER) Report (of probable medication response) under investigation and will incorporate the Report information during prescription of medications to the Subject. The subject will be blinded to group assignment and will provide the primary outcome measure - Quick Inventory of Depressive Symptomatology - Self Report 16 item questionnaire.
intervention type: Device
intervention name: PEER Interactive Report
description: A subinvestigator treating a Treatment Group subject will receive the Psychiatric Electroencephalogram Evaluation Registry (PEER) Interactive Report (of probable medication response) under investigation and will incorporate the Report information during prescription of medications to the Subject. A subinvestigator treating a Control Group subject will NOT receive the PEER Report and will treat the Subject with Standard of Care. The subject will be blinded to group assignment and will provide the primary outcome measure - Quick Inventory of Depressive Symptomatology - Self Report 16 item questionnaire.
arm group label: Treatment
other name: PEER Report
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Daniel Iosifescu, PhD
role: Principal Investigator
affiliation: Mount Sinai Hospital, New York, N.Y.
facility: 
country: United States
citation: 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
citation: Demyttenaere K, Desaiah D, Petit C, Croenlein J, Brecht S. Patient-assessed versus physician-assessed disease severity and outcome in patients with nonspecific pain associated with major depressive disorder. Prim Care Companion J Clin Psychiatry. 2009;11(1):8-15. doi: 10.4088/pcc.08m00670.
PMID: 19333404
citation: Duffy FH, Burchfiel JL, Lombroso CT. Brain electrical activity mapping (BEAM): a method for extending the clinical utility of EEG and evoked potential data. Ann Neurol. 1979 Apr;5(4):309-21. doi: 10.1002/ana.410050402.
PMID: 443765
citation: Hughes JR, John ER. Conventional and quantitative electroencephalography in psychiatry. J Neuropsychiatry Clin Neurosci. 1999 Spring;11(2):190-208. doi: 10.1176/jnp.11.2.190.
PMID: 10333991
citation: Hoffman DA, Debattista C, Valuck RJ, Iosifescu DV. Measuring severe adverse events and medication selection using a "PEER Report" for nonpsychotic patients: a retrospective chart review. Neuropsychiatr Dis Treat. 2012;8:277-84. doi: 10.2147/NDT.S31665. Epub 2012 Jun 21.
PMID: 22802691
citation: Rush AJ, Bernstein IH, Trivedi MH, Carmody TJ, Wisniewski S, Mundt JC, Shores-Wilson K, Biggs MM, Woo A, Nierenberg AA, Fava M. An evaluation of the quick inventory of depressive symptomatology and the hamilton rating scale for depression: a sequenced treatment alternatives to relieve depression trial report. Biol Psychiatry. 2006 Mar 15;59(6):493-501. doi: 10.1016/j.biopsych.2005.08.022. Epub 2005 Sep 30.
PMID: 16199008
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: No
study doc: 
study doc: 