N/A
N=12
Administration of Subanesthetic Dose of Ketamine and Electroconvulsive Treatment for Treatment Resistant Depression
Treatment Resistant Depression · Major Depressive Disorder · Severe Depression
Bottom Line
View on ClinicalTrials.gov: NCT02522377 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Hamilton Depression Rating Scale (HAMD-17) at Last Infusion — 13.74; 14.97 score on a scale — p=0.72
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ketamine (Drug); Midazolam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hamilton Depression Rating Scale (HAMD-17) at Last Infusion |
13.74; 14.97 | 0.72 |
| PRIMARY Montgomery Asberg Depression Rating Scale (MADRS) at Last Infusion |
22.29; 24.27 | 0.77 |
| SECONDARY Montreal Cognitive Assessment (MOCA) at Last Infusion |
24.81; 25.79 | 0.40 |
| SECONDARY Hopkins Verbal Learning Test - Revised (HVLT-R) at Last Infusion |
9.42; 11.20 | 0.009 sig |
| SECONDARY Controlled Oral Word Association Test (COWAT) at Last Infusion |
33.45; 37.17 | 0.34 |
| SECONDARY Responder Rate on HAMD-17 by Last Infusion |
4; 4; 3; 1 | 0.58 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02522377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.