Administration of Subanesthetic Dose of Ketamine and Electroconvulsive Treatment for Treatment Resistant Depression
Completed · Not applicable
Conditions studied: Treatment Resistant Depression, Major Depressive Disorder, Severe Depression
In brief
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.
Key facts
- Study ID
- NCT02522377
- Run by
- The Cleveland Clinic
- People needed
- 15
- Starts
- 2015-08-01
- Expected to finish
- 2018-03-01
- Last updated by the study team
- 2019-08-29
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Cleveland Clinic Foundation Center for Behavioral Health — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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