Trial Outcomes & Findings for Prevention of N-methyl-D-aspartate (NMDA) Antagonist-induced Psychosis in Kids (NCT NCT00205712)
NCT ID: NCT00205712
Last Updated: 2016-01-14
Results Overview
Participant received behavioral ratings before medication and during medication for the primary analysis comparison. This is an observer-scale with a value range from 0-6 (0=no symptoms 6=worst symptoms)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
Before Ketamine, During Ketamine
Results posted on
2016-01-14
Participant Flow
Participant milestones
| Measure |
Ketamine Alone
Ketamine without dexmedetomidine
|
Ketamine Plus Dexmedetomidine
Ketamine infusion plus dexmedetomidine
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Ketamine Alone
Ketamine without dexmedetomidine
|
Ketamine Plus Dexmedetomidine
Ketamine infusion plus dexmedetomidine
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Prevention of N-methyl-D-aspartate (NMDA) Antagonist-induced Psychosis in Kids
Baseline characteristics by cohort
| Measure |
Ketamine Alone
n=20 Participants
ketamine without dexmedetomidine
|
Ketamine Plus Dexmedetomidine
n=20 Participants
ketamine infusion plus dexmedetomidine
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 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
|
11.2 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
10.9 years
STANDARD_DEVIATION 2.4 • n=7 Participants
|
11 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Before Ketamine, During KetaminePopulation: Completers analysis per protocol. Two participants were missing some data at either the before ketamine or during ketamine time point.
Participant received behavioral ratings before medication and during medication for the primary analysis comparison. This is an observer-scale with a value range from 0-6 (0=no symptoms 6=worst symptoms)
Outcome measures
| Measure |
Ketamine Alone
n=20 Participants
ketamine without dexmedetomidine
|
Ketamine Plus Dexmedetomidine
n=18 Participants
ketamine infusion plus dexmedetomidine
|
|---|---|---|
|
Brief Psychiatric Ratings Scale (BPRS) Positive Symptom Subscale Score
BPRS Positive symptom subscale-before medication
|
0.00 Scale of 0-6
Standard Deviation 0.00
|
0.00 Scale of 0-6
Standard Deviation 0.00
|
|
Brief Psychiatric Ratings Scale (BPRS) Positive Symptom Subscale Score
BPRS Positive symptom subscale-during medication
|
1.40 Scale of 0-6
Standard Deviation 2.37
|
1.00 Scale of 0-6
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Before Ketamine, During Ketamine, Post Ketamine and 1 Week Follow upPopulation: Completers analysis per protocol. Two participants were missing some data at either the before ketamine or during ketamine time point.
Pain intensity was measured on a scale of 1-10 (1=lowest pain intensity, 10=highest pain intensity) in participants before medication, during medication, post medication and 1 week follow up.
Outcome measures
| Measure |
Ketamine Alone
n=18 Participants
ketamine without dexmedetomidine
|
Ketamine Plus Dexmedetomidine
n=18 Participants
ketamine infusion plus dexmedetomidine
|
|---|---|---|
|
Visual Analog Scale (VAS) Pain Intensity
VAS Pain-Before Medication
|
4.72 Scale of 1-10
Standard Deviation 1.93
|
4.03 Scale of 1-10
Standard Deviation 2.38
|
|
Visual Analog Scale (VAS) Pain Intensity
VAS Pain-Before Cognitive Testing
|
2.75 Scale of 1-10
Standard Deviation 1.65
|
2.89 Scale of 1-10
Standard Deviation 1.78
|
|
Visual Analog Scale (VAS) Pain Intensity
VAS Pain-After Cognitive Testing
|
2.61 Scale of 1-10
Standard Deviation 1.33
|
4.08 Scale of 1-10
Standard Deviation 1.85
|
|
Visual Analog Scale (VAS) Pain Intensity
VAS Pain-1 Week F/U
|
1.33 Scale of 1-10
Standard Deviation 0.59
|
1.76 Scale of 1-10
Standard Deviation 1.64
|
SECONDARY outcome
Timeframe: Before Ketamine, During Ketamine, Post Ketamine, 1 week follow upAnxiety was measured on a scale of 1-10 (1=lowest pain intensity, 10=highest pain intensity) in participants before medication, during medication, post medication and 1 week follow up.
Outcome measures
| Measure |
Ketamine Alone
n=20 Participants
ketamine without dexmedetomidine
|
Ketamine Plus Dexmedetomidine
n=18 Participants
ketamine infusion plus dexmedetomidine
|
|---|---|---|
|
Visual Analog Scale (VAS) Anxiety Rating
VAS Anxiety-Before Medication
|
5.0 Scale of 1-10
Standard Deviation 2.43
|
5.0 Scale of 1-10
Standard Deviation 2.35
|
|
Visual Analog Scale (VAS) Anxiety Rating
VAS Anxiety-Before Cogntive Testing
|
1.67 Scale of 1-10
Standard Deviation 0.97
|
2.53 Scale of 1-10
Standard Deviation 1.58
|
|
Visual Analog Scale (VAS) Anxiety Rating
VAS Anxiety-After Cognitive Testing
|
1.71 Scale of 1-10
Standard Deviation 1.14
|
3.00 Scale of 1-10
Standard Deviation 2.04
|
|
Visual Analog Scale (VAS) Anxiety Rating
VAS Anxiety-1 Week Follow Up
|
1.56 Scale of 1-10
Standard Deviation 1.20
|
2.06 Scale of 1-10
Standard Deviation 1.82
|
Adverse Events
Ketamine Alone
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Ketamine Plus Dexmedetomidine
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ketamine Alone
n=20 participants at risk
Ketamine without dexmedetomidine
|
Ketamine Plus Dexmedetomidine
n=20 participants at risk
Ketamine infusion with dexmedetomidine
|
|---|---|---|
|
Nervous system disorders
Sedation
|
95.0%
19/20 • Number of events 19
|
95.0%
19/20 • Number of events 19
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
25.0%
5/20 • Number of events 5
|
60.0%
12/20 • Number of events 12
|
|
Nervous system disorders
headache
|
15.0%
3/20 • Number of events 3
|
35.0%
7/20 • Number of events 7
|
|
Nervous system disorders
Dizziness
|
55.0%
11/20 • Number of events 11
|
55.0%
11/20 • Number of events 11
|
|
Nervous system disorders
Difficulty Walking
|
20.0%
4/20 • Number of events 4
|
20.0%
4/20 • Number of events 4
|
|
General disorders
Trouble Breathing
|
10.0%
2/20 • Number of events 2
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Visual Hallucinations
|
30.0%
6/20 • Number of events 6
|
30.0%
6/20 • Number of events 6
|
|
Nervous system disorders
Unpleasant Dreams
|
20.0%
4/20 • Number of events 4
|
10.0%
2/20 • Number of events 2
|
|
Nervous system disorders
Numbness
|
75.0%
15/20 • Number of events 15
|
60.0%
12/20 • Number of events 12
|
Additional Information
John Newcomer, MD
Washington University School of Medicine
Phone: 314-362-3153
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place