Trial Outcomes & Findings for Intravenous Ketamine in the Treatment of Obsessive-Compulsive Disorder (NCT NCT01371110)
NCT ID: NCT01371110
Last Updated: 2018-01-18
Results Overview
The primary efficacy outcome is change in the Y-BOCCS rating score on a scale from baseline to 24 hrs post-administration of ketamine. The 10 Y-BOCCS items are each scored on a four-point scale from 0 = "no symptoms" to 4 = "extreme symptoms." The sum of the first five items is a severity index for obsessions. The sum of the last five an index for compulsions. A translation of total score into an approximate index of overall severity is: 0-7 - subclinical; 8-15 - mild; 16-23 - moderate; 24-31 - severe; 32-40 - extreme.
TERMINATED
PHASE1/PHASE2
3 participants
Baseline and 24 Hours
2018-01-18
Participant Flow
Subjects were recruited from the Mood and Anxiety Disorders Program (MAPs). In addition, referrals from clinicians in the Mount Sinai Medical Center, community clinics, and affiliated hospitals were also sought.
Eligible participants met treatment-resistant criteria if they failed to respond to ≥ 2 adequate pharmacotherapy trials with SRIs FDA approved medications for OCD with or without adjunctive antipsychotics, as well as cognitive behavioral therapy.
Participant milestones
| Measure |
Ketamine (Randomized Week 1, Cross Over Midazolam Week 3))
Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride
Ketamine: Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter.
|
Midazolam (Randomized Wk 1, Cross Over Ketamine Wk 3)
Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam
Midazolam: Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intravenous Ketamine in the Treatment of Obsessive-Compulsive Disorder
Baseline characteristics by cohort
| Measure |
Ketamine (Randomized Week 1, Cross Over Midazolam Week 3))
n=1 Participants
Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride
Ketamine: Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter.
|
Midazolam (Randomized Wk 1, Cross Over Ketamine Wk 3)
n=2 Participants
Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam
Midazolam: Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 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
|
49 years
n=5 Participants
|
48.5 years
n=7 Participants
|
48.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 HoursThe primary efficacy outcome is change in the Y-BOCCS rating score on a scale from baseline to 24 hrs post-administration of ketamine. The 10 Y-BOCCS items are each scored on a four-point scale from 0 = "no symptoms" to 4 = "extreme symptoms." The sum of the first five items is a severity index for obsessions. The sum of the last five an index for compulsions. A translation of total score into an approximate index of overall severity is: 0-7 - subclinical; 8-15 - mild; 16-23 - moderate; 24-31 - severe; 32-40 - extreme.
Outcome measures
| Measure |
Ketamine (Randomized Week 1, Cross Over Midazolam Week 3))
n=1 Participants
Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride
Ketamine: Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter.
|
Midazolam (Randomized Wk 1, Cross Over Ketamine Wk 3)
n=2 Participants
Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam
Midazolam: Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant.
|
|---|---|---|
|
Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCCS) Rating OCD Symptom Severity From Baseline to 24-hours After Ketamine Administration
|
-2.98 Units on a scale
Interval -2.98 to -2.98
|
-2.185 Units on a scale
Interval -14.98 to 10.61
|
SECONDARY outcome
Timeframe: up to 14 daysPercentage of patients who meet response (defined as 25% reduction in Y-BOCCS score) and remission (defined as Y-BOCS score ≤10) criteria at 24 hrs post-infusion and durability of efficacy up to two weeks after administration. Assessments will be performed 24, 48 and 72 hrs post-infusion and after 7, 10, and 14 days.
Outcome measures
| Measure |
Ketamine (Randomized Week 1, Cross Over Midazolam Week 3))
n=1 Participants
Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride
Ketamine: Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter.
|
Midazolam (Randomized Wk 1, Cross Over Ketamine Wk 3)
n=2 Participants
Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam
Midazolam: Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant.
|
|---|---|---|
|
Percentage of Patients Who Meet Response and Remission
|
0 percentage of participants
|
50 percentage of participants
|
Adverse Events
Ketamine
Midazolam
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ketamine
n=1 participants at risk
Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride
Ketamine: Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter.
|
Midazolam
n=2 participants at risk
Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam
Midazolam: Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant.
|
|---|---|---|
|
Psychiatric disorders
Suicidality
|
0.00%
0/1 • 4 weeks
|
50.0%
1/2 • Number of events 1 • 4 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1 • 4 weeks
|
50.0%
1/2 • Number of events 1 • 4 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • 4 weeks
|
50.0%
1/2 • Number of events 1 • 4 weeks
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • Number of events 1 • 4 weeks
|
0.00%
0/2 • 4 weeks
|
|
Psychiatric disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • 4 weeks
|
0.00%
0/2 • 4 weeks
|
Additional Information
Wayne Goodman
Baylor College of Medicine (previously Icahn School of Medicine at Mount Sinai)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place