<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/NCT01667744</url>
  </required_header>
  <id_info>
    <org_study_id>11146121</org_study_id>
    <nct_id>NCT01667744</nct_id>
  </id_info>
  <brief_title>Citalopram for Sx/Util in Acute Coronary Syndrome Patients</brief_title>
  <official_title>Citalopram for Sx/Util in Acute Coronary Syndrome Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henry Ford Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Henry Ford Health System</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Symptoms (chest pain, shortness of breath, dizziness, etc.) and treatment usage (doctor or&#xD;
      emergency room visits, testing, hospital days, etc.) in patients with Acute Coronary&#xD;
      Syndromes are known to be related to emotional distress (Anxiety, Depression and Anger). In&#xD;
      addition, behavioral treatment of emotional distress is known to decrease symptoms, and&#xD;
      treatment usage. The present protocol tests whether the addition of a medication known to&#xD;
      reduce emotional distress can also reduce symptoms and treatment usage.&#xD;
&#xD;
      This will done by recruiting patients with ACS during their hospital stay, randomizing them&#xD;
      to receive citalopram or placebo, and then examining their symptoms and treatment usage at 6&#xD;
      months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Not applicable. Study not funded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    unfunded&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 1, 2016</start_date>
  <completion_date type="Actual">February 16, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2016</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of ACS Symptoms</measure>
    <time_frame>6 months</time_frame>
    <description>Frequency of episiodes of chest pain, presyncope, dyspnea, fatigue and palpitations</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment usage</measure>
    <time_frame>6 months</time_frame>
    <description>ER Visits, Hospital Days, Catheterizations, PTCAs/CABGs, Valve Surgery, AICD/Pacemaker, Treadmills, Echos, Nuclear Scans, Chest X-Rays</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Emotional Distress</measure>
    <time_frame>6 months</time_frame>
    <description>Depression per PHQ9, Anxiety per GAD7 &amp; Anxiety/Depression/AIAI per KSSFC</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo pill</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Citalopram</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Citalopram</intervention_name>
    <description>10 mg/day</description>
    <arm_group_label>Citalopram</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admission to hospital for chest pain/dyspnea, typical ECG changes plus positive&#xD;
             tropinins&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age less than 18&#xD;
&#xD;
          -  cognitive impairment (per MMSE)&#xD;
&#xD;
          -  geographic unavailability for followup&#xD;
&#xD;
          -  unwillingness to participate&#xD;
&#xD;
          -  illiteracy&#xD;
&#xD;
          -  Hx cardiac transplant&#xD;
&#xD;
          -  untreated hypothyroidism&#xD;
&#xD;
          -  hepatic dysfunction&#xD;
&#xD;
          -  prior adverse reaction to citalopram&#xD;
&#xD;
          -  history of Bipolar Disorder&#xD;
&#xD;
          -  untreated Sleep Apnea&#xD;
&#xD;
          -  chronic steroid therapy&#xD;
&#xD;
          -  active substance abuse (e.g., within past year)&#xD;
&#xD;
          -  near term mortal illness&#xD;
&#xD;
          -  current mental health treatment&#xD;
&#xD;
          -  signitificant suicide risk&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark W Ketterer, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Henry Ford Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>August 12, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>December 7, 2022</last_update_submitted>
  <last_update_submitted_qc>December 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Henry Ford Health System</investigator_affiliation>
    <investigator_full_name>Mark W. Ketterer, PhD</investigator_full_name>
    <investigator_title>Senior Bioscientific Staff</investigator_title>
  </responsible_party>
  <keyword>Angina</keyword>
  <keyword>Acute Coronary Syndrome</keyword>
  <keyword>Emotional Distress</keyword>
  <keyword>Citalopram</keyword>
  <keyword>Health Care Utilization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Citalopram</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Study not funded.</ipd_description>
  </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/NCT01667744
org study id: 11146121
nct id: NCT01667744
lead sponsor: 
has dmc: Yes
Symptoms (chest pain, shortness of breath, dizziness, etc.) and treatment usage (doctor or
      emergency room visits, testing, hospital days, etc.) in patients with Acute Coronary
      Syndromes are known to be related to emotional distress (Anxiety, Depression and Anger). In
      addition, behavioral treatment of emotional distress is known to decrease symptoms, and
      treatment usage. The present protocol tests whether the addition of a medication known to
      reduce emotional distress can also reduce symptoms and treatment usage.

      This will done by recruiting patients with ACS during their hospital stay, randomizing them
      to receive citalopram or placebo, and then examining their symptoms and treatment usage at 6
      months.
Not applicable. Study not funded.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Frequency of ACS Symptoms
time frame: 6 months
description: Frequency of episiodes of chest pain, presyncope, dyspnea, fatigue and palpitations
measure: Treatment usage
time frame: 6 months
description: ER Visits, Hospital Days, Catheterizations, PTCAs/CABGs, Valve Surgery, AICD/Pacemaker, Treadmills, Echos, Nuclear Scans, Chest X-Rays
measure: Emotional Distress
time frame: 6 months
description: Depression per PHQ9, Anxiety per GAD7 & Anxiety/Depression/AIAI per KSSFC
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo pill
arm group label: Citalopram
arm group type: Experimental
description: Drug
intervention type: Drug
intervention name: Citalopram
description: 10 mg/day
arm group label: Citalopram
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark W Ketterer, PhD
role: Principal Investigator
affiliation: Henry Ford Health System
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Henry Ford Health System
investigator full name: Mark W. Ketterer, PhD
investigator title: Senior Bioscientific Staff
mesh term: Acute Coronary Syndrome
mesh term: Syndrome
mesh term: Citalopram
sharing ipd: Undecided
ipd description: Study not funded.