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Ketamine for Obsessive-Compulsive Disorder (MKET2 Trial)

Phase 2
Recruiting
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (visit 2) to post infusion fmri scan (visit 4; day 1), up to 1 week
Awards & highlights

Summary

This trial aims to investigate how ketamine affects the brain to reduce symptoms of OCD.

Who is the study for?
This trial is for adults aged 18-65 with Obsessive-Compulsive Disorder (OCD) who haven't improved after trying at least one standard treatment. Participants must agree to fast before sessions, not join other trials during this study, and commit to the medication procedures.
What is being tested?
The study tests how ketamine affects OCD symptoms compared to a placebo. It also examines if blocking opioid receptors with naltrexone changes ketamine's effects. Patients are randomly given either ketamine or placebo, and some will receive naltrexone.
What are the potential side effects?
Ketamine may cause side effects like disorientation, elevated blood pressure, nausea, mood swings, and dissociation (feeling disconnected). Naltrexone can lead to headaches, stomach pain, sleep problems, and anxiety.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (visit 2) to post infusion fmri scan (visit 4; day 1), up to 1 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (visit 2) to post infusion fmri scan (visit 4; day 1), up to 1 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Ketamine + NaltrexoneExperimental Treatment2 Interventions
OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion. fMRI will be acquired before, during, and after infusion. Oral naltrexone 50 mg will be administered before the infusion.
Group II: Healthy VolunteersActive Control1 Intervention
Healthy volunteers will have one fMRI scan visit.
Group III: Ketamine + PlaceboPlacebo Group2 Interventions
OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion. fMRI will be acquired before, during, and after infusion. An oral inactive placebo will be administered before the infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
2011
Completed Phase 4
~1120
Naltrexone Pill
2021
Completed Phase 4
~220

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,448 Previous Clinical Trials
17,492,244 Total Patients Enrolled
15 Trials studying Obsessive-Compulsive Disorder
1,253 Patients Enrolled for Obsessive-Compulsive Disorder
National Institute of Mental Health (NIMH)NIH
2,869 Previous Clinical Trials
2,777,386 Total Patients Enrolled
65 Trials studying Obsessive-Compulsive Disorder
13,772 Patients Enrolled for Obsessive-Compulsive Disorder
~100 spots leftby Nov 2028
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