<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/NCT01717508</url>
  </required_header>
  <id_info>
    <org_study_id>2012P001844</org_study_id>
    <secondary_id>2011A053424</secondary_id>
    <secondary_id>2011A051965</secondary_id>
    <secondary_id>2010A054978</secondary_id>
    <secondary_id>K23MH097786</secondary_id>
    <nct_id>NCT01717508</nct_id>
  </id_info>
  <brief_title>Neural Components Underlying the Treatment of Adolescent Depression</brief_title>
  <official_title>Examination of the Neural Components Underlying the Treatment of Adolescent Major Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mclean Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Mclean Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of the study is to examine how cognitive behavioral therapy (CBT), a common&#xD;
      treatment for adolescent depression, affects brain functioning. Depressed adolescents will&#xD;
      complete an initial assessment consisting of an interview, questionnaires, computer tasks,&#xD;
      and an EEG recording. EEG (electroencephalography) measures brain activity by recording the&#xD;
      electrical activity along the scalp caused by the firing of neurons within the brain. They&#xD;
      will then complete 12 sessions of cognitive behavioral therapy, which will be 50 minutes long&#xD;
      and held once a week for 12 weeks. Before their third therapy session, participants will&#xD;
      complete a computer task while EEG data are recorded. After completing the treatment, the&#xD;
      participants will complete a final assessment, which will include questionnaires, computer&#xD;
      tasks, and an EEG recording. They will also complete follow-up assessments over the phone 1,&#xD;
      3, and 6 months after completing the treatment.&#xD;
&#xD;
      This study will also include healthy control participants. They will complete an initial&#xD;
      assessment consisting of an interview, questionnaires, computer tasks, and an EEG recording.&#xD;
      Three weeks later, they will return to complete a behavioral task while EEG data are&#xD;
      recorded. Twelve weeks after the initial assessment, they will complete a final assessment,&#xD;
      which will include questionnaires, computer tasks, and an EEG recording.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is to examine the impact of individual cognitive behavioral therapy&#xD;
      (CBT) for adolescent depression on neural functioning. Specifically, the study will utilize&#xD;
      Brent and Poling's (1997) cognitive behavioral therapy (CBT) manual (Cognitive Therapy&#xD;
      Treatment Manual for Depressed and Suicidal Youth), and investigators will examine pre- to&#xD;
      post- neural activity patterns for children and adolescents who receive individual CBT for&#xD;
      depression. Electroencephalography (EEG) techniques will be utilized to assess&#xD;
      treatment-related effects on brain activity (i.e., anterior cingulate cortex and dorsolateral&#xD;
      prefrontal cortex functioning). Neural activity patterns will also be compared to&#xD;
      non-depressed, healthy controls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>EEG Activity</measure>
    <time_frame>12 weeks</time_frame>
    <description>EEG and ERP measures collected during resting state and behavioral tasks</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">112</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>Cognitive Behavioral Therapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>12 weekly sessions of cognitive behavioral therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioral Therapy</intervention_name>
    <description>12 sessions of cognitive behavioral therapy</description>
    <arm_group_label>Cognitive Behavioral Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria, Major Depressive Disorder Participants:&#xD;
&#xD;
          -  Ages 13-18 years at time of initial assessment&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Current major depressive disorder (MDD) diagnosed according to the K-SADS Axis I&#xD;
             semi-structured interview&#xD;
&#xD;
          -  English as first language or English fluency&#xD;
&#xD;
        Exclusion Criteria, Major Depressive Disorder Participants:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Mania/Hypomania&#xD;
&#xD;
          -  Current anxiety disorders [e.g., Panic Disorder (PD), Generalized Anxiety Disorder&#xD;
             (GAD), Obsessive Compulsive Disorder (OCD)]&#xD;
&#xD;
          -  Eating Disorders&#xD;
&#xD;
          -  Substance Abuse/Dependency&#xD;
&#xD;
          -  Conduct Disorder/Antisocial Disorder&#xD;
&#xD;
          -  ADHD&#xD;
&#xD;
          -  Psychosis&#xD;
&#xD;
          -  Mental Retardation&#xD;
&#xD;
          -  Organic Brain Syndrome&#xD;
&#xD;
          -  Current Psychotherapy Treatment&#xD;
&#xD;
          -  Medical &amp; neurological illness (head injury, loss of consciousness for more than 5&#xD;
