Understanding How Ketamine Brings About Rapid Improvement in OCD

Ketamine

Brief Summary

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

Intervention / Treatment

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

Condition or Disease

  • Obsessive-Compulsive Disorder

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Active, not recruiting
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 120 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jun 01, 2016
    Primary Completion: Jun 01, 2023 ESTIMATED
    Completion Date: Jun 01, 2023 ESTIMATED
    Study First Posted: Dec 08, 2015 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Mar 07, 2023

    Sponsors / Collaborators

    Lead Sponsor: Stanford University
    Responsible Party: N/A

    Location

    Stanford, California, USA

    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.

    Participant Groups

    • 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

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    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

    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

    Primary Outcomes

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

    More Details

    NCT Number: NCT02624596
    Acronym: MKET
    Other IDs: 34622
    Study URL: https://clinicaltrials.gov/study/NCT02624596
    Last updated: Sep 29, 2023