Pilot Study of RR-HNK in OCD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RR-HNK/Hydroxynorketamine, Placebo.
- Who it may be relevant to
- Registry conditions: Obsessive-Compulsive Disorder. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Double-blind, Placebo-controlled Study to Determine the Safety and Feasibility of Two Doses of Intravenous (2R, 6R)-Hydroxynorketamine (RR-HNK) in Adults With Obsessive-Compulsive Disorder
Overview
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
- Drug RR-HNK/Hydroxynorketamine
(2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine and a glutamate AMPA receptor antagonist. - Drug Placebo
Sterile Saline
Primary outcome measures
- Change in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS) [Time frame: Baseline (Visit 3) to Week 1 (Visit 8), up to 1 week]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Stanford University School of Medicine — Palo Alto
Identifiers
NCT: NCT06575075 · 57628