CompletedNot Applicable

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

United States15 participantsStarted 2015-08

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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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.

What they're measuring

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

Timeframe: visit 17

Montgomery Asberg Depression Rating Scale (MADRS) at Last Infusion

Timeframe: visit 17

Trial details

NCT IDNCT02522377

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-03-01

Results submitted2019-06-27

View on ClinicalTrials.gov More Treatment Resistant Depression trials