This trial is active, not recruiting.

Condition obsessive-compulsive disorder
Treatments intranasal ketamine, intranasal midazolam
Phase phase 2
Sponsor New York State Psychiatric Institute
Start date June 2014
End date June 2016
Trial size 50 participants
Trial identifier NCT02206776, #6952


Obsessive-compulsive disorder (OCD) is a common illness that causes significant distress and impairment. Currently, serotonin reuptake inhibitors (SRIs) are the only medications that are FDA-approved to treat OCD. Unfortunately, SRIs can take a long time to work (2-3 months), and even then they usually only partially reduce OCD symptoms. The present study, will test if intranasal ketamine is feasible to use and can reduce OCD symptoms significantly more than a comparison medication called midazolam. Therefore, you may or may not receive ketamine as part of this study. Results from this study will allow doctors and researchers to better understand if you and others with OCD may respond to this class of medications.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
(Placebo Comparator)
A single dose of intranasal midazolam up to 4 mg
intranasal midazolam
A single dose of intranasal Midazolam up to 4 mg
A single dose of intranasal ketamine up to 50 mg
intranasal ketamine Ketamine Hydrochloride
A single dose of intranasal ketamine up to 50 mg

Primary Outcomes

Improvement in severity of Obsessive Compulsive Disorder symptoms as measured by the Yale-Brown Obsessive Compulsive Scale
time frame: 3 Weeks
Improvement in severity of Obsessive Compulsive symptoms as measured by the Visual Analog Scale
time frame: 3 Weeks

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - Age 18-55 - Physically healthy and not currently pregnant - Primary diagnosis of OCD - Sufficient severity of symptoms - For all patients on medications, medications dose must be stable for at least 6 weeks prior to enrollment. Must discuss with Dr. current medications and doses. - Able to provide consent Exclusion Criteria: - First degree relative with schizophrenia - Psychiatric conditions that would make participation unsafe determined by study doctor - Female patients who are either pregnant or nursing - Planning to start EX/RP during the period of the study or those who have completed an adequate dose of EX/RP (defined as 8 or more sessions within 2 months) within 8 weeks prior to enrollment. - Nasal obstruction or history of nasal surgery - Currently on psychotropic medication or other medication likely to interact with the glutamate system - Medical conditions that make participation unsafe - Allergy or intolerance to ketamine or midazolam

Additional Information

Official title Randomized Controlled Trial of Intranasal Ketamine vs. Intranasal Midazolam in Individuals With Obsessive Compulsive Disorder (OCD)
Principal investigator H Blair Simpson, M.D., Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by New York State Psychiatric Institute.