Trial Outcomes & Findings for Ketamine as an Augmentation Strategy for Electroconvulsive Therapy (ECT) in Depression (NCT NCT01881763)
NCT ID: NCT01881763
Last Updated: 2023-03-09
Results Overview
The items mostly range from a score of 0-4 but there are some questions that range from a score of 0-2. The maximum total score that can be reported is 76 and the lowest score is 0. Higher values represent a worse outcome. Items are summed together to compute the total score. Remission is defined as two consecutive Hamilton Rating Scale for Depression, 24 items (HRSD-24) scores \< 10, and HRSD-24 total score does not increase \> 3 points on the second consecutive HRSD-24, or remains \< 6 at the last two consecutive treatments. HRSD-24 scores are used to define remission.
COMPLETED
PHASE4
31 participants
Days required to achieve remission (on average 3-4 weeks)
2023-03-09
Participant Flow
Participant milestones
| Measure |
Ketamine
Participants will be randomized 1:1 to either Ketamine (experimental condition) or Methohexital anesthesia (active comparator)
Ketamine: Ketamine 1-2 mgr/ kg IV
|
Methohexital
Participants will be randomized 1:1 to either Ketamine (experimental condition) or Methohexital anesthesia (active comparator)
Methohexital: Methohexital 0.5-1mg/kg IV
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ketamine as an Augmentation Strategy for Electroconvulsive Therapy (ECT) in Depression
Baseline characteristics by cohort
| Measure |
Ketamine
n=16 Participants
Participants will be randomized 1:1 to either Ketamine (experimental condition) or Methohexital anesthesia (active comparator)
Ketamine: Ketamine 1-2 mgr/ kg IV
|
Methohexital
n=15 Participants
Participants will be randomized 1:1 to either Ketamine (experimental condition) or Methohexital anesthesia (active comparator)
Methohexital: Methohexital 0.5-1mg/kg IV
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.01 years
STANDARD_DEVIATION 15.04 • n=5 Participants
|
48.34 years
STANDARD_DEVIATION 9.27 • n=7 Participants
|
48.17 years
STANDARD_DEVIATION 12.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days required to achieve remission (on average 3-4 weeks)The items mostly range from a score of 0-4 but there are some questions that range from a score of 0-2. The maximum total score that can be reported is 76 and the lowest score is 0. Higher values represent a worse outcome. Items are summed together to compute the total score. Remission is defined as two consecutive Hamilton Rating Scale for Depression, 24 items (HRSD-24) scores \< 10, and HRSD-24 total score does not increase \> 3 points on the second consecutive HRSD-24, or remains \< 6 at the last two consecutive treatments. HRSD-24 scores are used to define remission.
Outcome measures
| Measure |
Ketamine
n=10 Participants
Participants will be randomized 1:1 to either Ketamine (experimental condition) or Methohexital anesthesia (active comparator)
Ketamine: Ketamine 1-2 mgr/ kg IV
|
Methohexital
n=11 Participants
Participants will be randomized 1:1 to either Ketamine (experimental condition) or Methohexital anesthesia (active comparator)
Methohexital: Methohexital 0.5-1mg/kg IV
|
|---|---|---|
|
Hamilton Rating Scale for Depression (HRSD) Improvement
|
7.82 HRSD units
Standard Deviation 3.43
|
8.60 HRSD units
Standard Deviation 3.72
|
SECONDARY outcome
Timeframe: Neuropsychological Battery: Changes from baseline to the end of the ECT course (on average 3-4 weeks)Population: Data was not collected and the outcome cannot be reported. A total of 0 participants were analyzed due to slower than anticipated recruitment for this study therefore, we were not able to recruit a sufficient number of subjects for statistical analysis prior to the end of the funding period.
To determine the cognitive side effects we will use the following neuropsychological battery: * Mini- Mental State Examination (MMSE), * Postictal Recovery of Orientation, * Rey Auditory Verbal Learning Test (RAVLT) * Autobiographical Memory Interview - Short Form (AMI - SF), * Subjective Memory Questionnaire (SMQ), * Reading subtest of the Wide Range Achievement Test, 3rd Edition (WRAT-3), * The Stroop Color Word Test (SCWT) (Golden version), * Trail Making Test Part A \& B, * Wechsler Adult Intelligence Test-Third Edition (WAIS-III), Digit Span Subtest, * WAIS-III Digit Symbol, * Controlled Oral Word Association Test (COWAT), * N-Back test
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Changes from baseline to the end of ECT course (approximately 3-4 weeks)Population: Data was not collected and the outcome cannot be reported. A total of 0 participants were analyzed due to slower than anticipated recruitment for this study therefore, we were not able to recruit a sufficient number of subjects for statistical analysis prior to the end of the funding period.
To use resting state and task related fMRI to identify ECT related functional network changes in the brain. Using resting state fMRI before and after ECT, we will (a) identify networks modulated by ECT (defined as a decrease or increase in functional connectivity from baseline to follow up scans), and we will (b) follow up their expression in the upcoming weeks, we will (c) identify functional networks of the brain which are correlated with superior clinical ECT outcome and we will (d) identify functional networks of the brain which are correlated with side effect profiles.
Outcome measures
Outcome data not reported
Adverse Events
Ketamine
Methohexital
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place