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

New York State Psychiatric Institute

Status and phase: Terminated; Phase 2

Conditions: Obsessive-Compulsive Disorder

Treatments: Drug: Intranasal Midazolam; Drug: Intranasal Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT02206776

#6952

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2 participants in 2 patient groups, including a placebo group

Midazolam

Placebo Comparator group

Description:

A single dose of intranasal midazolam up to 4 mg

Treatment:

Drug: Intranasal Midazolam

Ketamine

Experimental group

Description:

A single dose of intranasal ketamine up to 50 mg

Treatment:

Drug: Intranasal Ketamine