Trial Outcomes & Findings for Administration of Subanesthetic Dose of Ketamine and Electroconvulsive Treatment for Treatment Resistant Depression (NCT NCT02522377)
NCT ID: NCT02522377
Last Updated: 2019-08-29
Results Overview
Change in HAMD-17 at Infusion 6. Scores range from 0 to 50, with higher scores representing more depression.
COMPLETED
NA
15 participants
visit 17
2019-08-29
Participant Flow
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.
15 patients with TRD, who were referred to the Cleveland Clinic outpatient depression clinic or ECT service, were recruited in the study. 3 subjects were lost prior to randomization. 2 subjects were lost to follow up after the screening visit, and 1 subject withdrew consent after the baseline visit.12 patients were included in the final analysis.
Participant milestones
| Measure |
Ketamine Infusions
Subjects who are randomized to be on this group will receive a standard dose of ketamine alternated with Electroconvulsive Treatments.
Ketamine: intervenous injections
|
Midazolam
Subjects who are randomized to be on this group will receive midazolam infusions interleaved with Electroconvulsive Treatments.
Midazolam: intervenous injections
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
5
|
|
Overall Study
COMPLETED
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Ketamine Infusions
Subjects who are randomized to be on this group will receive a standard dose of ketamine alternated with Electroconvulsive Treatments.
Ketamine: intervenous injections
|
Midazolam
Subjects who are randomized to be on this group will receive midazolam infusions interleaved with Electroconvulsive Treatments.
Midazolam: intervenous injections
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Remission Achieved
|
3
|
0
|
Baseline Characteristics
Administration of Subanesthetic Dose of Ketamine and Electroconvulsive Treatment for Treatment Resistant Depression
Baseline characteristics by cohort
| Measure |
Ketamine Infusions
n=7 Participants
Subjects who are randomized to be on this group will receive a standard dose of ketamine interleaved with Electroconvulsive Treatments.
Ketamine: intervenous injections
|
Midazolam
n=5 Participants
Subjects who are randomized to be on this group will receive midazolam infusions interleaved with Electroconvulsive Treatments.
Midazolam: intervenous injections
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
39.1 years
STANDARD_DEVIATION 11.9 • n=39 Participants
|
37.6 years
STANDARD_DEVIATION 15.5 • n=41 Participants
|
38.5 years
STANDARD_DEVIATION 12.9 • n=35 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
5 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=39 Participants
|
5 participants
n=41 Participants
|
12 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: visit 17Population: Analysis was performed on all patients using a mixed effect model. Maximum likelihood estimation allowed for inclusion of all patients, even when loss to follow-up or remission occurred.
Change in HAMD-17 at Infusion 6. Scores range from 0 to 50, with higher scores representing more depression.
Outcome measures
| Measure |
Ketamine Infusions
n=7 Participants
Subjects who are randomized to be on this group will receive a standard dose of ketamine alternated with Electroconvulsive Treatments.
Ketamine: intervenous injections
|
Midazolam
n=5 Participants
Subjects who are randomized to be on this group will receive midazolam infusions interleaved with Electroconvulsive Treatments.
Midazolam: intervenous injections
|
|---|---|---|
|
Hamilton Depression Rating Scale (HAMD-17) at Last Infusion
|
13.74 score on a scale
Standard Error 2.62
|
14.97 score on a scale
Standard Error 2.85
|
PRIMARY outcome
Timeframe: visit 17Population: Analysis was performed using mixed effect models. Maximum likelihood estimation allowed inclusion of all patients in analysis.
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
Outcome measures
| Measure |
Ketamine Infusions
n=7 Participants
Subjects who are randomized to be on this group will receive a standard dose of ketamine alternated with Electroconvulsive Treatments.
Ketamine: intervenous injections
|
Midazolam
n=5 Participants
Subjects who are randomized to be on this group will receive midazolam infusions interleaved with Electroconvulsive Treatments.
