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Active, Not Recruiting

NCT Number: NCT02624596

Understanding How Ketamine Brings About Rapid Improvement in OCD

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

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

Other names: Ketamine Hydrochloride

midazolam

Drug

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

Other names: Midazolam Hydrochloride

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: up to 90 minutes

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • University of Connecticut

Registry information

Official study title

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

Acronym: MKET

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2015
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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