Intravenous Ketamine in the Treatment of Obsessive-Compulsive Disorder (IVKetamine)
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|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|
|Actual Primary Completion Date :||June 2015|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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)|