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

NCT02522377 · The Cleveland Clinic

Closed to entry
Status
Not accepting participants
Not applicable
Phase
15
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

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

    Measured over visit 17

  • Montgomery Asberg Depression Rating Scale (MADRS) at Last Infusion

    Measured over visit 17

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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.

Where

1 study site

FacilityCityRegionCountry
Cleveland Clinic Foundation Center for Behavioral HealthClevelandOhioUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT02522377 on ClinicalTrials.gov →

Last updated in the registry 2019-08-29. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in