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

Carolyn Rodriguez

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Obsessive-Compulsive Disorder

Treatments: Drug: Placebo; Drug: RR-HNK/Hydroxynorketamine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06575075

57628

Details and patient eligibility

About

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

Full description

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

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 3 patient groups, including a placebo group

0.25 mg/kg RR-HNK

Experimental group

Description:

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.

Treatment:

Drug: RR-HNK/Hydroxynorketamine

0.5 mg/kg RR-HNK

Experimental group

Description:

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.

Treatment:

Drug: RR-HNK/Hydroxynorketamine

Placebo (Sterile Saline)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo