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

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02206776
• Other study ID #: #6952
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 31, 2014
• Last updated: November 8, 2016
• Start date: June 2014
• Est. completion date: June 2017

Study information

• Verified date: November 2016
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Disease
• Obsessive-Compulsive Disorder

Intervention

Drug:
• Intranasal Ketamine
A single dose of intranasal ketamine up to 50 mg
• Intranasal Midazolam
A single dose of intranasal Midazolam up to 4 mg

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in severity of Obsessive Compulsive Disorder symptoms as measured by the Yale-Brown Obsessive Compulsive Scale		3 Weeks	No
Primary	Improvement in severity of Obsessive Compulsive symptoms as measured by the Visual Analog Scale		3 Weeks	No

External Links

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