Pilot Study of RR-HNK in OCD

Phase 2RecruitingNCT06575075

Carolyn Rodriguez45 enrolled

Overview

The purpose of this study is to understand how RR-HNK works in the brain to bring about a reduction in OCD symptoms.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Obsessive-Compulsive Disorder

Interventions

RR-HNK/HydroxynorketamineDRUG

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

PlaceboDRUG

Sterile Saline

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford University School of Medicine

Palo Alto, California, United States

RECRUITING

Outcomes

Primary Outcomes

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.

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

Central Contacts

Izzy Vo, BS

CONTACT

650-723-4095 ocdresearch@stanford.edu

Data from ClinicalTrials.gov

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