Trial Outcomes & Findings for Ketamine in the Treatment of Depression (NCT NCT01558063)
NCT ID: NCT01558063
Last Updated: 2019-12-10
Results Overview
The quantitative depressive symptom ratings were collected at Baseline, Day 1 (post ketamine), Day 3 using HDRS-24 (a 24-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery). The total score can range from 0 to a maximum score of 15 with a higher score indicating a worse outcome. A "responder" was defined as an individual exhibiting a reduction in the HDRS score from baseline to 24 hours (day 1) post-treatment, and all other individuals were classified as non-responders.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Day 1 (post ketamine)
Results posted on
2019-12-10
Participant Flow
Participant milestones
| Measure |
Ketamine Dose 1
0.1 mg/kg, IV (in the vein) of Ketamine and MRI scan
Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.
Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.
|
Ketamine Dose 2
0.2 mg/kg, IV (in the vein) of Ketamine and MRI scan
Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.
Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.
|
Ketamine Dose 3
0.3 mg/kg, IV (in the vein) of Ketamine and MRI scan
Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.
Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.
|
Ketamine Dose 4
0.4 mg/kg, IV (in the vein) of Ketamine and MRI scan
Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.
Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.
|
Ketamine Dose 5
0.5 mg/kg, IV (in the vein) of Ketamine and MRI scan
Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.
Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.
|
Saline Solution
Saline infused over 40 minutes and MRI scan
Saline: Single infusion of saline given intravenously over 40 minutes.
Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.
|
|---|---|---|---|---|---|---|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
STARTED
|
5
|
6
|
8
|
5
|
9
|
5
|
|
Overall Study
COMPLETED
|
5
|
6
|
8
|
5
|
9
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ketamine in the Treatment of Depression
Baseline characteristics by cohort
| Measure |
Ketamine Dose 1
n=5 Participants
0.1 mg/kg, IV (in the vein) of Ketamine and MRI scan
Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.
Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.
|
Ketamine Dose 2
n=6 Participants
0.2 mg/kg, IV (in the vein) of Ketamine and MRI scan
Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.
Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.
|
Ketamine Dose 3
n=8 Participants
0.3 mg/kg, IV (in the vein) of Ketamine and MRI scan
Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.
Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.
|
Ketamine Dose 4
n=5 Participants
0.4 mg/kg, IV (in the vein) of Ketamine and MRI scan
Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.
Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.
|
Ketamine Dose 5
n=9 Participants
0.5 mg/kg, IV (in the vein) of Ketamine and MRI scan
Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.
Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.
|
Saline Solution
n=5 Participants
Saline infused over 40 minutes and MRI scan
Saline: Single infusion of saline given intravenously over 40 minutes.
Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
37.4 years
STANDARD_DEVIATION 12.3 • n=93 Participants
|
37.8 years
STANDARD_DEVIATION 8.2 • n=4 Participants
|
38.1 years
STANDARD_DEVIATION 7.2 • n=27 Participants
|
30.6 years
STANDARD_DEVIATION 9.4 • n=483 Participants
|
40.2 years
STANDARD_DEVIATION 14.5 • n=36 Participants
|
46.8 years
STANDARD_DEVIATION 12.3 • n=10 Participants
|
38.46 years
STANDARD_DEVIATION 11.2 • n=115 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
25 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
32 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Day 1 (post ketamine)The quantitative depressive symptom ratings were collected at Baseline, Day 1 (post ketamine), Day 3 using HDRS-24 (a 24-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery). The total score can range from 0 to a maximum score of 15 with a higher score indicating a worse outcome. A "responder" was defined as an individual exhibiting a reduction in the HDRS score from baseline to 24 hours (day 1) post-treatment, and all other individuals were classified as non-responders.
Outcome measures
| Measure |
Ketamine Dose 1
n=5 Participants
0.1 mg/kg, IV (in the vein) of Ketamine and MRI scan
Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.
Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.
|
Ketamine Dose 2
n=6 Participants
0.2 mg/kg, IV (in the vein) of Ketamine and MRI scan
Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.
Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.
|
Ketamine Dose 3
n=8 Participants
0.3 mg/kg, IV (in the vein) of Ketamine and MRI scan
Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.
Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.
|
Ketamine Dose 4
n=5 Participants
0.4 mg/kg, IV (in the vein) of Ketamine and MRI scan
Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.
Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.
|
Ketamine Dose 5
n=9 Participants
0.5 mg/kg, IV (in the vein) of Ketamine and MRI scan
Ketamine: Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.
Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.
|
Saline Solution
n=5 Participants
Saline infused over 40 minutes and MRI scan
Saline: Single infusion of saline given intravenously over 40 minutes.
Magnetic Resonance Imaging (MRI): 90-minute scan during the 40-minute infusion.
|
|---|---|---|---|---|---|---|
|
Number of Responders 24-hours Post-ketamine Infusion
|
3 participants
|
1 participants
|
3 participants
|
2 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and 120 minutes after infusionPopulation: The data was not collected at 120 minutes and therefore was not analyzed for this outcome measure.
The dose-response curve as it refers to ketamine inducing a dose-dependent increase in glutamate levels with 1H Magnetic Resonance Spectroscopy (MRS) will be analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 120 minutes after infusionPopulation: This data was not collected and therefore was not analyzed.
The dose-response curve as it refers to ketamine inducing a dose-dependent increase in GABA levels measured with 1H Magnetic Resonance Spectroscopy (MRS) will be analyzed.
Outcome measures
Outcome data not reported
Adverse Events
All Subjects
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Subjects
n=38 participants at risk
Includes all subjects receiving either saline or ketamine. Safety data was not collected or analyzed per dose level of ketamine.
|
|---|---|
|
Psychiatric disorders
Active Suicidal Ideation
|
2.6%
1/38 • Number of events 1
|
|
Product Issues
Antidepressant Misuse
|
2.6%
1/38 • Number of events 1
|
|
General disorders
Unrelated Medical Illness
|
5.3%
2/38 • Number of events 2
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place