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

Primary Purpose

Obsessive-Compulsive Disorder

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intranasal Ketamine
Intranasal Midazolam
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring OCD

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Midazolam

Ketamine

Arm Description

A single dose of intranasal midazolam up to 4 mg

A single dose of intranasal ketamine up to 50 mg

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 31, 2014
Last Updated
March 30, 2017
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02206776
Brief Title
Randomized Controlled Trial of Intranasal Ketamine vs. Intranasal Midazolam in Individuals With OCD
Official Title
Randomized Controlled Trial of Intranasal Ketamine vs. Intranasal Midazolam in Individuals With Obsessive Compulsive Disorder (OCD)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
poor tolerability and low enrollment rate
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
OCD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Midazolam
Arm Type
Placebo Comparator
Arm Description
A single dose of intranasal midazolam up to 4 mg
Arm Title
Ketamine
Arm Type
Experimental
Arm Description
A single dose of intranasal ketamine up to 50 mg
Intervention Type
Drug
Intervention Name(s)
Intranasal Ketamine
Other Intervention Name(s)
Ketamine Hydrochloride
Intervention Description
A single dose of intranasal ketamine up to 50 mg
Intervention Type
Drug
Intervention Name(s)
Intranasal Midazolam
Intervention Description
A single dose of intranasal Midazolam up to 4 mg
Primary Outcome Measure Information:
Title
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.
Description
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.
Time Frame
Baseline and 1 Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn I Rodriguez, M.D., Ph.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://columbia-ocd.org/
Description
Related Info

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

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