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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (visit 2) to post infusion fmri scan (visit 4; day 1), up to 1 week

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