Obsessive-Compulsive Disorder
Conditions
Keywords
OCD, AMPA receptor antagonist, hydroxynorketamine, ketamine metabolite
Brief summary
The purpose of this study is to understand how RR-HNK works in the brain to bring about a reduction in OCD symptoms.
Detailed description
This protocol examines the safety and efficacy of 2 dosage levels of intravenous RR-HNK administration in individuals with OCD.
Interventions
DRUGRR-HNK/Hydroxynorketamine
(2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine and a glutamate AMPA receptor antagonist.
DRUGPlacebo
Sterile Saline
Sponsors
Carolyn Rodriguez
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Participants will be randomized with a 1:1:1 allocation to either 0.25 mg/kg RR-HNK or 0.5 mg/kg IV RR-HNK + IV placebo (sterile saline)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Ages 18-65 * Meet the criteria for OCD diagnosis * Failed at least 1 prior trial of standard first-line OCD treatment (e.g. SRI/CBT) or or had refused these treatments for individual reasons * Agree to the following lifestyle modifications: comply with requirements for fasting prior to --the infusion 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
* Allergy or hypersensitivity to ketamine * 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 * Lifetime history of deep brain stimulation
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 3) to Week 1 (Visit 8), 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
CONTACTAlessa Gaeta, BA
PRINCIPAL_INVESTIGATORCarolyn Rodriguez, MD, PhD
Stanford University
Outcome results
None listed