RR-HNK treatment for obsessive-compulsive disorder.
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
This pilot will test whether two intravenous doses of RR-HNK can reduce symptoms in adults with obsessive-compulsive disorder who have not fully responded to standard treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT06575075 on ClinicalTrials.gov |
What this trial studies
Participants will receive one of two dosage levels of intravenous RR-HNK or a placebo with close monitoring for safety and side effects. The protocol combines Phase 1 safety measures with Phase 2 preliminary efficacy endpoints using standardized OCD symptom scales and clinical interviews. The study includes procedures to explore how RR-HNK affects brain function that may relate to symptom change. Visits take place at Stanford and require fasting before infusion and adherence to medication and visit procedures.
Who should consider this trial
Good fit: Adults 18–65 with a diagnosis of OCD who have failed at least one first-line treatment (such as SRIs or CBT) or who have declined those treatments, who can comply with study procedures and provide informed consent, are ideal candidates.
Not a fit: People who are pregnant or nursing, have an allergy to ketamine, have a medical or psychiatric condition that investigators deem unsafe, or have a history of deep brain stimulation will likely be ineligible and not receive benefit from this protocol.
Why it matters
Potential benefit: If successful, RR-HNK could provide a new, potentially faster-acting treatment option for people with OCD who have not benefited from standard therapies.
How similar studies have performed: Related approaches using ketamine and its metabolites have shown rapid symptom relief in depression and some case reports in OCD, but RR-HNK itself is a novel compound with limited human data to date.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Palo Alto, California
- Stanford University School of Medicine — Palo Alto, California, United States (Recruiting)
Study contacts
- Principal investigator: Carolyn Rodriguez, MD, PhD — Stanford University
- Study coordinator: Izzy Vo, BS
- Email: ocdresearch@stanford.edu
- Phone: 650-723-4095
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.