Administration of Subanesthetic Dose of Ketamine and Electroconvulsive Treatment for Treatment Resistant Depression
| Status: | Completed |
|---|---|
| Conditions: | Depression, Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/17/2018 |
| Start Date: | August 2015 |
| End Date: | March 1, 2018 |
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.
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.
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.
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.
We found this trial at
1
site
Cleveland, Ohio 44195
Principal Investigator: Murat Altinay, MD
Phone: 216-445-3359
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