Clinical trial NCT02522377: Administration of Subanesthetic Dose of Ketamine and Electroconvulsive Treatment for Treatment Resistant Depression
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment Resistant Depression
Major Depressive Disorder
Severe Depression
Keywords: Ketamine
Electroconvulsive Therapy
Major Depressive Disorder
Treatment Resistant Depression
electroconvulsive treatment
Severe depression
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Hamilton Depression Rating Scale (HAMD-17) at Last Infusion
timeFrame: visit 17
measure: Montgomery Asberg Depression Rating Scale (MADRS) at Last Infusion
timeFrame: visit 17
Secondary outcomes:
measure: Montreal Cognitive Assessment (MOCA) at Last Infusion
timeFrame: visit 17
measure: Hopkins Verbal Learning Test - Revised (HVLT-R) at Last Infusion
timeFrame: visit 17
measure: Controlled Oral Word Association Test (COWAT) at Last Infusion
timeFrame: visit 17
measure: Responder Rate on HAMD-17 by Last Infusion
timeFrame: visit 17
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation Center for Behavioral Health
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Murat Altinay, MD
role: PRINCIPAL_INVESTIGATOR
References: