An interventional study of Ketamine and Midazolam in Treatment Resistant Depression, Major Depressive Disorder and Severe Depression, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-08-29.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment
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.
The study will compare the effects of standard ketamine dosing with an active placebo arm.
Hypothesis 1:
The investigators hypothesize that interleaved Electroconvulsive Treatment and active ketamine treatment will lead to a meaningful clinical improvement compared to Electroconvulsive Treatment and placebo treatment arm.
Hypothesis 2:
The investigators hypothesize that interleaved Electroconvulsive Treatment and active ketamine treatment will attenuate cognitive side effects.
Methods and Design:
Patients with treatment resistant depression who are deemed to be eligible for Electroconvulsive Treatment will randomly be assigned to either ketamine or active placebo
Electroconvulsive Treatments:
All patients (independent of their depression scores) will receive the same Electroconvulsive Treatment parameters: Bi-frontal brief pulse (0.5 miliseconds) Electroconvulsive Treatment administered by using Thymatron Electroconvulsive Treatment machine.
Study blinding:
Neither the patients, nor the treating psychiatrist or the nurse will be aware of the patient's assigned arm. The success of blinding will be tested after each ketamine treatment with a questionnaire given to the subject, raters, and treating physician.
472 studies on the registry are indexed under Depressive Disorder, Treatment-Resistant; 151 are open to participants now.
This study's enrollment of 15 is below the median of 51 across 397 interventional studies indexed under Depressive Disorder, Treatment-Resistant.
Browse Depressive Disorder, Treatment-Resistant studies →The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects who are randomized to be on this group will receive a standard dose of ketamine interleaved with Electroconvulsive Treatments.
Drug: Ketamine
Subjects who are randomized to be on this group will receive midazolam infusions interleaved with Electroconvulsive Treatments.
Drug: Midazolam
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.
Time frame: visit 17
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
Time frame: visit 17
Montreal Cognitive Assessment (MOCA) at Last Infusion
MoCA scores range between 0 and 30. Higher scores reflect higher cognition.
Time frame: visit 17
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.
Time frame: visit 17
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.
Time frame: visit 17
Responder Rate on HAMD-17 by Last Infusion
Count of the patients who showed response (\>50% decrease).
Time frame: visit 17
Patients with TRD who are admitted to the inpatient psychiatric to receive an acute series of ECT will randomly be assigned to one of the study arms.
| Milestone | Ketamine Infusions | Midazolam |
|---|---|---|
| Started | 7 | 5 |
| Completed | 3 | 5 |
| Not completed | 4 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Remission achieved | 3 | 0 |
Change in HAMD-17 at Infusion 6. Scores range from 0 to 50, with higher scores representing more depression.
| score on a scale | Ketamine Infusions | Midazolam |
|---|---|---|
| Hamilton Depression Rating Scale (HAMD-17) at Last Infusion | 13.74 ± 2.62 | 14.97 ± 2.85 |
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
| score on a scale | Ketamine Infusions | Midazolam |
|---|---|---|
| Montgomery Asberg Depression Rating Scale (MADRS) at Last Infusion | 22.29 ± 4.52 | 24.27 ± 5.93 |
MoCA scores range between 0 and 30. Higher scores reflect higher cognition.
| score on a scale | Ketamine Infusions | Midazolam |
|---|---|---|
| Montreal Cognitive Assessment (MOCA) at Last Infusion | 24.81 ± 0.96 | 25.79 ± 0.97 |
The number of words remembered are recorded. Scores range from 0 to 12 with higher scores reflecting better acquisition.
| score on a scale | Ketamine Infusions | Midazolam |
|---|---|---|
| Hopkins Verbal Learning Test - Revised (HVLT-R) at Last Infusion | 9.42 ± 0.56 | 11.20 ± 0.56 |
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.
| number of words | Ketamine Infusions | Midazolam |
|---|---|---|
| Controlled Oral Word Association Test (COWAT) at Last Infusion | 33.45 ± 2.83 | 37.17 ± 3.03 |
Count of the patients who showed response (\>50% decrease).
| Participants | Ketamine Infusions | Midazolam |
|---|---|---|
| No Response | 4 | 4 |
| Response | 3 | 1 |
Collected over 3 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ketamine Infusions | 0/7 (0%) | 0/7 (0%) | 1/7 (14.3%) |
| Midazolam | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Event | Ketamine Infusions | Midazolam |
|---|---|---|
| Suicidal ThoughtsPsychiatric disorders | 1/7 | 0/5 |
| Age, Categorical(Participants) | Ketamine Infusions | Midazolam | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 5 | 12 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Ketamine Infusions | Midazolam | Total |
|---|---|---|---|
| Mean | 39.1 ± 11.9 | 37.6 ± 15.5 | 38.5 ± 12.9 |
| Sex: Female, Male(Participants) | Ketamine Infusions | Midazolam | Total |
|---|---|---|---|
| Female | 6 | 4 | 10 |
| Male | 1 | 1 | 2 |
| Race/Ethnicity, Customized(Participants) | Ketamine Infusions | Midazolam | Total |
|---|---|---|---|
| Race — Caucasian | 5 | 4 | 9 |
| Race — Other | 2 | 1 | 3 |
| Region of Enrollment(participants) | Ketamine Infusions | Midazolam | Total |
|---|---|---|---|
| United States | 7 | 5 | 12 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
The record gives a start of Aug 2015, a primary completion of Mar 2018 and a completion of Mar 2018. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2019, 1 year 5 months after primary completion.
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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ketamine
Depressive Disorder, Treatment-Resistant →