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

The Cleveland Clinic15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Treatment Resistant Depression Major Depressive Disorder Severe Depression

Interventions

KetamineDRUG

inter venous injections

MidazolamDRUG

inter venous injections

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cleveland Clinic Foundation Center for Behavioral Health

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: visit 17

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

Time frame: visit 17

Secondary Outcomes

Montreal Cognitive Assessment (MOCA) at Last Infusion

MoCA scores range between 0 and 30. Higher scores reflect higher cognition.

Time frame: visit 17

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.

Time frame: visit 17

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.

Time frame: visit 17

Responder Rate on HAMD-17 by Last Infusion

Count of the patients who showed response (\>50% decrease).

Time frame: visit 17

Data from ClinicalTrials.gov

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