Trial Outcomes & Findings for Pilot Study of Ketamine in Adults With Obsessive-Compulsive Disorder (OCD) (NCT NCT01100255)
NCT ID: NCT01100255
Last Updated: 2017-02-20
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
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
1 week
Results posted on
2017-02-20
Participant Flow
Participant milestones
| Measure |
Group A
0.5mg/kg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes
|
Group B
IV saline infusion over 40 minutes then 0.5mg/kg IV ketamine infusion over 40 minutes
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
|
Overall Study
COMPLETED
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of Ketamine in Adults With Obsessive-Compulsive Disorder (OCD)
Baseline characteristics by cohort
| Measure |
Group A
n=8 Participants
0.5mg/kg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes
|
Group B
n=7 Participants
IV saline infusion over 40 minutes then 0.5mg/kg IV ketamine infusion over 40 minutes
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 10 • n=5 Participants
|
32 years
STANDARD_DEVIATION 8 • n=7 Participants
|
34 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Gender
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Gender
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 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
|
1 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
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 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: 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 |
Saline Infusion
n=15 Participants
IV saline infusion over 40 minutes
Saline: saline infusion
|
Ketamine Infusion
n=15 Participants
0.5mg/kg IV infusion over 40 minutes
Ketamine infusion: 0.5mg/kg IV over 40 minutes
|
|---|---|---|
|
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.
|
0 participants
|
5 participants
|
Adverse Events
Saline Infusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ketamine Infusion
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Saline Infusion
n=15 participants at risk
IV saline infusion over 40 minutes
|
Ketamine Infusion
n=15 participants at risk
0.5mg/kg IV ketamine infusion over 40 minutes
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/15
|
20.0%
3/15 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15
|
13.3%
2/15 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/15
|
13.3%
2/15 • Number of events 2
|
Additional Information
Dr. Carolyn Rodriguez, Assistant Professor
Stanford University
Phone: 6507236158
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place