Midazolam: intervenous injections
|
|---|---|---|
|
Montgomery Asberg Depression Rating Scale (MADRS) at Last Infusion
|
22.29 score on a scale
Standard Error 4.52
|
24.27 score on a scale
Standard Error 5.93
|
SECONDARY outcome
Timeframe: visit 17Population: Analysis was performed on all patients using a mixed effect model. Maximum likelihood estimation allowed for inclusion of all patients, even when loss to follow-up or remission occurred.
MoCA scores range between 0 and 30. Higher scores reflect higher cognition.
Outcome measures
| Measure |
Ketamine Infusions
n=7 Participants
Subjects who are randomized to be on this group will receive a standard dose of ketamine alternated with Electroconvulsive Treatments.
Ketamine: intervenous injections
|
Midazolam
n=5 Participants
Subjects who are randomized to be on this group will receive midazolam infusions interleaved with Electroconvulsive Treatments.
Midazolam: intervenous injections
|
|---|---|---|
|
Montreal Cognitive Assessment (MOCA) at Last Infusion
|
24.81 score on a scale
Standard Error 0.96
|
25.79 score on a scale
Standard Error 0.97
|
SECONDARY outcome
Timeframe: visit 17Population: Analysis was performed on all patients using a mixed effect model. Maximum likelihood estimation allowed for inclusion of all patients, even when loss to follow-up or remission occurred.
The number of words remembered are recorded. Scores range from 0 to 12 with higher scores reflecting better acquisition.
Outcome measures
| Measure |
Ketamine Infusions
n=7 Participants
Subjects who are randomized to be on this group will receive a standard dose of ketamine alternated with Electroconvulsive Treatments.
Ketamine: intervenous injections
|
Midazolam
n=5 Participants
Subjects who are randomized to be on this group will receive midazolam infusions interleaved with Electroconvulsive Treatments.
Midazolam: intervenous injections
|
|---|---|---|
|
Hopkins Verbal Learning Test - Revised (HVLT-R) at Last Infusion
|
9.42 score on a scale
Standard Error 0.56
|
11.20 score on a scale
Standard Error 0.56
|
SECONDARY outcome
Timeframe: visit 17Population: Analysis was performed on all patients using a mixed effect model. Maximum likelihood estimation allowed for inclusion of all patients, even when loss to follow-up or remission occurred.
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.
Outcome measures
| Measure |
Ketamine Infusions
n=7 Participants
Subjects who are randomized to be on this group will receive a standard dose of ketamine alternated with Electroconvulsive Treatments.
Ketamine: intervenous injections
|
Midazolam
n=5 Participants
Subjects who are randomized to be on this group will receive midazolam infusions interleaved with Electroconvulsive Treatments.
Midazolam: intervenous injections
|
|---|---|---|
|
Controlled Oral Word Association Test (COWAT) at Last Infusion
|
33.45 number of words
Standard Error 2.83
|
37.17 number of words
Standard Error 3.03
|
SECONDARY outcome
Timeframe: visit 17Count of the patients who showed response (\>50% decrease).
Outcome measures
| Measure |
Ketamine Infusions
n=7 Participants
Subjects who are randomized to be on this group will receive a standard dose of ketamine alternated with Electroconvulsive Treatments.
Ketamine: intervenous injections
|
Midazolam
n=5 Participants
Subjects who are randomized to be on this group will receive midazolam infusions interleaved with Electroconvulsive Treatments.
Midazolam: intervenous injections
|
|---|---|---|
|
Responder Rate on HAMD-17 by Last Infusion
No Response
|
4 Participants
|
4 Participants
|
|
Responder Rate on HAMD-17 by Last Infusion
Response
|
3 Participants
|
1 Participants
|
Adverse Events
Ketamine Infusions
Midazolam
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ketamine Infusions
n=7 participants at risk
Subjects who are randomized to be on this group will receive a standard dose of ketamine alternated with Electroconvulsive Treatments.
Ketamine: intervenous injections
|
Midazolam
n=5 participants at risk
Subjects who are randomized to be on this group will receive midazolam infusions interleaved with Electroconvulsive Treatments.
Midazolam: intervenous injections
|
|---|---|---|
|
Psychiatric disorders
Suicidal Thoughts
|
14.3%
1/7 • Number of events 1 • 3 weeks
|
0.00%
0/5 • 3 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place