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Ultrabrief Right Unilateral and Brief Pulse Bitemporal Electroconvulsive Therapy

Primary Purpose

Depression, Depressive Disorder, Treatment Resistant Depressive Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrabrief Right Unilateral
Brief Pulse Bitemporal
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Depressive Disorder, Treatment Resistant Depressive Disorder, Bipolar Disorder, Major Depressive Disorder, Electroconvulsive therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients age 18 and above referred for electroconvulsive therapy will be screened for eligibility for participation in this study.
  • Basic competency in English

  • Diagnosis of either of the following:

    1. Major Depressive Disorder, Single Episode
    2. Major Depressive Disorder, Recurrent
    3. Bipolar Disorder, Currently Depressed

Exclusion Criteria:

  • Pre-existing cognitive impairment with an initial Mini Mental Status Exam Score of 24 or lower
  • Major neurological disease
  • Other medical conditions making electroconvulsive therapy an excessive risk to be completed safely in an outpatient surgery center and anticonvulsant therapy.
  • Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Ultrabrief Right Unilateral

    Brief Pulse Bitemporal

    Arm Description

    Ultrabrief (0.25 ms) Right Unilateral Electroconvulsive Therapy

    Brief Pulse (0.5 ms) Bitemporal Electroconvulsive Therapy

    Outcomes

    Primary Outcome Measures

    Hamilton Depression Rating Scale (HAMD)
    Standardized assessment administered by a psychologist

    Secondary Outcome Measures

    Mini Mental Status Examination
    Standardized assessment administered by a psychologist

    Full Information

    First Posted
    September 10, 2014
    Last Updated
    February 15, 2017
    Sponsor
    Kaiser Permanente
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02238730
    Brief Title
    Ultrabrief Right Unilateral and Brief Pulse Bitemporal Electroconvulsive Therapy
    Official Title
    Comparative Efficacy and Cognitive Side-Effects of Ultrabrief Right Unilateral Electroconvulsive Therapy and Brief Pulse Bitemporal Electroconvulsive Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Resources not available for the study
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    February 15, 2017 (Actual)
    Study Completion Date
    February 15, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kaiser Permanente

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression, Depressive Disorder, Treatment Resistant Depressive Disorder, Bipolar Disorder, Major Depressive Disorder
    Keywords
    Depression, Depressive Disorder, Treatment Resistant Depressive Disorder, Bipolar Disorder, Major Depressive Disorder, Electroconvulsive therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ultrabrief Right Unilateral
    Arm Type
    Active Comparator
    Arm Description
    Ultrabrief (0.25 ms) Right Unilateral Electroconvulsive Therapy
    Arm Title
    Brief Pulse Bitemporal
    Arm Type
    Active Comparator
    Arm Description
    Brief Pulse (0.5 ms) Bitemporal Electroconvulsive Therapy
    Intervention Type
    Device
    Intervention Name(s)
    Ultrabrief Right Unilateral
    Other Intervention Name(s)
    Thymatron System IV
    Intervention Description
    The first six electroconvulsive therapy sessions using ultrabrief (0.25 ms) right unilateral electroconvulsive therapy
    Intervention Type
    Device
    Intervention Name(s)
    Brief Pulse Bitemporal
    Other Intervention Name(s)
    Thymatron System IV
    Intervention Description
    The first six electroconvulsive therapy sessions using brief pulse (0.5 ms) bitemporal electroconvulsive therapy
    Primary Outcome Measure Information:
    Title
    Hamilton Depression Rating Scale (HAMD)
    Description
    Standardized assessment administered by a psychologist
    Time Frame
    up to 2-3 weeks
    Secondary Outcome Measure Information:
    Title
    Mini Mental Status Examination
    Description
    Standardized assessment administered by a psychologist
    Time Frame
    up to 2-3 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients age 18 and above referred for electroconvulsive therapy will be screened for eligibility for participation in this study. Basic competency in English Diagnosis of either of the following: Major Depressive Disorder, Single Episode Major Depressive Disorder, Recurrent Bipolar Disorder, Currently Depressed Exclusion Criteria: Pre-existing cognitive impairment with an initial Mini Mental Status Exam Score of 24 or lower Major neurological disease Other medical conditions making electroconvulsive therapy an excessive risk to be completed safely in an outpatient surgery center and anticonvulsant therapy. Pregnancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ronad L Warnell, MD
    Organizational Affiliation
    Kaiser Permanente
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Ultrabrief Right Unilateral and Brief Pulse Bitemporal Electroconvulsive Therapy

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