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Administration of Subanesthetic Dose of Ketamine and Electroconvulsive Treatment for Treatment Resistant Depression

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ClinicalTrials.gov Identifier: NCT02522377
Recruitment Status : Completed
First Posted : August 13, 2015
Results First Posted : August 29, 2019
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Murat Altinay, The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE August 7, 2015
First Posted Date  ICMJE August 13, 2015
Results First Submitted Date  ICMJE June 27, 2019
Results First Posted Date  ICMJE August 29, 2019
Last Update Posted Date August 29, 2019
Study Start Date  ICMJE August 2015
Actual Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2019)
  • Hamilton Depression Rating Scale (HAMD-17) at Last Infusion [ Time Frame: visit 17 ]
    Change in HAMD-17 at Infusion 6. Scores range from 0 to 50, with higher scores representing more depression.
  • Montgomery Asberg Depression Rating Scale (MADRS) at Last Infusion [ Time Frame: visit 17 ]
    Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60
Original Primary Outcome Measures  ICMJE
 (submitted: August 12, 2015)
Hamilton Depression Rating Scale [ Time Frame: visit 17 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2019)
  • Montreal Cognitive Assessment (MOCA) at Last Infusion [ Time Frame: visit 17 ]
    MoCA scores range between 0 and 30. Higher scores reflect higher cognition.
  • Hopkins Verbal Learning Test - Revised (HVLT-R) at Last Infusion [ Time Frame: visit 17 ]
    The number of words remembered are recorded. Scores range from 0 to 12 with higher scores reflecting better acquisition.
  • Controlled Oral Word Association Test (COWAT) at Last Infusion [ Time Frame: visit 17 ]
    This is a verbal fluency measure. Outcome is the count of words that meet criteria within 1 minute, so the minimum is 0 and no fixed maximum exists. Higher scores reflect a better outcome.
  • Responder Rate on HAMD-17 by Last Infusion [ Time Frame: visit 17 ]
    Count of the patients who showed response (>50% decrease).
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Administration of Subanesthetic Dose of Ketamine and Electroconvulsive Treatment for Treatment Resistant Depression
Official Title  ICMJE Administration of Subanesthetic Dose of Ketamine and Electroconvulsive Treatment on Alternate Week Days in Patients With Treatment Resistant Depression: A Double Blind Placebo Controlled Trial
Brief Summary

In this proof of concept study, the investigators plan to administer iv ketamine interleaved with ECT days.

Patients with treatment resistant depression who are deemed to be eligible for ECT treatment will randomly be assigned to either ketamine or active placebo.

Detailed Description

The study will compare the effects of standard ketamine dosing with an active placebo arm.

Hypothesis 1:

The investigators hypothesize that interleaved Electroconvulsive Treatment and active ketamine treatment will lead to a meaningful clinical improvement compared to Electroconvulsive Treatment and placebo treatment arm.

Hypothesis 2:

The investigators hypothesize that interleaved Electroconvulsive Treatment and active ketamine treatment will attenuate cognitive side effects.

Methods and Design:

Patients with treatment resistant depression who are deemed to be eligible for Electroconvulsive Treatment will randomly be assigned to either ketamine or active placebo

Electroconvulsive Treatments:

All patients (independent of their depression scores) will receive the same Electroconvulsive Treatment parameters: Bi-frontal brief pulse (0.5 miliseconds) Electroconvulsive Treatment administered by using Thymatron Electroconvulsive Treatment machine.

Study blinding:

Neither the patients, nor the treating psychiatrist or the nurse will be aware of the patient's assigned arm. The success of blinding will be tested after each ketamine treatment with a questionnaire given to the subject, raters, and treating physician.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Treatment Resistant Depression
  • Major Depressive Disorder
  • Severe Depression
Intervention  ICMJE
  • Drug: Ketamine
    inter venous injections
    Other Names:
    • Ketalar
    • Calypsol
    • Ketanest
    • Tekam
  • Drug: Midazolam
    inter venous injections
    Other Names:
    • Dormicum
    • Hypnovel
    • Versed
Study Arms  ICMJE
  • Experimental: Ketamine Infusions
    Subjects who are randomized to be on this group will receive a standard dose of ketamine interleaved with Electroconvulsive Treatments.
    Intervention: Drug: Ketamine
  • Active Comparator: Midazolam
    Subjects who are randomized to be on this group will receive midazolam infusions interleaved with Electroconvulsive Treatments.
    Intervention: Drug: Midazolam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2019)
15
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2015)
10
Actual Study Completion Date  ICMJE March 1, 2018
Actual Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males/females at least 18 years of age but no older than 65 years of age
  2. Meet Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for Major Depression or Bipolar Disorder, depressed phase, as determined by a clinician's diagnostic evaluation and confirmed by interview using the Mini International Neuropsychiatric Interview (MINI PLUS 5.0.0)
  3. A current depressive episode that has lasted a minimum of 4 weeks.
  4. Have > 3 trials of antidepressants/augmentation strategies.
  5. Have a support system capable of transporting the patient post-treatment.

Exclusion Criteria:

  1. Meeting Diagnostic and Statistical Manual of Mental Disorders criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, pervasive developmental disorder.
  2. Meeting Diagnostic and Statistical Manual of Mental Disorders criteria for other substance/alcohol dependence within the past 6 months or abuse in the past 3 months.
  3. Patients who meet exclusion criteria for ketamine and/or midazolam infusion.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02522377
Other Study ID Numbers  ICMJE Ketamine ECT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Dr. Murat Altinay, The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Murat Altinay, MD The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP