Pilot Study of RR-HNK in OCD

NCT06575075 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 57628
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

OCD; AMPA receptor antagonist; hydroxynorketamine; ketamine metabolite

Outcome Measures

Primary Outcomes (1)

• Change in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)

  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.

  Baseline (Visit 3) to Week 1 (Visit 8), up to 1 week

Study Arms (3)

0.25 mg/kg RR-HNK

EXPERIMENTAL

OCD patients in this arm will receive 0.25mg/kg of RR-HNK - one single infusion. EEG and computerized behavioral tests will be acquired before and after infusion.

Drug: RR-HNK/Hydroxynorketamine

0.5 mg/kg RR-HNK

EXPERIMENTAL

OCD patients in this arm will receive 0.5mg/kg of RR-HNK - one single infusion. EEG and computerized behavioral tests will be acquired before and after infusion.

Drug: RR-HNK/Hydroxynorketamine

Placebo (Sterile Saline)

PLACEBO COMPARATOR

OCD patients in this arm will receive sterile saline - one single infusion. EEG and computerized behavioral tests will be acquired before and after infusion.

Drug: Placebo

Interventions

RR-HNK/Hydroxynorketamine DRUG

(2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine and a glutamate AMPA receptor antagonist.

Also known as: (2R,6R)-Hydroxynorketamine

0.25 mg/kg RR-HNK; 0.5 mg/kg RR-HNK

Placebo DRUG

Sterile Saline

Placebo (Sterile Saline)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carolyn Rodriguez: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Stanford University School of Medicine

Palo Alto, California, 94305, United States

RECRUITING

Related Links

• A Phase 1 Assessment of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of (2R,6R)-Hydroxynorketamine in Healthy Volunteers

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

6-hydroxynorketamine

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Carolyn Rodriguez, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Izzy Vo, BS

CONTACT

650-723-4095; ocdresearch@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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)

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: January 23, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2029
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)