Understanding How Ketamine Brings About Rapid Improvement in OCD

Phase 2

Active, not recruiting

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Drug: Ketamine; Drug: Midazolam

• Registration Number: NCT02624596
• Lead Sponsor: Stanford University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-12-02
• Study First Submitted QC: 2015-12-07
• Study First Posted: 2015-12-08
• Study Start: 2016-06
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-23
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine	Ketamine	OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion
Midazolam	Midazolam	OCD patients in this arm will receive 0.045mg/kg of midazolam - one single infusion

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Regional gamma-aminobutyric acid, glutamate/glutamine levels derived from 3T Magnetic Resonance Spectroscopy	up to 90 minutes

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States