Understanding How Ketamine Brings About Rapid Improvement in OCD (MKET)

March 7, 2023 updated by: Carolyn Rodriguez, Stanford University

NMDAR Modulation As a Therapeutic Target and Probe of Neural Dysfunction in OCD

The purpose of this study is to understand how ketamine brings about rapid improvement in Obsessive-Compulsive Disorder (OCD) symptoms.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Obsessive-Compulsive Disorder (OCD) is a chronic and disabling disorder that costs the economy over $2 billion annually and represents a significant public health problem. This study aims to build on our discovery that a potent NMDA receptor antagonist, ketamine, has rapid (in hours) and robust therapeutic effects in OCD. The proposed projects test the acute mechanism of action of ketamine at the level of molecules, circuits, and network synchrony to determine how NMDA receptor antagonism modifies the underlying pathology of OCD to relieve repetitive thoughts and behaviors.

Study Type

Interventional

Enrollment (Anticipated)

120

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
    • California
      • Stanford, California, United States, 94305
        • Stanford University

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria for participants with OCD:

  • age 18-65
  • Primary diagnosis of OCD
  • Sufficient severity of OCD symptoms
  • ability to tolerate a treatment-free period
  • capacity to provide informed consent

Inclusion criteria for healthy controls:

  • ages 18-65
  • capacity to provide informed consent

Exclusion criteria for participants with OCD:

  • Psychiatric or medical conditions that make participation unsafe
  • pregnant or nursing females
  • concurrent use of any medications that might increase the risk of participation (e.g. drug interactions)
  • presence of metallic device or dental braces

Exclusion criteria for healthy controls:

  • any current or lifetime psychiatric diagnosis
  • pregnant or nursing females
  • major medical or neurological problem
  • presence of metallic device or dental braces

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketamine
OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion
Drug: Ketamine
OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion
Other Names:
  • Ketamine Hydrochloride
Active Comparator: Midazolam
OCD patients in this arm will receive 0.045mg/kg of midazolam - one single infusion
Drug: Midazolam
OCD patients in this arm will receive 0.045mg/kg of midazolam - one single infusion
Other Names:
  • Midazolam Hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improvement in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
Time Frame: Up to 6 months
Improvement in OCD severity is measured by the 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 is defined as at least a 35% reduction on the YBOCS.
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Regional gamma-aminobutyric acid, glutamate/glutamine levels derived from 3T Magnetic Resonance Spectroscopy
Time Frame: up to 90 minutes
up to 90 minutes

Collaborators and Investigators

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

Sponsor

Stanford University

Collaborators

University of Connecticut

Investigators

  • Principal Investigator: Carolyn I Rodriguez, MD, PhD, Stanford University

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.

General Publications

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

June 1, 2016

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

December 2, 2015

First Submitted That Met QC Criteria

December 7, 2015

First Posted (Estimate)

December 8, 2015

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

March 7, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 34622

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 [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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