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

March 30, 2017 updated by: New York State Psychiatric Institute

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Midazolam
A single dose of intranasal midazolam up to 4 mg
Drug: Intranasal Midazolam
A single dose of intranasal Midazolam up to 4 mg
Experimental: Ketamine
A single dose of intranasal ketamine up to 50 mg
Drug: Intranasal Ketamine
A single dose of intranasal ketamine up to 50 mg
Other Names:
  • Ketamine Hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.
Time Frame: Baseline and 1 Week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

July 31, 2014

First Submitted That Met QC Criteria

July 31, 2014

First Posted (Estimate)

August 1, 2014

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

March 30, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #6952

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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