Major Depressive Disorder Clinical Trial
Official title:
Administration of Subanesthetic Dose of Ketamine and Electroconvulsive Treatment on Alternate Week Days in Patients With Treatment Resistant Depression: A Double Blind Placebo Controlled Trial
NCT number | NCT02522377 |
Other study ID # | Ketamine ECT |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2015 |
Est. completion date | March 1, 2018 |
Verified date | August 2019 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | March 1, 2018 |
Est. primary completion date | March 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Foundation Center for Behavioral Health | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hamilton Depression Rating Scale (HAMD-17) at Last Infusion | Change in HAMD-17 at Infusion 6. Scores range from 0 to 50, with higher scores representing more depression. | visit 17 | |
Primary | Montgomery Asberg Depression Rating Scale (MADRS) at Last Infusion | Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60 | visit 17 | |
Secondary | Montreal Cognitive Assessment (MOCA) at Last Infusion | MoCA scores range between 0 and 30. Higher scores reflect higher cognition. | visit 17 | |
Secondary | Hopkins Verbal Learning Test - Revised (HVLT-R) at Last Infusion | The number of words remembered are recorded. Scores range from 0 to 12 with higher scores reflecting better acquisition. | visit 17 | |
Secondary | Controlled Oral Word Association Test (COWAT) at Last Infusion | This is a verbal fluency measure. Outcome is the count of words that meet criteria within 1 minute, so the minimum is 0 and no fixed maximum exists. Higher scores reflect a better outcome. | visit 17 | |
Secondary | Responder Rate on HAMD-17 by Last Infusion | Count of the patients who showed response (>50% decrease). | visit 17 |
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