Trial Outcomes & Findings for Ketamine Infusion for Adolescent Depression and Anxiety (NCT NCT02579928)
NCT ID: NCT02579928
Last Updated: 2020-07-14
Results Overview
Depressive symptoms (measured by Montgomery-Asberg Depression Rating Scale, revised (MADRS) score) on 1 day after infusion, for the cohort of subjects enrolled in the MDD arm of this trial. 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. Usual cutoff points are: 0 to 6 - normal /symptom absent. 7 to 19 - mild depression. 20 to 34 - moderate depression. \>34 - severe depression.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
17 participants
Primary outcome timeframe
1 day after the infusion
Results posted on
2020-07-14
Participant Flow
Adolescents (aged 13 to 17 years old) were recruited via (1) physician referral or (2) via direct inquiries from families via ClinicalTrials.gov listing. Subjects were enrolled at the Yale Child Study Center (New Haven, CT) between May 2016 and September 2018.
Participants were to remain on stable dosing of their current medication regimen for the four weeks prior to the first infusion, and during the four-week trial itself. All participants underwent a physical examination, laboratory screening, and electrocardiography.
Participant milestones
| Measure |
Ketamine First Then Midazolam
Participants received a Ketamine infusion under blinded conditions, followed by a Midazolam infusion 14 days later. The subject were monitored continuously during both infusions, and every hour for three hours after the infusion and then followed clinically for two weeks.
Ketamine was infused at a dose of 0.5mg/kg over 40 minutes and midazolam was infused at a dose of 0.045mg/kg over 40 minutes on the Hospital Research Unit of YNHH.
|
Midazolam First Then Ketamine
Participants received a midazolam infusion under blinded conditions, followed by a ketamine infusion 14 days later. The subject were monitored continuously during both infusions, and every hour for three hours after the infusion and then followed clinically for two weeks.
Midazolam was infused at a dose of 0.045mg/kg over 40 minutes and ketamine was infused at a dose of 0.5mg/kg over 40 minutes on the Hospital Research Unit of YNHH.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
11
|
|
Overall Study
COMPLETED
|
5
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Ketamine First Then Midazolam
Participants received a Ketamine infusion under blinded conditions, followed by a Midazolam infusion 14 days later. The subject were monitored continuously during both infusions, and every hour for three hours after the infusion and then followed clinically for two weeks.
Ketamine was infused at a dose of 0.5mg/kg over 40 minutes and midazolam was infused at a dose of 0.045mg/kg over 40 minutes on the Hospital Research Unit of YNHH.
|
Midazolam First Then Ketamine
Participants received a midazolam infusion under blinded conditions, followed by a ketamine infusion 14 days later. The subject were monitored continuously during both infusions, and every hour for three hours after the infusion and then followed clinically for two weeks.
Midazolam was infused at a dose of 0.045mg/kg over 40 minutes and ketamine was infused at a dose of 0.5mg/kg over 40 minutes on the Hospital Research Unit of YNHH.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Ketamine Infusion for Adolescent Depression and Anxiety
Baseline characteristics by cohort
| Measure |
Received Ketamine in the First Infusion
n=6 Participants
Participants that were randomly assigned to receive a dose of 0.5 mg/kg of Ketamine to be administered Intravenously during 40 minutes in the Hospital Research Unit of YNHH. Participants were monitored continuously during the procedure, and every hour for three hours after the infusion.
|
Received Midazolam in the First Infusion
n=11 Participants
Participants that were assigned to receive a dose of 0.045mg/kg of Midazolam, administered Intravenously during 40 minutes in the Hospital Research Unit of YNHH. Participants were monitored continuously during the procedure, and every hour for three hours after the infusion
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
15.3 years
n=5 Participants
|
15.6 years
n=7 Participants
|
15.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 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
|
1 Participants
n=5 Participants
|
0 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
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline Score for the Montgomery-Asberg Depression Rating Scale sc ore
|
35.6 units on a scale
STANDARD_DEVIATION 7.1 • n=5 Participants
|
31.8 units on a scale
STANDARD_DEVIATION 10.2 • n=7 Participants
|
32.9 units on a scale
STANDARD_DEVIATION 9.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 day after the infusionPopulation: A total of 17 patients were randomized to receive either Ketamine or Midazolam in the first infusion, one participant in withdrew from the trail after the first infusion because of improvement in her depressive symptoms and did not receive the second infusion.