             minutes, seizures)&#xD;
&#xD;
          -  Current use of psychotropic medication for treatment of MDD with the exception of&#xD;
             SSRIs (selective serotonin reuptake inhibitors)&#xD;
&#xD;
          -  Active suicidality&#xD;
&#xD;
        Inclusion Criteria, Healthy Control Participants:&#xD;
&#xD;
          -  Ages 13-18 years at time of initial assessment&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  English as first language or English fluency&#xD;
&#xD;
        Exclusion Criteria, Healthy Control Participants (in addition to the exclusion criteria of&#xD;
        the MDD group):&#xD;
&#xD;
          -  Elevated depressive symptoms as assessed in phone screen&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Randy P Auerbach, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mclean Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>McLean Hospital</name>
      <address>
        <city>Belmont</city>
        <state>Massachusetts</state>
        <zip>02478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>February 21, 2020</last_update_submitted>
  <last_update_submitted_qc>February 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mclean Hospital</investigator_affiliation>
    <investigator_full_name>Randy P. Auerbach</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>MDD</keyword>
  <keyword>depression</keyword>
  <keyword>major depressive disorder</keyword>
  <keyword>adolescent</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>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT01717508
org study id: 2012P001844
secondary id: 2011A053424
secondary id: 2011A051965
secondary id: 2010A054978
secondary id: K23MH097786
nct id: NCT01717508
lead sponsor: 
collaborator: 
has dmc: No
The goal of the study is to examine how cognitive behavioral therapy (CBT), a common
      treatment for adolescent depression, affects brain functioning. Depressed adolescents will
      complete an initial assessment consisting of an interview, questionnaires, computer tasks,
      and an EEG recording. EEG (electroencephalography) measures brain activity by recording the
      electrical activity along the scalp caused by the firing of neurons within the brain. They
      will then complete 12 sessions of cognitive behavioral therapy, which will be 50 minutes long
      and held once a week for 12 weeks. Before their third therapy session, participants will
      complete a computer task while EEG data are recorded. After completing the treatment, the
      participants will complete a final assessment, which will include questionnaires, computer
      tasks, and an EEG recording. They will also complete follow-up assessments over the phone 1,
      3, and 6 months after completing the treatment.

      This study will also include healthy control participants. They will complete an initial
      assessment consisting of an interview, questionnaires, computer tasks, and an EEG recording.
      Three weeks later, they will return to complete a behavioral task while EEG data are
      recorded. Twelve weeks after the initial assessment, they will complete a final assessment,
      which will include questionnaires, computer tasks, and an EEG recording.
The purpose of the study is to examine the impact of individual cognitive behavioral therapy
      (CBT) for adolescent depression on neural functioning. Specifically, the study will utilize
      Brent and Poling's (1997) cognitive behavioral therapy (CBT) manual (Cognitive Therapy
      Treatment Manual for Depressed and Suicidal Youth), and investigators will examine pre- to
      post- neural activity patterns for children and adolescents who receive individual CBT for
      depression. Electroencephalography (EEG) techniques will be utilized to assess
      treatment-related effects on brain activity (i.e., anterior cingulate cortex and dorsolateral
      prefrontal cortex functioning). Neural activity patterns will also be compared to
      non-depressed, healthy controls.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: EEG Activity
time frame: 12 weeks
description: EEG and ERP measures collected during resting state and behavioral tasks
arm group label: Cognitive Behavioral Therapy
arm group type: Other
description: 12 weekly sessions of cognitive behavioral therapy
arm group label: Healthy Controls
arm group type: No Intervention
intervention type: Behavioral
intervention name: Cognitive Behavioral Therapy
description: 12 sessions of cognitive behavioral therapy
arm group label: Cognitive Behavioral Therapy
criteria: 
gender: Female
minimum age: 13 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Randy P Auerbach, PhD
role: Principal Investigator
affiliation: Mclean Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mclean Hospital
investigator full name: Randy P. Auerbach
investigator title: Principal Investigator
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major
sharing ipd: No