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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02522377
Other study ID # Ketamine ECT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2015
Est. completion date March 1, 2018

Study information

Verified date August 2019
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date March 1, 2018
Est. primary completion date March 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Intervention

Drug:
Ketamine
inter venous injections
Midazolam
inter venous injections

Locations

Country Name City State
United States Cleveland Clinic Foundation Center for Behavioral Health Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. visit 17
Primary 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 visit 17
Secondary Montreal Cognitive Assessment (MOCA) at Last Infusion MoCA scores range between 0 and 30. Higher scores reflect higher cognition. visit 17
Secondary 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. visit 17
Secondary 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. visit 17
Secondary Responder Rate on HAMD-17 by Last Infusion Count of the patients who showed response (>50% decrease). visit 17
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