Pilot Study of RR-HNK in OCD

NCT ID: NCT06575075

Last Updated: 2025-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2029-11-30

Brief Summary

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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

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This protocol examines the safety and efficacy of 2 dosage levels of intravenous RR-HNK administration in individuals with OCD.

Conditions

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Obsessive-Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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0.25 mg/kg RR-HNK

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.

Group Type EXPERIMENTAL

RR-HNK/Hydroxynorketamine

Intervention Type DRUG

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

0.5 mg/kg RR-HNK

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.

Group Type EXPERIMENTAL

RR-HNK/Hydroxynorketamine

Intervention Type DRUG

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

Placebo (Sterile Saline)

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Sterile Saline

Interventions

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RR-HNK/Hydroxynorketamine

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

Intervention Type DRUG

Placebo

Sterile Saline

Intervention Type DRUG

Other Intervention Names

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(2R,6R)-Hydroxynorketamine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Carolyn Rodriguez

OTHER

Sponsor Role lead

Responsible Party

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Carolyn Rodriguez

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Carolyn Rodriguez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Palo Alto, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Daniel Bello, BS

Role: CONTACT

650-723-4095

Facility Contacts

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Daniel Bello, BS

Role: primary

Related Links

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https://pubmed.ncbi.nlm.nih.gov/39054770/

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

Other Identifiers

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57628

Identifier Type: -

Identifier Source: org_study_id

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