Administration of Subanesthetic Dose of Ketamine and Electroconvulsive Treatment for Treatment Resistant Depression
Information source: The Cleveland Clinic
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Treatment Resistant Depression; Major Depressive Disorder; Severe Depression
Intervention: Ketamine (Drug); Midazolam (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: The Cleveland Clinic Official(s) and/or principal investigator(s): Murat Altinay, MD, Principal Investigator, Affiliation: The Cleveland Clinic
Overall contact: Murat Altinay, MD, Phone: 216-445-3359, Email: altinam@ccf.org
Summary
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Hamilton Depression Rating Scale
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Murat Altinay, MD, Phone: 216-445-3359, Email: altinam@ccf.org
Cleveland Clinic Foundation Center for Behavioral Health, Cleveland, Ohio 44195, United States; Not yet recruiting Murat Altinay, MD, Phone: 216-445-3359, Email: altinam@ccf.org Adrienna Easterling, BS, Phone: 216-445-2378, Email: wintera@ccf.org Murat Altinay, MD, Principal Investigator
Additional Information
Starting date: August 2015
Last updated: August 12, 2015
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