<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/NCT02220309</url>
  </required_header>
  <id_info>
    <org_study_id>27937</org_study_id>
    <nct_id>NCT02220309</nct_id>
  </id_info>
  <brief_title>Stanford RAD-AT Study (Research on Anxiety and Depression - Anhedonia Treatment)</brief_title>
  <official_title>Neural Dimensions of Threat Reactivity and Regulation for Understanding Anxiety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study is aimed at understanding behaviors and brain circuits that relate to&#xD;
      anxiety and depression. Our goal is to learn which circuits of the brain are involved in&#xD;
      anxiety and how these circuits might affect daily functioning.&#xD;
&#xD;
      This study has recently added an additional treatment component: participants undergo a 12&#xD;
      week course of either Pramipexole medication or rTMS therapy (explained below). The ultimate&#xD;
      goal of the study is to offer participants experiencing anxiety and depression a treatment&#xD;
      that is alternative to ones that have failed them in the past, and to apply the knowledge we&#xD;
      gain from investigating the brain circuits involved in anxiety and depression to help&#xD;
      personalize treatments.&#xD;
&#xD;
      We invite anyone who has recently experienced any symptoms of anxiety and/or depression to&#xD;
      participate (no diagnosis is required to participate).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      If you are eligible and choose to participate, we'll ask you to come in for 2 separate&#xD;
      testing visits and 8 weeks of treatment in between.&#xD;
&#xD;
      In both the pre-treatment and post-treatment testing visit, you would complete game-like&#xD;
      tasks on the computer, undergo a non-invasive MRI brain scan, and answer some questions about&#xD;
      your emotional health. The entire visit takes place during 1-2 days at Stanford and lasts&#xD;
      about 4-5 hours. We'll also ask you to complete a follow-up 12 weeks later, from home, during&#xD;
      which we'll again ask you some questions on your emotional health.&#xD;
&#xD;
      The 8-week treatment phase will consist of your choice of either TMS (transcranial magnetic&#xD;
      stimulation) or Pramipexole (a medication for depression). You will meet with study&#xD;
      coordinators and MDs each week (Pramipexole) or each day (TMS) to receive treatment. You will&#xD;
      also be asked to complete weekly online surveys to monitor your mood during the 2-month&#xD;
      course of treatment.&#xD;
&#xD;
      To inquire more about participation, you can either sign up online or contact us.&#xD;
&#xD;
      Sign up online: http://med.stanford.edu/williamslab/research/current/rad.html Contact us:&#xD;
      Call or text (650) 600-1609 or email rad-at-study@stanford.edu&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Anticipated">April 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessments of symptoms and daily functioning</measure>
    <time_frame>12 weeks</time_frame>
    <description>General demographics questionnaires, alcohol use questionnaire, substance use questionnaires, Mood and Anxiety Symptom Questionnaire, Penn State Worry Questionnaire, Health at Work Performance Questionnaire, WHO Quality of Life questionnaire, Satisfaction with Life Survey, Emotion Regulation Questionnaire, Brief COPE questionnaire, Early Life Stress questionnaire, Quick Inventory of Depressive Symptomatology, Beck Depression Inventory, PTSD Checklist - Civilian Version, Beck Anxiety Inventory, Barratt Impulsiveness Scale, MINI Neuropsychiatric Interview</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brain imaging</measure>
    <time_frame>12 weeks</time_frame>
    <description>Non-invasive MRI brain scan to see function and structure of brain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive assessment</measure>
    <time_frame>12 weeks</time_frame>
    <description>WebNeuro is an objective assessment of cognitive strengths and weaknesses. It provides an accurate and objective assessment of person's cognitive function and efficiency.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Anxiety and mood disorders</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pramipexole Oral Tablet</intervention_name>
    <description>Pramipexole is an oral Dopamine agonist.</description>
    <arm_group_label>Anxiety and mood disorders</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      We will collect saliva samples, and in exploratory analysis focus on consideration of genes&#xD;
      associated with neuroimaging-behavior constructs.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        We expect to enroll 160 individuals spanning the spectrum of anxiety and associated mood&#xD;
        symptoms. These individuals include patients of the Gronowski Center, a community clinical&#xD;
        psychology center in Palo Alto. We will also recruit from the community through various&#xD;
        advertisements. Further, participants will include healthy people recruited by&#xD;
        advertisement.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Recent experiences of anxiety and/or depression&#xD;
&#xD;
          -  Ages 18-65&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Specific psychiatric medications (case-by-case basis)&#xD;
&#xD;
          -  A diagnosis of Bipolar 1 Disorder, Schizophrenia, or Obsessive Compulsive Disorder&#xD;
&#xD;
          -  Any of the following medical conditions: Parkinson's disease; liver or kidney disease;&#xD;
             history of epilepsy or seizures; history of cardiovascular disorders (specifically&#xD;
             orthostatic hypotension)&#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>Leanne M Williams, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gronowski Center-5150 El Camino Real</name>
      <address>
        <city>Los Altos</city>
        <state>California</state>
        <zip>94022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VAPAHCS/Palo Alto MIRECC-3801 Miranda Avenue</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University Department of Psychiatry</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://williamspanlab.com/rad</url>
    <description>Research on Anxiety and Depression: The RAD Project</description>
  </link>
  <link>
    <url>http://med.stanford.edu/williamslab/research/current/rad.html</url>
    <description>Research on Anxiety and Depression: The RAD Project</description>
  </link>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Leanne Williams</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Anxiety</keyword>
  <keyword>Depression</keyword>
  <keyword>Social Anxiety Disorder</keyword>
  <keyword>Bipolar disorder II</keyword>
  <keyword>PTSD</keyword>
  <keyword>GAD</keyword>
  <keyword>Phobia</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>Anxiety Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pramipexole</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02220309
org study id: 27937
nct id: NCT02220309
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This research study is aimed at understanding behaviors and brain circuits that relate to
      anxiety and depression. Our goal is to learn which circuits of the brain are involved in
      anxiety and how these circuits might affect daily functioning.

