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
Last Update Posted : March 29, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Treatment Resistant Depression Major Depressive Disorder Severe Depression||Drug: Ketamine Drug: Midazolam||Not Applicable|
The study will compare the effects of standard ketamine dosing with an active placebo arm.
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.
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
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.
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||August 2015|
|Actual Primary Completion Date :||March 1, 2018|
|Actual Study Completion Date :||March 1, 2018|
Experimental: Ketamine Infusions
Subjects who are randomized to be on this group will receive a standard dose of ketamine interleaved with Electroconvulsive Treatments.
inter venous injections
Active Comparator: Midazolam
Subjects who are randomized to be on this group will receive midazolam infusions interleaved with Electroconvulsive Treatments.
inter venous injections
- Hamilton Depression Rating Scale [ Time Frame: visit 17 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02522377
|United States, Ohio|
|Cleveland Clinic Foundation Center for Behavioral Health|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Murat Altinay, MD||The Cleveland Clinic|