Depressive symptoms (measured by Montgomery-Asberg Depression Rating Scale, revised (MADRS) score) on 1 day after infusion, for the cohort of subjects enrolled in the MDD arm of this trial. 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. Usual cutoff points are: 0 to 6 - normal /symptom absent. 7 to 19 - mild depression. 20 to 34 - moderate depression. \>34 - severe depression.
Outcome measures
| Measure |
Ketamine
n=16 Participants
Participants were randomly be assigned to receive a dose of 0.5 mg/kg of Ketamine (administered intravenously over 40 minutes with a maximum total dose allowed in this study will be 50mg). The participants were monitored continuously during the procedure, and every hour for three hours after the infusion.
Followed up clinically for the next 2 weeks.
|
Midazolam
n=16 Participants
Participants were assigned to receive a dose of 0.045mg/kg of Midazolam (administered Intravenously over 40 minutes with a the maximum total dose allowed in this study of 4.5mg), The participants were monitored continuously during the procedure, and every hour for three hours after the infusion.They were followed clinically for two weeks.
|
|---|---|---|
|
Montgomery-Asberg Depression Rating Scale Score 1 Day After Infusion
|
15.44 units on a scale
Interval 10.51 to 20.37
|
24.13 units on a scale
Interval 18.21 to 30.04
|
Adverse Events
Ketamine
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Midazolam
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ketamine
n=17 participants at risk
Participants were randomly be assigned to receive a dose of 0.5 mg/kg of Ketamine (administered intravenously over 40 minutes with a maximum total dose allowed in this study will be 50mg).
Ketamine: A single dose of 0.5mg/kg of Ketamine will be administered Intravenously during 40 minutes in the Hospital Research Unit of YNHH. The subject will be monitored continuously during the procedure, and every hour for three hours after the infusion.
|
Midazolam
n=16 participants at risk
Participants were randomly assigned to receive a dose of 0.045mg/kg of Midazolam (administered Intravenously over 40 minutes with a the maximum total dose allowed in this study of 4.5mg),
Midazolam: A single dose of 0.045mg/kg of Midazolam will be administered intravenously during 40 minutes in the Hospital Research Unit of YNHH. The subject will be monitored continuously during the procedure, and every hour for three hours after the infusion.
|
|---|---|---|
|
Nervous system disorders
Feeling like I am in a dream
|
88.2%
15/17 • Number of events 15 • 1 hour after after infusion.
|
6.2%
1/16 • Number of events 1 • 1 hour after after infusion.
|
|
Nervous system disorders
Spaced out
|
82.4%
14/17 • Number of events 14 • 1 hour after after infusion.
|
81.2%
13/16 • Number of events 13 • 1 hour after after infusion.
|
|
Nervous system disorders
Disconnected from body
|
70.6%
12/17 • Number of events 12 • 1 hour after after infusion.
|
12.5%
2/16 • Number of events 2 • 1 hour after after infusion.
|
|
Nervous system disorders
Feeling like thigs are in slow motion
|
64.7%
11/17 • Number of events 11 • 1 hour after after infusion.
|
6.2%
1/16 • Number of events 1 • 1 hour after after infusion.
|
|
Nervous system disorders
Body parts feel large or small
|
64.7%
11/17 • Number of events 11 • 1 hour after after infusion.
|
0.00%
0/16 • 1 hour after after infusion.
|
|
Nervous system disorders
Time is moving quickly
|
64.7%
11/17 • Number of events 11 • 1 hour after after infusion.
|
6.2%
1/16 • Number of events 1 • 1 hour after after infusion.
|
|
Nervous system disorders
Feeling like you are in a movie or are a robot
|
52.9%
9/17 • Number of events 9 • 1 hour after after infusion.
|
6.2%
1/16 • Number of events 1 • 1 hour after after infusion.
|
|
Nervous system disorders
Objects appear different
|
52.9%
9/17 • Number of events 9 • 1 hour after after infusion.
|
0.00%
0/16 • 1 hour after after infusion.
|
|
Nervous system disorders
Sounds changed
|
52.9%
9/17 • Number of events 9 • 1 hour after after infusion.
|
0.00%
0/16 • 1 hour after after infusion.
|
|
Nervous system disorders
World appears in a fog
|
41.2%
7/17 • Number of events 7 • 1 hour after after infusion.
|
6.2%
1/16 • Number of events 1 • 1 hour after after infusion.
|
|
Nervous system disorders
Gaps in memory
|
41.2%
7/17 • Number of events 7 • 1 hour after after infusion.
|
18.8%
3/16 • Number of events 3 • 1 hour after after infusion.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place