Clinical TrialTreatment-Resistant Depression (TRD)KetaminePlaceboCompleted

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 Electroconvulsion Therapy days.

Target Enrollment
15 participants
Study Type
Phase NA interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomised, quadruple-blind, parallel-group proof-of-concept trial (n=15) comparing IV ketamine infusions versus midazolam, both interleaved with bi-frontal brief-pulse ECT, in patients with treatment-resistant depression.

Primary hypotheses are that ketamine+ECT will produce greater clinical improvement than midazolam+ECT and will attenuate cognitive side effects; outcomes include depression severity, cognitive assessments, and safety measures.

Study Arms & Interventions

Ketamine

experimental

Standard IV ketamine infusions interleaved with ECT

Interventions

  • Ketamine
    via IV• interleaved with ECT

    Intravenous ketamine infusions interleaved with bi-frontal brief-pulse ECT.

Midazolam

active comparator

Active comparator: midazolam infusions interleaved with ECT

Interventions

  • Placebo
    via IV• interleaved with ECT

    Midazolam intravenous infusions (active comparator).

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion 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

  • 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.

Study Details

Locations

Cleveland Clinic Foundation Center for Behavioral Health — Cleveland, Ohio, United States

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