Trial Outcomes & Findings for Randomized Controlled Trial of Intranasal Ketamine vs. Intranasal Midazolam in Individuals With OCD (NCT NCT02206776)
NCT ID: NCT02206776
Last Updated: 2017-05-03
Results Overview
Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
Baseline and 1 Week
Results posted on
2017-05-03
Participant Flow
Participant milestones
| Measure |
Midazolam
A single dose of intranasal midazolam up to 4 mg
Intranasal Midazolam: A single dose of intranasal Midazolam up to 4 mg
|
Ketamine
A single dose of intranasal ketamine up to 50 mg
Intranasal Ketamine: A single dose of intranasal ketamine up to 50 mg
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Controlled Trial of Intranasal Ketamine vs. Intranasal Midazolam in Individuals With OCD
Baseline characteristics by cohort
| Measure |
Midazolam
n=1 Participants
A single dose of intranasal midazolam up to 4 mg
Intranasal Midazolam: A single dose of intranasal Midazolam up to 4 mg
|
Ketamine
n=1 Participants
A single dose of intranasal ketamine up to 50 mg
Intranasal Ketamine: A single dose of intranasal ketamine up to 50 mg
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20 years
STANDARD_DEVIATION 0 • n=5 Participants
|
36 years
STANDARD_DEVIATION 0 • n=7 Participants
|
28 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
PRIMARY outcome
Timeframe: Baseline and 1 WeekPatients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.
Outcome measures
| Measure |
Midazolam
n=1 Participants
A single dose of intranasal midazolam up to 4 mg
Intranasal Midazolam: A single dose of intranasal Midazolam up to 4 mg
|
Ketamine
n=1 Participants
A single dose of intranasal ketamine up to 50 mg
Intranasal Ketamine: A single dose of intranasal ketamine up to 50 mg
|
|---|---|---|
|
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.
|
0 Participants
|
0 Participants
|
Adverse Events
Midazolam
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Ketamine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Midazolam
n=1 participants at risk
A single dose of intranasal midazolam up to 4 mg
Intranasal Midazolam: A single dose of intranasal Midazolam up to 4 mg
|
Ketamine
n=1 participants at risk
A single dose of intranasal ketamine up to 50 mg
Intranasal Ketamine: A single dose of intranasal ketamine up to 50 mg
|
|---|---|---|
|
Psychiatric disorders
perceptual changes (e.g. feeling as if body changed in size)
|
100.0%
1/1 • Number of events 1
|
100.0%
1/1 • Number of events 1
|
|
Nervous system disorders
headache
|
100.0%
1/1 • Number of events 1
|
0.00%
0/1
|
|
Nervous system disorders
lighheadedness
|
100.0%
1/1 • Number of events 1
|
0.00%
0/1
|
Additional Information
Dr. Carolyn Rodriguez, Assistant Professor
Stanford University
Phone: 650-723-4095
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place