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Understanding How Ketamine Brings About Rapid Improvement in OCD

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02624596
Acronym
MKET
Enrollment
120
Registered
2015-12-08
Start date
2016-08-16
Completion date
2021-06-28
Last updated
2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive-Compulsive Disorder

Keywords

OCD

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.

Interventions

DRUGKetamine

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

DRUGMidazolam

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

Sponsors

Stanford University
Lead SponsorOTHER
University of Connecticut
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
improvement in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)Up to 6 monthsImprovement 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

MeasureTime frame
Regional gamma-aminobutyric acid, glutamate/glutamine levels derived from 3T Magnetic Resonance Spectroscopyup to 90 minutes

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORCarolyn I Rodriguez, MD, PhD

Stanford University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 14, 2026