Trial Outcomes & Findings for N-methyl-D-aspartate Antagonist (Ketamine) Augmentation of Electroconvulsive Treatment for Severe Major Depression (NCT NCT01260649)
NCT ID: NCT01260649
Last Updated: 2017-05-22
Results Overview
HAMD will be administered at every ECT treatment.The HAM D 28 is a 28 item scale with scores ranging from 0 to 83, with 0 being no depression and 83 being high levels of depression symptoms. The change in HAM S score was determined by the difference of the HAM D score at the last ECT administration and the baseline HAM D score. A negative change score reflects a decreased HAM D score between the first and last ECT administration and therefore a reduction in depressive symptoms.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
17 participants
Primary outcome timeframe
baseline, one month
Results posted on
2017-05-22
Participant Flow
Participant milestones
| Measure |
Ketamine
ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week
ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care
|
Placebo
IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.
Right unilateral ECT at 5-6x seizure threshold three times a week
ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
|
Overall Study
COMPLETED
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
N-methyl-D-aspartate Antagonist (Ketamine) Augmentation of Electroconvulsive Treatment for Severe Major Depression
Baseline characteristics by cohort
| Measure |
Ketamine
n=6 Participants
ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week
ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care
|
Placebo
n=8 Participants
IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.
Right unilateral ECT at 5-6x seizure threshold three times a week
ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
41.43 years
STANDARD_DEVIATION 15.62 • n=5 Participants
|
48.75 years
STANDARD_DEVIATION 12.22 • n=7 Participants
|
48.57 years
STANDARD_DEVIATION 13.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, one monthHAMD will be administered at every ECT treatment.The HAM D 28 is a 28 item scale with scores ranging from 0 to 83, with 0 being no depression and 83 being high levels of depression symptoms. The change in HAM S score was determined by the difference of the HAM D score at the last ECT administration and the baseline HAM D score. A negative change score reflects a decreased HAM D score between the first and last ECT administration and therefore a reduction in depressive symptoms.
Outcome measures
| Measure |
Ketamine
n=6 Participants
ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week
ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care
|
Placebo
n=8 Participants
IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.
Right unilateral ECT at 5-6x seizure threshold three times a week
ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care
|
|---|---|---|
|
Change in Hamilton Depression Rating Scale - 28
|
-17.50 units on a scale
Standard Deviation 6.53
|
-14.00 units on a scale
Standard Deviation 14.20
|
SECONDARY outcome
Timeframe: 3 monthswill compare the incidence of participants with memory deficits between groups, as determined by incidents of clinician reported cognitive adverse events
Outcome measures
| Measure |
Ketamine
n=6 Participants
ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week
ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care
|
Placebo
n=8 Participants
IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.
Right unilateral ECT at 5-6x seizure threshold three times a week
ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care
|
|---|---|---|
|
Number of Participants With Cognitive Side Effects
|
0 Participants
|
1 Participants
|
Adverse Events
Ketamine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ketamine
n=6 participants at risk
ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week
ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care
|
Placebo
n=8 participants at risk
IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.
Right unilateral ECT at 5-6x seizure threshold three times a week
ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care
|
|---|---|---|
|
Psychiatric disorders
Racing Thoughts
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Body pain
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
Other adverse events
| Measure |
Ketamine
n=6 participants at risk
ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week
ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care
|
Placebo
n=8 participants at risk
IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.
Right unilateral ECT at 5-6x seizure threshold three times a week
ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care
|
|---|---|---|
|
Ear and labyrinth disorders
Fluid in right ear
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
|
Psychiatric disorders
Sedation
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Short term memory impairment
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
0.00%
0/6
|
12.5%
1/8 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Jaw pain
|
16.7%
1/6 • Number of events 1
|
0.00%
0/8
|
|
Hepatobiliary disorders
Increased Blood sugar
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Numbness in feet and body
|
16.7%
1/6 • Number of events 1
|
0.00%
0/8
|
|
Cardiac disorders
Heart pounding/tightness in chest
|
16.7%
1/6 • Number of events 1
|
0.00%
0/8
|
|
Nervous system disorders
Tingling in feet
|
16.7%
1/6 • Number of events 1
|
0.00%
0/8
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Number of events 1
|
0.00%
0/8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place