<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/NCT02238730</url>
  </required_header>
  <id_info>
    <org_study_id>KPSC IRB10133</org_study_id>
    <secondary_id>KPSC IRB 10133</secondary_id>
    <nct_id>NCT02238730</nct_id>
  </id_info>
  <brief_title>Ultrabrief Right Unilateral and Brief Pulse Bitemporal Electroconvulsive Therapy</brief_title>
  <official_title>Comparative Efficacy and Cognitive Side-Effects of Ultrabrief Right Unilateral Electroconvulsive Therapy and Brief Pulse Bitemporal Electroconvulsive Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaiser Permanente</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the equivalent efficacy of ultrabrief pulsewidth right unilateral&#xD;
      electroconvulsive therapy versus bitemporal brief pulse electroconvulsive therapy in the&#xD;
      treatment of depression and to evaluate the cognitive effects of ultrabrief right unilateral&#xD;
      electroconvulsive therapy versus bitemporal brief pulse electroconvulsive therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be randomized to either bitemporal brief pulse electroconvulsive therapy ( 0.5&#xD;
      ms pulse width) or right unilateral ultrabrief pulse electroconvulsive therapy for the first&#xD;
      six treatments. If further treatment is necessary, electrode placement will be chosen by the&#xD;
      treating psychiatrist. All electroconvulsive therapy treatments will be performed with a&#xD;
      Thymatron System IV instrument. (Somatics, LLC, Lake Bluff, Illinois, USA) Pre-&#xD;
      electroconvulsive therapy testing will occur within one week of beginning treatment.&#xD;
      Post-electroconvulsive therapy testing will occur within 48 hours of the 6th treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Resources not available for the study&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">February 15, 2017</completion_date>
  <primary_completion_date type="Actual">February 15, 2017</primary_completion_date>
  <phase>N/A</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>
  </study_design_info>
  <primary_outcome>
    <measure>Hamilton Depression Rating Scale (HAMD)</measure>
    <time_frame>up to 2-3 weeks</time_frame>
    <description>Standardized assessment administered by a psychologist</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mini Mental Status Examination</measure>
    <time_frame>up to 2-3 weeks</time_frame>
    <description>Standardized assessment administered by a psychologist</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Depression</condition>
  <condition>Depressive Disorder</condition>
  <condition>Treatment Resistant Depressive Disorder</condition>
  <condition>Bipolar Disorder</condition>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>Ultrabrief Right Unilateral</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ultrabrief (0.25 ms) Right Unilateral Electroconvulsive Therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brief Pulse Bitemporal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Brief Pulse (0.5 ms) Bitemporal Electroconvulsive Therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrabrief Right Unilateral</intervention_name>
    <description>The first six electroconvulsive therapy sessions using ultrabrief (0.25 ms) right unilateral electroconvulsive therapy</description>
    <arm_group_label>Ultrabrief Right Unilateral</arm_group_label>
    <other_name>Thymatron System IV</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Brief Pulse Bitemporal</intervention_name>
    <description>The first six electroconvulsive therapy sessions using brief pulse (0.5 ms) bitemporal electroconvulsive therapy</description>
    <arm_group_label>Brief Pulse Bitemporal</arm_group_label>
    <other_name>Thymatron System IV</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients age 18 and above referred for electroconvulsive therapy will be screened&#xD;
             for eligibility for participation in this study.&#xD;
&#xD;
          -  Basic competency in English&#xD;
&#xD;
          -  Diagnosis of either of the following:&#xD;
&#xD;
               1. Major Depressive Disorder, Single Episode&#xD;
&#xD;
               2. Major Depressive Disorder, Recurrent&#xD;
&#xD;
               3. Bipolar Disorder, Currently Depressed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-existing cognitive impairment with an initial Mini Mental Status Exam Score of 24&#xD;
             or lower&#xD;
&#xD;
          -  Major neurological disease&#xD;
&#xD;
          -  Other medical conditions making electroconvulsive therapy an excessive risk to be&#xD;
             completed safely in an outpatient surgery center and anticonvulsant therapy.&#xD;
&#xD;
          -  Pregnancy&#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>Ronad L Warnell, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kaiser Permanente</affiliation>
  </overall_official>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>February 15, 2017</last_update_submitted>
  <last_update_submitted_qc>February 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Depression</keyword>
  <keyword>Depressive Disorder</keyword>
  <keyword>Treatment Resistant Depressive Disorder</keyword>
  <keyword>Bipolar Disorder</keyword>
  <keyword>Major Depressive Disorder</keyword>
  <keyword>Electroconvulsive therapy</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>
    <mesh_term>Bipolar Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Treatment-Resistant</mesh_term>
  </condition_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/NCT02238730
org study id: KPSC IRB10133
secondary id: KPSC IRB 10133
nct id: NCT02238730
lead sponsor: 
has dmc: Yes
To evaluate the equivalent efficacy of ultrabrief pulsewidth right unilateral
      electroconvulsive therapy versus bitemporal brief pulse electroconvulsive therapy in the
      treatment of depression and to evaluate the cognitive effects of ultrabrief right unilateral
      electroconvulsive therapy versus bitemporal brief pulse electroconvulsive therapy.
Patients will be randomized to either bitemporal brief pulse electroconvulsive therapy ( 0.5
      ms pulse width) or right unilateral ultrabrief pulse electroconvulsive therapy for the first
      six treatments. If further treatment is necessary, electrode placement will be chosen by the
      treating psychiatrist. All electroconvulsive therapy treatments will be performed with a
      Thymatron System IV instrument. (Somatics, LLC, Lake Bluff, Illinois, USA) Pre-
      electroconvulsive therapy testing will occur within one week of beginning treatment.
      Post-electroconvulsive therapy testing will occur within 48 hours of the 6th treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Hamilton Depression Rating Scale (HAMD)
time frame: up to 2-3 weeks
description: Standardized assessment administered by a psychologist
measure: Mini Mental Status Examination
time frame: up to 2-3 weeks
description: Standardized assessment administered by a psychologist
arm group label: Ultrabrief Right Unilateral
arm group type: Active Comparator
description: Ultrabrief (0.25 ms) Right Unilateral Electroconvulsive Therapy
arm group label: Brief Pulse Bitemporal
arm group type: Active Comparator
description: Brief Pulse (0.5 ms) Bitemporal Electroconvulsive Therapy
intervention type: Device
intervention name: Ultrabrief Right Unilateral
description: The first six electroconvulsive therapy sessions using ultrabrief (0.25 ms) right unilateral electroconvulsive therapy
arm group label: Ultrabrief Right Unilateral
other name: Thymatron System IV
intervention type: Device
intervention name: Brief Pulse Bitemporal
description: The first six electroconvulsive therapy sessions using brief pulse (0.5 ms) bitemporal electroconvulsive therapy
arm group label: Brief Pulse Bitemporal
other name: Thymatron System IV
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ronad L Warnell, MD
role: Principal Investigator
affiliation: Kaiser Permanente
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major
mesh term: Bipolar Disorder
mesh term: Depressive Disorder, Treatment-Resistant