Obsessive-Compulsive Disorder
Conditions
Keywords
OCD, Ketamine, Naltrexone, MRI, Brain Imaging, OCD symptoms, Obsessive-Compulsive Disorder
Brief summary
The purpose of this study is to understand how ketamine works in the brain to bring about a reduction in OCD symptoms.
Detailed description
The proposed mechanistic trial would be the first to probe the role of ketamine's opioid properties in modulating fronto-striatal circuitry and bringing about reduction of OCD symptoms.
Interventions
DRUGKetamine
Ketamine is an FDA-approved dissociative anesthetic.
DRUGNaltrexone Pill
Naltrexone is an oral opioid antagonist approved by the Food and Drug Administration (FDA) to treat both alcohol use disorder (AUD) and opioid use disorder (OUD)
OTHERPlacebo pill
An oral inactive placebo pill will be administered to preserve the blinded nature of the study.
Sponsors
National Institute of Mental Health (NIMH)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants will be randomized with a 1:1 allocation to either IV ketamine + oral placebo or IV ketamine + oral opioid antagonist naltrexone
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS) | Baseline (Visit 2) to Post Infusion fMRI scan (Visit 4; Day 1), up to 1 week | Change 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. |
Countries
United States
Contacts
Primary ContactPavithra Mukunda, MS
Backup ContactCarolyn I Rodriguez, MD, PhD
Outcome results
None listed