Pilot Study of RR-HNK in OCD
ConditionObsessive-Compulsive Disorder
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCarolyn Rodriguez
About this trial
The purpose of this study is to understand how RR-HNK works in the brain to bring about a reduction in OCD symptoms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
RR-HNK/Hydroxynorketamine
Drug(2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine and a glutamate AMPA receptor antagonist.
Placebo
DrugSterile Saline
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: 0.25 mg/kg RR-HNKExperimental treatment 1 intervention
Group B: 0.5 mg/kg RR-HNKExperimental treatment 1 intervention
Group C: Placebo (Sterile Saline)Placebo comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline (Visit 3) to Week 1 (Visit 8), up to 1 weekSponsors and contacts
Click on the lead sponsor to view all of their trials.
Carolyn Rodriguez
Lead sponsor
Stanford University
Sponsor institution
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov