Administration of Subanesthetic Dose of Ketamine... — Clinical Trial Details

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.

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.

Company

Product

Legal

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

Detailed Description

Study Arms & Interventions

Ketamine

Interventions

Midazolam

Interventions

Locations

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators