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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-05-31

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.

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Detailed Description

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Conditions

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Obsessive-Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Midazolam

A single dose of intranasal midazolam up to 4 mg

Group Type PLACEBO_COMPARATOR

Intranasal Midazolam

Intervention Type DRUG

A single dose of intranasal Midazolam up to 4 mg

Ketamine

A single dose of intranasal ketamine up to 50 mg

Group Type EXPERIMENTAL

Intranasal Ketamine

Intervention Type DRUG

A single dose of intranasal ketamine up to 50 mg

Interventions

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Intranasal Ketamine

A single dose of intranasal ketamine up to 50 mg

Intervention Type DRUG

Intranasal Midazolam

A single dose of intranasal Midazolam up to 4 mg

Intervention Type DRUG

Other Intervention Names

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Ketamine Hydrochloride

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No