RR-HNK for OCD

((HNKO) Trial)

Overseen By Pavithra Mukunda, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Carolyn Rodriguez

Disqualifiers: Allergy to ketamine, Pregnancy, others

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called RR-HNK to assess its potential in reducing symptoms of OCD (Obsessive-Compulsive Disorder). Participants will receive either a single infusion of RR-HNK at varying doses or a placebo (a harmless saline solution) for comparison. Researchers will conduct brain activity tests to understand RR-HNK's effects on the brain. Individuals diagnosed with OCD who have not found success with standard treatments might be suitable for this study. As a Phase 1/Phase 2 trial, this research aims to understand how RR-HNK works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to be among the first to potentially benefit from this new treatment.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, you must commit to the medication study procedures, which might involve changes to your medication routine.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that RR-HNK is generally safe for people. Safety checks found only minor side effects. In an earlier study, researchers tested RR-HNK on healthy individuals, and it was well-tolerated with few side effects. These results suggest that most people handle the treatment well, making it a promising option for those considering joining a clinical trial for OCD. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for OCD?

Researchers are excited about RR-HNK as a treatment for OCD because it represents a fresh approach compared to traditional options like SSRIs and CBT. Unlike these treatments, which often take weeks to show results, RR-HNK, derived from ketamine, could potentially offer rapid relief after just a single infusion. It works by modulating the brain's glutamate system, a different pathway from the serotonin-targeting mechanisms of standard therapies. This unique action might provide a faster onset of improvement, offering hope for patients who don't respond well to existing treatments.

What evidence suggests that RR-HNK might be an effective treatment for OCD?

Research suggests that RR-HNK, which participants in this trial may receive, might help reduce symptoms of OCD (obsessive-compulsive disorder). Studies have shown that medications affecting brain chemicals like glutamate, such as ketamine, can lessen OCD symptoms. RR-HNK resembles ketamine and targets glutamate in the brain similarly. Early findings indicate that RR-HNK could improve OCD symptoms. Although more research is needed, initial results are promising for those with OCD. ^{1 4 6 7 8}

Who Is on the Research Team?

Carolyn Rodriguez, MD, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with a diagnosis of OCD who haven't had success with or have refused standard treatments like SRI/CBT. Participants must consent to the study, follow fasting requirements before infusion sessions, avoid other clinical trials during this study, and commit to its procedures.

Inclusion Criteria

Able to provide informed consent

I have tried or refused standard OCD treatments like SRI or CBT.

I am between 18 and 65 years old.

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

I am not pregnant, nursing, or if capable of becoming pregnant, I am using effective birth control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single infusion of either 0.25 mg/kg or 0.5 mg/kg RR-HNK or placebo. EEG and computerized behavioral tests are conducted before and after infusion.

1 week

Multiple visits for infusion and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment using the YBOCS scale.

1 week

Follow-up visits for assessments

What Are the Treatments Tested in This Trial?

Interventions

• RR-HNK

Trial Overview The trial is testing RR-HNK, a potential new treatment for reducing OCD symptoms. It's compared against a placebo in participants. The focus is on how RR-HNK affects brain function related to OCD symptom improvement.

How Is the Trial Designed?

Group I: 0.5 mg/kg RR-HNK Experimental Treatment 1 Intervention

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 II: 0.25 mg/kg RR-HNK Experimental Treatment 1 Intervention

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 III: Placebo (Sterile Saline) Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Carolyn Rodriguez

Lead Sponsor

Trials

2

Recruited

90+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06575075

NCT06575075 | Pilot Study of RR-HNK in OCD 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. This protocol ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3799067/

Randomized Controlled Crossover Trial of Ketamine in ... This is the first randomized, controlled trial to demonstrate that a drug affecting glutamate neurotransmission can reduce OCD symptoms without the presence of ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06575075/pilot-study-of-rr-hnk-in-ocd

Pilot Study of RR-HNK in OCD | Clinical Research Trial ... The purpose of this study is to understand how RR-HNK works in the brain to bring about a reduction in OCD symptoms.

4. neuroscience.stanford.edu neuroscience.stanford.edu/news/ocd-and-ketamine

OCD and Ketamine | Wu Tsai Neurosciences Institute We're taking a deep dive into the neuroscience of obsessive-compulsive disorder (OCD) and the recent discovery that the anesthetic ketamine can give patients a ...

5. withpower.com withpower.com/trial/phase-2-compulsive-personality-disorder-11-2024-5b539

RR-HNK for OCD ((HNKO) Trial) The purpose of this study is to understand how RR-HNK works in the brain to bring about a reduction in OCD symptoms. Who Is on the Research Team? CR. Carolyn ...

6. ctv.veeva.com ctv.veeva.com/study/pilot-study-of-rr-hnk-in-ocd

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

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12167270/

Artificial Intelligence in Obsessive-Compulsive Disorder Obsessive-compulsive disorder (OCD) is a chronic and disabling condition, often leading to significant functional impairments.

8. researchgate.net researchgate.net/publication/382564694_A_Phase_1_Assessment_of_the_Safety_Tolerability_Pharmacokinetics_and_Pharmacodynamics_of_2R6R-Hydroxynorketamine_in_Healthy_Volunteers

(PDF) A Phase 1 Assessment of the Safety, Tolerability ... Safety assessments showed RR‐HNK possessed a minimal adverse ... Collectively, these data demonstrate RR‐HNK is well tolerated with ...