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Study details
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Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resistant Depression

National Institute of Mental Health (NIMH)
NCT IDNCT06511908ClinicalTrials.gov data as of Apr 2026
Phase

Phase 2

Target enrollment

50

Study length

about 2.6 years

Ages

18–70

Locations

1 site in MD

About this study

Researchers are testing a treatment called (2R,6R)-hydroxynorketamine (HNK) to see if it can help people with depression who haven't responded well to other treatments. The trial will last for 967 days and involve giving HNK or a placebo through an IV infusion over several weeks.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take (2R,6R)-hydroxynorketamine (0.25 to 2.0 mg/kg)
  • 2.Take Placebo
PhasePhase 2
Primary goalChange from baseline on Montgomery-Asberg Depression Rating Scale total scores

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low15%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Endpoints

Primary: Change from baseline on Montgomery-Asberg Depression Rating Scale total scores

Secondary: Change from baseline on Montgomery-Asberg Depression Rating Scale total scores, Change from baseline on item 10 (suicidality) of the Montgomery-Asberg Depression Rating Scale and total score on the Columbia Suicide Severity Rating Scale and the Scale for Suicide Ideation., Change from baseline on the Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, Positive and Negative Affect Schedule, Snaith-Hamilton Pleasure Scale, Temporal Experience of Pleasure Scale, and cognitive tasks., Incidence of AEs and total scores using the Clinician Administered Dissociative States Scale, Young Mania Rating Scale, Brief Psychiatric Rating Scale, vital signs, changes in clinical laboratory evaluations, and electrocardiograms., Pain thresholds and tolerance during quantitative sensory testing while undergoing fMRI., Pain thresholds and tolerance during quantitative sensory testing., Proportion of participants achieving response (defined as a >/=50% reduction from baseline in Montgomery-Asberg Depression Rating Scale total score), Proportion of participants in remission (defined as Montgomery-Asberg Depression Rating Scale total score =10)

Body systems

Psychiatry / Mental Health