Intravenous Ketamine in the Treatment of Obsessive-Compulsive Disorder (IVKetamine)
|ClinicalTrials.gov Identifier: NCT01371110|
Recruitment Status : Terminated (no funding)
First Posted : June 10, 2011
Results First Posted : October 2, 2017
Last Update Posted : January 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obsessive Compulsive Disorder||Drug: Ketamine Drug: Midazolam||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Intravenous Ketamine in the Treatment of Obsessive-Compulsive Disorder|
|Study Start Date :||June 2012|
|Primary Completion Date :||June 2015|
|Study Completion Date :||June 2015|
Active Comparator: Ketamine
Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride
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.
Other Name: ketamine hydrochloride
Sham Comparator: Midazolam
Study participants will receive a one-time intravenous infusion of 0.045 mg/kg 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 [ Time Frame: Baseline and 24 Hours ]
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.
- Percentage of Patients Who Meet Response and Remission [ Time Frame: up to 14 days ]Percentage 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01371110
|United States, New York|
|Clinical Research Centers at Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Wayne K Goodman, MD||Baylor College of Medicine (previously Icahn School of Medicine at Mount Sinai)|
|Principal Investigator:||Kyle Lapidus, MD||(previously Icahn School of Medicine at Mount Sinai)|