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Completed

NCT Number: NCT02522377

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

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.

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Key information

Conditions

Treatment Resistant Depression Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Depressive Disorder, Treatment-Resistant Major Depressive Disorder Mental Disorders Mood Disorders Severe Depression

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation Center for Behavioral Health

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males/females at least 18 years of age but no older than 65 years of age
  • 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)
  • A current depressive episode that has lasted a minimum of 4 weeks.
  • Have > 3 trials of antidepressants/augmentation strategies.
  • Have a support system capable of transporting the patient post-treatment.

Exclusion criteria

  • Meeting Diagnostic and Statistical Manual of Mental Disorders criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, pervasive developmental disorder.
  • 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.
  • Patients who meet exclusion criteria for ketamine and/or midazolam infusion.

Treatment and study plan

ketamine

Drug

inter venous injections

Other names: Ketalar, Calypsol, Ketanest, Tekam

midazolam

Drug

inter venous injections

Other names: Dormicum, Hypnovel, Versed

Primary outcomes

  1. Hamilton Depression Rating Scale (HAMD-17) at Last Infusion

    Time frame: visit 17

    Change in HAMD-17 at Infusion 6. Scores range from 0 to 50, with higher scores representing more depression.

  2. Montgomery Asberg Depression Rating Scale (MADRS) at Last Infusion

    Time frame: visit 17

    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

Secondary outcomes

  1. Montreal Cognitive Assessment (MOCA) at Last Infusion

    Time frame: visit 17

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

  2. Hopkins Verbal Learning Test - Revised (HVLT-R) at Last Infusion

    Time frame: visit 17

    The number of words remembered are recorded. Scores range from 0 to 12 with higher scores reflecting better acquisition.

  3. Controlled Oral Word Association Test (COWAT) at Last Infusion

    Time frame: visit 17

    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.

  4. Responder Rate on HAMD-17 by Last Infusion

    Time frame: visit 17

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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 13, 2015
Registry last updated
Aug 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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