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NMDA receptor antagonist

(2R,6R)-Hydroxynorketamine hydrochloride for Depression

Phase 1
Waitlist Available
Led By Shruti Raja, MD, MHS
Research Sponsored by National Institute of Mental Health (NIMH)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 days post dosing (sad), 12 days post dosing (mad)
Awards & highlights

Study Summary

This trial will test the safety and effects of a new drug given in different doses to healthy volunteers. The volunteers will have their standard safety parameters monitored, and the effects of the drug on their bodies will be studied.

Eligible Conditions
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 days post dosing (sad), 12 days post dosing (mad)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 days post dosing (sad), 12 days post dosing (mad) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of subjects with adverse events as a measure of safety and tolerability of (2R,6R)-Hydroxynorketamine
Pharmacokinetics of (2R,6R)-Hydroxynorketamine, area under the curve concentration (AUC)
Pharmacokinetics of (2R,6R)-Hydroxynorketamine, half-life (t1/2)
+2 more
Secondary outcome measures
Pharmacodynamics of (2R,6R)-Hydroxynorketamine, quantitative electroencephalography (qEEG) relative spectral power
Pharmacodynamics of (2R,6R)-Hydroxynorketamine, quantitative electroencephalography (qEEG) source localization
Pharmacodynamics of (2R,6R)-Hydroxynorketamine, quantitative electroencephalography (qEEG) visual evoked time-locked data

Trial Design

10Treatment groups
Experimental Treatment
Placebo Group
Group I: SAD Cohort 6Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 4.0 mg/kg via slow IV infusion (40 minutes)
Group II: SAD Cohort 5Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes)
Group III: SAD Cohort 4Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes)
Group IV: SAD Cohort 3Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 0.5 mg/kg via slow IV infusion (40 minutes)
Group V: SAD Cohort 2Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 0.25 mg/kg via slow IV infusion (40 minutes)
Group VI: SAD Cohort 1Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 0.1 mg/kg via slow IV infusion (40 minutes)
Group VII: MAD Cohort 2Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 2.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10
Group VIII: MAD Cohort 1Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 1.0 mg/kg via slow IV infusion (40 minutes) on days 1, 4, 7, 10
Group IX: CSF Capture Cohort 1Experimental Treatment1 Intervention
(2R,6R)-Hydroxynorketamine @ 0.25 mg/kg via slow IV infusion (40 minutes)
Group X: PlaceboPlacebo Group1 Intervention
Control product (placebo) will be sterile saline also administered via slow IV infusion (40 minutes).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
(2R,6R)-Hydroxynorketamine hydrochloride
2021
Completed Phase 1
~80

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Mental Health (NIMH)Lead Sponsor
2,783 Previous Clinical Trials
2,689,075 Total Patients Enrolled
666 Trials studying Depression
251,434 Patients Enrolled for Depression
Shruti Raja, MD, MHSPrincipal InvestigatorDuke University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for participants to join this clinical trial?

"Based on the readily available information, this clinical trial is presently recruiting participants. The study was initially posted on November 1st 2021 and its details were amended last April 25th 2022."

Answered by AI

What is the current capacity of this research project?

"Affirmative. According to clinicaltrials.gov, this medical study is presently recruiting patients after first launching on the 11th of January 2021 and last updating its records on April 25th 2022. The team behind the trial needs 80 individuals at one centre in order to complete their research."

Answered by AI

Has the Food and Drug Administration permitted (2R,6R)-Hydroxynorketamine hydrochloride for general use?

"Due to the limited data collected so far, our team at Power assigned (2R,6R)-Hydroxynorketamine hydrochloride a safety score of 1 on a scale that tops out at 3. This medical trial is currently in Phase 1 and has yet to provide sufficient evidence for efficacy or safety."

Answered by AI

Does this research effort encompass elderly participants aged 80 and over?

"In order to be eligible for this medical study, patients must have reached the age of consent and must not exceed 65 years old. There are 106 clinical trials available that cater specifically to those under 18 and 595 trial options for elderly individuals."

Answered by AI

Who meets the criteria to join this research program?

"This trial seeks approximately 80 participants who are afflicted with melancholia and aged between 18-65."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Virginia
How old are they?
18 - 65
What site did they apply to?
Duke Early Phase Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I’ve tried a lot of different ssris and snris along with esketamine and psilocybin. The latter two worked the best but I stopped in 2021 and the depression is back.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Phase 1 Evaluation of (2R,6R)-Hydroxynorketamine
2021. "Phase 1 Evaluation of (2R,6R)-Hydroxynorketamine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04711005.
~17 spots leftby Apr 2025
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