Major Depressive Disorder Clinical Trial
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
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.
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.
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