Understanding how ketamine affects OCD symptoms
Examining Mu Opioid Mechanisms of Ketamine's Rapid Effects in OCD (MKET2)
This study is testing whether ketamine can help people with OCD who haven't found relief from other treatments by looking at how it affects their brain activity.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT05940324 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the mechanisms by which ketamine alleviates symptoms of Obsessive-Compulsive Disorder (OCD) by examining its opioid properties and their impact on brain circuitry. Participants will receive either ketamine, naltrexone, or a placebo, and their brain activity will be monitored using MRI. The study focuses on individuals who have not responded to standard OCD treatments, providing insights into alternative therapeutic approaches. By exploring the interaction between ketamine and the brain's fronto-striatal circuitry, the research seeks to enhance understanding of OCD treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of OCD who have failed at least one prior standard treatment.
Not a fit: Patients with prior exposure to naltrexone or ketamine, or those with contraindications for MRI, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new, effective treatment options for patients with OCD who have not benefited from traditional therapies.
How similar studies have performed: While the specific approach of examining ketamine's opioid mechanisms in OCD is novel, there have been successful studies exploring ketamine's rapid effects on other mental health conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Eligibility Criteria for Participants with OCD: Inclusion Criteria: * Ages 18-65 * Meet the criteria for OCD diagnosis * Failed at least 1 prior trial of standard first-line OCD treatment * Agree to the following lifestyle modifications: comply with requirements for fasting prior to the Experimental Session, not enroll in any other interventional clinical trials during the duration of the study, and commit to medication study procedures. * Able to provide informed consent Exclusion Criteria: * prior naltrexone or ketamine use/exposure * Any current or past medical/psychiatric condition that makes participation unsafe in the opinion of the investigator or study physician * Pregnant or nursing, or able to become pregnant and are not practicing an effective means of birth control * the presence of metal in the body that is contraindicated for MRI scans Eligibility Criteria for Healthy Volunteers: Inclusion Criteria: * Ages 18-65 * Able to provide informed consent Exclusion Criteria: * current or past use of psychotropic medication * pregnant or nursing females * the presence of metal in the body that is contraindicated for MRI scans
Where this trial is running
Stanford, California
- Department of Psychiatry & Behavioral Sciences — Stanford, California, United States (Recruiting)
Study contacts
- Study coordinator: Pavithra Mukunda, MS
- Email: ocdresearch@stanford.edu
- Phone: 6504972578
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.