Cleveland, Ohio 44195


Purpose:

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.


Study summary:

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.


Criteria:

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.


NCT ID:

NCT02522377


Primary Contact:

Principal Investigator
Murat Altinay, MD
The Cleveland Clinic

Murat Altinay, MD
Phone: 216-445-3359
Email: altinam@ccf.org


Backup Contact:

Email: morrisa15@ccf.org
Amy L Morrison
Phone: 216-445-2378


Location Contact:

Cleveland, Ohio 44195
United States

Murat Altinay, MD
Phone: 216-445-3359
Email: altinam@ccf.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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