Randomized Controlled Trial of Intranasal Ketamine vs. Intranasal Midazolam in Individuals With OCD

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Trial of Intranasal Ketamine vs. Intranasal Midazolam in Individuals With Obsessive Compulsive Disorder (OCD)

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Drug: Intranasal Ketamine
* Drug: Intranasal Midazolam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Midazolam<br>A single dose of intranasal midazolam up to 4 mg | Drug: Intranasal Midazolam<br>* A single dose of intranasal Midazolam up to 4 mg<br>|
| Experimental: Ketamine<br>A single dose of intranasal ketamine up to 50 mg | Drug: Intranasal Ketamine<br>* A single dose of intranasal ketamine up to 50 mg<br>* Other names: Ketamine Hydrochloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale. | Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS. | Baseline and 1 Week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCD