Back to resultsAdministration of Subanesthetic Dose of Ketamine and Electroconvulsive Treatment for Treatment Resistant Depression
Primary Purpose
Treatment Resistant Depression, Major Depressive Disorder, Severe Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Midazolam
Sponsored by
About this trial
This is an interventional treatment trial for Treatment Resistant Depression focused on measuring Ketamine, Electroconvulsive Therapy, Major Depressive Disorder, Treatment Resistant Depression, electroconvulsive treatment, Severe depression
Eligibility Criteria
Inclusion Criteria:
- Males/females at least 18 years of age but no older than 65 years of age
- 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)
- A current depressive episode that has lasted a minimum of 4 weeks.
- Have > 3 trials of antidepressants/augmentation strategies.
- Have a support system capable of transporting the patient post-treatment.
Exclusion Criteria:
- Meeting Diagnostic and Statistical Manual of Mental Disorders criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, pervasive developmental disorder.
- 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.
- Patients who meet exclusion criteria for ketamine and/or midazolam infusion.
Sites / Locations
- Cleveland Clinic Foundation Center for Behavioral Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ketamine Infusions
Midazolam
Arm Description
Subjects who are randomized to be on this group will receive a standard dose of ketamine interleaved with Electroconvulsive Treatments.
Subjects who are randomized to be on this group will receive midazolam infusions interleaved with Electroconvulsive Treatments.
Outcomes
Primary Outcome Measures
Hamilton Depression Rating Scale (HAMD-17) at Last Infusion
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
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
Secondary Outcome Measures
Montreal Cognitive Assessment (MOCA) at Last Infusion
MoCA scores range between 0 and 30. Higher scores reflect higher cognition.
Hopkins Verbal Learning Test - Revised (HVLT-R) at Last Infusion
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
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
Count of the patients who showed response (>50% decrease).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02522377
Brief Title
Administration of Subanesthetic Dose of Ketamine and Electroconvulsive Treatment for Treatment Resistant Depression
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
March 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression, Major Depressive Disorder, Severe Depression
Keywords
Ketamine, Electroconvulsive Therapy, Major Depressive Disorder, Treatment Resistant Depression, electroconvulsive treatment, Severe depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketamine Infusions
Arm Type
Experimental
Arm Description
Subjects who are randomized to be on this group will receive a standard dose of ketamine interleaved with Electroconvulsive Treatments.
Arm Title
Midazolam
Arm Type
Active Comparator
Arm Description
Subjects who are randomized to be on this group will receive midazolam infusions interleaved with Electroconvulsive Treatments.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketalar, Calypsol, Ketanest, Tekam
Intervention Description
inter venous injections
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Dormicum, Hypnovel, Versed
Intervention Description
inter venous injections
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale (HAMD-17) at Last Infusion
Description
Change in HAMD-17 at Infusion 6. Scores range from 0 to 50, with higher scores representing more depression.
Time Frame
visit 17
Title
Montgomery Asberg Depression Rating Scale (MADRS) at Last Infusion
Description
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
Time Frame
visit 17
Secondary Outcome Measure Information:
Title
Montreal Cognitive Assessment (MOCA) at Last Infusion
Description
MoCA scores range between 0 and 30. Higher scores reflect higher cognition.
Time Frame
visit 17
Title
Hopkins Verbal Learning Test - Revised (HVLT-R) at Last Infusion
Description
The number of words remembered are recorded. Scores range from 0 to 12 with higher scores reflecting better acquisition.
Time Frame
visit 17
Title
Controlled Oral Word Association Test (COWAT) at Last Infusion
Description
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.
Time Frame
visit 17
Title
Responder Rate on HAMD-17 by Last Infusion
Description
Count of the patients who showed response (>50% decrease).
Time Frame
visit 17
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males/females at least 18 years of age but no older than 65 years of age
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)
A current depressive episode that has lasted a minimum of 4 weeks.
Have > 3 trials of antidepressants/augmentation strategies.
Have a support system capable of transporting the patient post-treatment.
Exclusion Criteria:
Meeting Diagnostic and Statistical Manual of Mental Disorders criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, pervasive developmental disorder.
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.
Patients who meet exclusion criteria for ketamine and/or midazolam infusion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murat Altinay, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation Center for Behavioral Health
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Administration of Subanesthetic Dose of Ketamine and Electroconvulsive Treatment for Treatment Resistant Depression
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