      This study has recently added an additional treatment component: participants undergo a 12
      week course of either Pramipexole medication or rTMS therapy (explained below). The ultimate
      goal of the study is to offer participants experiencing anxiety and depression a treatment
      that is alternative to ones that have failed them in the past, and to apply the knowledge we
      gain from investigating the brain circuits involved in anxiety and depression to help
      personalize treatments.

      We invite anyone who has recently experienced any symptoms of anxiety and/or depression to
      participate (no diagnosis is required to participate).
If you are eligible and choose to participate, we'll ask you to come in for 2 separate
      testing visits and 8 weeks of treatment in between.

      In both the pre-treatment and post-treatment testing visit, you would complete game-like
      tasks on the computer, undergo a non-invasive MRI brain scan, and answer some questions about
      your emotional health. The entire visit takes place during 1-2 days at Stanford and lasts
      about 4-5 hours. We'll also ask you to complete a follow-up 12 weeks later, from home, during
      which we'll again ask you some questions on your emotional health.

      The 8-week treatment phase will consist of your choice of either TMS (transcranial magnetic
      stimulation) or Pramipexole (a medication for depression). You will meet with study
      coordinators and MDs each week (Pramipexole) or each day (TMS) to receive treatment. You will
      also be asked to complete weekly online surveys to monitor your mood during the 2-month
      course of treatment.

      To inquire more about participation, you can either sign up online or contact us.

      Sign up online: http://med.stanford.edu/williamslab/research/current/rad.html Contact us:
      Call or text (650) 600-1609 or email rad-at-study@stanford.edu
observational model: Cohort
time perspective: Prospective
measure: Assessments of symptoms and daily functioning
time frame: 12 weeks
description: General demographics questionnaires, alcohol use questionnaire, substance use questionnaires, Mood and Anxiety Symptom Questionnaire, Penn State Worry Questionnaire, Health at Work Performance Questionnaire, WHO Quality of Life questionnaire, Satisfaction with Life Survey, Emotion Regulation Questionnaire, Brief COPE questionnaire, Early Life Stress questionnaire, Quick Inventory of Depressive Symptomatology, Beck Depression Inventory, PTSD Checklist - Civilian Version, Beck Anxiety Inventory, Barratt Impulsiveness Scale, MINI Neuropsychiatric Interview
measure: Brain imaging
time frame: 12 weeks
description: Non-invasive MRI brain scan to see function and structure of brain.
measure: Cognitive assessment
time frame: 12 weeks
description: WebNeuro is an objective assessment of cognitive strengths and weaknesses. It provides an accurate and objective assessment of person's cognitive function and efficiency.
arm group label: Anxiety and mood disorders
intervention type: Drug
intervention name: Pramipexole Oral Tablet
description: Pramipexole is an oral Dopamine agonist.
arm group label: Anxiety and mood disorders
We will collect saliva samples, and in exploratory analysis focus on consideration of genes
      associated with neuroimaging-behavior constructs.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Leanne M Williams, PhD
role: Principal Investigator
affiliation: Stanford University
facility: 
facility: 
facility: 
country: United States
url: http://williamspanlab.com/rad
description: Research on Anxiety and Depression: The RAD Project
url: http://med.stanford.edu/williamslab/research/current/rad.html
description: Research on Anxiety and Depression: The RAD Project
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Leanne Williams
investigator title: Professor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Anxiety Disorders
mesh term: Pramipexole