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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02522377
• Other study ID #: Ketamine ECT
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: March 1, 2018

Study information

• Verified date: August 2019
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Major Depressive Disorder
• Severe Depression
• Treatment Resistant Depression

Intervention

Drug:
• Ketamine
inter venous injections
• Midazolam
inter venous injections

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation Center for Behavioral Health	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale (HAMD-17) at Last Infusion	Change in HAMD-17 at Infusion 6. Scores range from 0 to 50, with higher scores representing more depression.	visit 17
Primary	Montgomery Asberg Depression Rating Scale (MADRS) at Last Infusion	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	visit 17
Secondary	Montreal Cognitive Assessment (MOCA) at Last Infusion	MoCA scores range between 0 and 30. Higher scores reflect higher cognition.	visit 17
Secondary	Hopkins Verbal Learning Test - Revised (HVLT-R) at Last Infusion	The number of words remembered are recorded. Scores range from 0 to 12 with higher scores reflecting better acquisition.	visit 17
Secondary	Controlled Oral Word Association Test (COWAT) at Last Infusion	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.	visit 17
Secondary	Responder Rate on HAMD-17 by Last Infusion	Count of the patients who showed response (>50% decrease).	visit 17