Study Results
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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RECRUITING
PHASE1/PHASE2
45 participants
INTERVENTIONAL
2025-11-01
2029-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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.
RR-HNK/Hydroxynorketamine
(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.
RR-HNK/Hydroxynorketamine
(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.
Placebo
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.
Placebo
Sterile Saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
Carolyn Rodriguez
OTHER
Responsible Party
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Carolyn Rodriguez
Professor
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
Countries
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Central Contacts
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Facility Contacts
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Daniel Bello, BS
Role: primary
Related Links
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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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