Intravenous Ketamine in the Treatment of Obsessive-Compulsive Disorder
Obsessive-Compulsive Disorder (OCD) is a chronic and disabling anxiety disorder and a leading cause of worldwide disability that presents a significant public health problem. Treatment options are limited and many OCD patients fail to respond completely or quickly to standard treatments, including pharmacotherapy and psychotherapy. At this time, patients who fail to respond to treatment with serotonergic drugs, augmenting antipsychotic agents, and behavioral therapy, have few additional treatment options aside from deep brain stimulation. Therefore, despite advances in current pharmacological and behavioral treatments, and the utility of serotonergic drugs, it is likely that other neurotransmitter systems are involved and that targeting these systems may increase treatment efficacy. Despite little evidence for serotonergic dysfunction in OCD, there is significant evidence that glutamatergic dysregulation may contribute to the development and progression of the disorder. Also, preliminary studies suggest that glutamatergic modulators (i.e. riluzole and d-cycloserine), particularly agents acting at the NMDA receptor (i.e. memantine), may be useful in OCD. The NMDA antagonist, ketamine, has demonstrated rapid effects when delivered as a single intravenous (IV) dose in depressed patients. Therefore, the objective of the current study is to investigate the safety and efficacy of a single dose of IV ketamine in treatment-resistant OCD.
Obsessive Compulsive Disorder
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Intravenous Ketamine in the Treatment of Obsessive-Compulsive Disorder|
- Change in Y-BOCCS from baseline to 24-hours after ketamine administration [ Time Frame: Baseline and 24 Hours ] [ Designated as safety issue: No ]The primary efficacy outcome is change in the Y-BOCCS from baseline to 24 hrs post-administration of ketamine.
- Percentage of patients who meet response and remission [ Time Frame: up to 14 days ] [ Designated as safety issue: No ]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.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
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.
This study will test the safety and efficacy of a single intravenous (IV) dose of the N-methyl-D-aspartate (NMDA) glutamate receptor antagonist, ketamine, in treatment-resistant OCD.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01371110
|Contact: Wayne K Goodman, MDfirstname.lastname@example.org|
|Contact: Kyle Lapidus, MDemail@example.com|
|United States, New York|
|Clinical Research Centers at Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 10029|
|Principal Investigator: Wayne K Goodman, MD|
|Principal Investigator: Kyle Lapidus, MD|
|Principal Investigator:||Wayne K Goodman, MD||Mount Sinai School of Medicine|
|Principal Investigator:||Kyle Lapidus, MD||Mount Sinai School of Medicine|