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Ketamine + Naltrexone 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
MKET2 Trial 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.Check my eligibility
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.See study design
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.
MKET2 Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
MKET2 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
~1090
Naltrexone Pill
2021
Completed Phase 4
~220
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,200 Total Patients Enrolled
15 Trials studying Obsessive-Compulsive Disorder
1,253 Patients Enrolled for Obsessive-Compulsive Disorder
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,559 Total Patients Enrolled
65 Trials studying Obsessive-Compulsive Disorder
13,831 Patients Enrolled for Obsessive-Compulsive Disorder
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals aged 65 and above eligible to participate in this research study?
"Individuals aged between 18 and 65 are eligible for inclusion in this clinical trial."
Answered by AI
What is the total number of participants being recruited for this research investigation?
"Indeed, information on clinicaltrials.gov confirms that recruitment is ongoing for this investigation. The trial was originally posted on February 24th, 2024 and last revised on March 13th, 2024. Enrollment aims to reach a total of 150 participants from a single site."
Answered by AI
Are researchers currently seeking participants for this study?
"As per the details available on clinicaltrials.gov, this study is currently in the process of enrolling participants. The trial was initially listed on 2/24/2024 and last revised on 3/13/2024."
Answered by AI
Has the combination of Ketamine and Naltrexone received clearance from the FDA for clinical use?
"Our team at Power has rated the safety of Ketamine + Naltrexone as 2 on a scale from 1 to 3. This rating is due to the current Phase 2 trial stage, which indicates some existing safety data but lacks efficacy evidence."
Answered by AI
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