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

Primary Purpose

Obsessive-Compulsive Disorder

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Midazolam
Sponsored by
Stanford University
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 - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ketamine

Midazolam

Arm Description

OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion

OCD patients in this arm will receive 0.045mg/kg of midazolam - one single infusion

Outcomes

Primary Outcome Measures

improvement in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
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.

Secondary Outcome Measures

Regional gamma-aminobutyric acid, glutamate/glutamine levels derived from 3T Magnetic Resonance Spectroscopy

Full Information

First Posted
December 2, 2015
Last Updated
March 7, 2023
Sponsor
Stanford University
Collaborators
University of Connecticut
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1. Study Identification

Unique Protocol Identification Number
NCT02624596
Brief Title
Understanding How Ketamine Brings About Rapid Improvement in OCD
Acronym
MKET
Official Title
NMDAR Modulation As a Therapeutic Target and Probe of Neural Dysfunction in OCD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
University of Connecticut

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketamine
Arm Type
Experimental
Arm Description
OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion
Arm Title
Midazolam
Arm Type
Active Comparator
Arm Description
OCD patients in this arm will receive 0.045mg/kg of midazolam - one single infusion
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketamine Hydrochloride
Intervention Description
OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Midazolam Hydrochloride
Intervention Description
OCD patients in this arm will receive 0.045mg/kg of midazolam - one single infusion
Primary Outcome Measure Information:
Title
improvement in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
Description
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.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Regional gamma-aminobutyric acid, glutamate/glutamine levels derived from 3T Magnetic Resonance Spectroscopy
Time Frame
up to 90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn I Rodriguez, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35267254
Citation
Bandeira ID, Lins-Silva DH, Cavenaghi VB, Dorea-Bandeira I, Faria-Guimaraes D, Barouh JL, Jesus-Nunes AP, Beanes G, Souza LS, Leal GC, Sanacora G, Miguel EC, Sampaio AS, Quarantini LC. Ketamine in the Treatment of Obsessive-Compulsive Disorder: A Systematic Review. Harv Rev Psychiatry. 2022 Mar-Apr 01;30(2):135-145. doi: 10.1097/HRP.0000000000000330.
Results Reference
derived
Links:
URL
https://med.stanford.edu/profiles/carolyn-rodriguez?tab=bio
Description
Stanford Medicine Faculty Page

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Understanding How Ketamine Brings About Rapid Improvement in OCD

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