Clinical TrialObsessive-Compulsive Disorder (OCD)KetamineKetaminePlaceboRecruiting

Pilot Study of RR-HNK in OCD ((HNKO))

This double-blind, placebo-controlled trial (n=45) will study the safety and efficacy of two dosage levels of intravenous (2R,6R)-Hydroxynorketamine (RR-HNK) in adults with obsessive-compulsive disorder (OCD).

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Target Enrollment
45 participants
Study Type
Phase I/II interventional
Design
Randomized, triple Blind

Detailed Description

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

Randomized, parallel-group, triple-masked Phase I/II trial comparing single IV infusions of 0.25 mg/kg and 0.5 mg/kg RR-HNK versus sterile saline placebo in adults with OCD; EEG and computerized behavioural tests acquired before and after infusion.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

RR-HNK 0.25 mg/kg

experimental

Single IV infusion of 0.25 mg/kg RR-HNK with EEG and computerized behavioural tests pre/post.

Interventions

  • Ketamine0.25 mg/kg
    via IV• single dose• 1 doses total

    Single IV infusion; EEG and computerized behavioural tests before and after infusion.

RR-HNK 0.5 mg/kg

experimental

Single IV infusion of 0.5 mg/kg RR-HNK with EEG and computerized behavioural tests pre/post.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    Single IV infusion; EEG and computerized behavioural tests before and after infusion.

Placebo (Saline)

inactive

Single IV infusion of sterile saline (placebo) with EEG and computerized behavioural tests pre/post.

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    Sterile saline single IV infusion (placebo).

Participants

Ages
18 – 65
Sexes
Male & Female

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 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 or psychiatric condition that makes participation unsafe in the opinion of the investigator or study physician
  • Pregnant or nursing, or able to become pregnant and not practicing an effective means of birth control
  • Lifetime history of deep brain stimulation

Study Protocol, Arms & Participants

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Study Details

Locations

Stanford University School of Medicine — Palo Alto, California, United States

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