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

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ClinicalTrials.gov Identifier: NCT02522377
Recruitment Status : Completed
First Posted : August 13, 2015
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Murat Altinay, The Cleveland Clinic

Brief 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.


Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Major Depressive Disorder Severe Depression Drug: Ketamine Drug: Midazolam Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2015
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : March 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ketamine Infusions
Subjects who are randomized to be on this group will receive a standard dose of ketamine interleaved with Electroconvulsive Treatments.
Drug: Ketamine
inter venous injections
Other Names:
  • Ketalar
  • Calypsol
  • Ketanest
  • Tekam

Active Comparator: Midazolam
Subjects who are randomized to be on this group will receive midazolam infusions interleaved with Electroconvulsive Treatments.
Drug: Midazolam
inter venous injections
Other Names:
  • Dormicum
  • Hypnovel
  • Versed




Primary Outcome Measures :
  1. Hamilton Depression Rating Scale [ Time Frame: visit 17 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02522377


Locations
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United States, Ohio
Cleveland Clinic Foundation Center for Behavioral Health
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Murat Altinay, MD The Cleveland Clinic

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Responsible Party: Dr. Murat Altinay, Staff, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02522377     History of Changes
Other Study ID Numbers: Ketamine ECT
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dr. Murat Altinay, The Cleveland Clinic:
Ketamine
Electroconvulsive Therapy
Major Depressive Disorder
Treatment Resistant Depression
electroconvulsive treatment
Severe depression

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Ketamine
Midazolam
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents