Understanding How Ketamine Brings About Rapid Improvement in OCD

Obsessive-Compulsive Disorder Clinical Trial

— MKET  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02624596
• Other study ID #: 34622
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 2016
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Drug:
• Ketamine
OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion
• Midazolam
OCD patients in this arm will receive 0.045mg/kg of midazolam - one single infusion

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	University of Connecticut

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 6 months
Secondary	Regional gamma-aminobutyric acid, glutamate/glutamine levels derived from 3T Magnetic Resonance Spectroscopy		up to 90 minutes

External Links

•   Rodriguez Lab Website
•   Stanford Medicine Faculty Page