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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 99 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Interventions: (2R,6R)-hydroxynorketamine (0.25 to 2.0 mg/kg) (Drug), Placebo (Drug) to (2R,6R)-hydroxynorketamine (0.25 to 2.0 mg/kg) (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 44 words
    • Secondary endpoints: details revised at 1 of 8 entries
    • Study description shortened, about 5 words
  2. 4 versions Re-verified since Jun 13, 2026, no change to tracked fieldsv95-v98
  3. Site contact updatedv94
  4. Re-verified, no change to tracked fieldsv93
  5. Eligibility criteria expanded, about 25 words
    • Site contact updated
    v92
Show 42 earlier versionsHide 42 earlier versions
  1. 7 versions Re-verified since Jan 3, 2025, no change to tracked fieldsv85-v91
  2. Study Status, Eligibilityv84
  3. Site contact updatedv83
  4. Start date changed from estimate of Nov 25, 2024 to Nov 6, 2024v82
  5. Start date: Nov 24, 2024 to Nov 25, 2024v81
  6. Start date: Nov 21, 2024 to Nov 24, 2024v80
  7. Start date: Nov 20, 2024 to Nov 21, 2024v79
  8. Start date: Nov 19, 2024 to Nov 20, 2024v78
  9. Start date: Nov 18, 2024 to Nov 19, 2024v77
  10. Start date: Nov 17, 2024 to Nov 18, 2024v76
  11. Start date: Nov 14, 2024 to Nov 17, 2024v75
  12. Start date: Nov 13, 2024 to Nov 14, 2024v74
  13. Start date: Nov 12, 2024 to Nov 13, 2024v73
  14. Start date: Nov 11, 2024 to Nov 12, 2024v72
  15. Start date: Nov 10, 2024 to Nov 11, 2024v71
  16. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 7, 2024 to Nov 10, 2024
    v70
  17. Start date: Nov 5, 2024 to Nov 7, 2024v69
  18. Start date: Nov 4, 2024 to Nov 5, 2024v68
  19. Start date: Nov 3, 2024 to Nov 4, 2024v67
  20. Start date: Oct 31, 2024 to Nov 3, 2024v66
  21. Start date: Oct 30, 2024 to Oct 31, 2024v65
  22. Start date: Oct 29, 2024 to Oct 30, 2024v64
  23. Start date: Oct 28, 2024 to Oct 29, 2024v63
  24. Start date: Oct 25, 2024 to Oct 28, 2024v62
  25. Start date: Oct 24, 2024 to Oct 25, 2024v61
  26. Start date: Oct 23, 2024 to Oct 24, 2024v60
  27. Start date: Oct 21, 2024 to Oct 23, 2024v59
  28. Start date: Oct 20, 2024 to Oct 21, 2024v58
  29. Start date: Oct 17, 2024 to Oct 20, 2024v57
  30. Start date: Oct 16, 2024 to Oct 17, 2024v56
  31. Start date: Oct 15, 2024 to Oct 16, 2024v55
  32. Start date: Oct 14, 2024 to Oct 15, 2024v54
  33. Start date: Oct 13, 2024 to Oct 14, 2024v53
  34. Start date: Oct 9, 2024 to Oct 13, 2024v52
  35. Start date: Oct 8, 2024 to Oct 9, 2024v51
  36. Start date: Oct 7, 2024 to Oct 8, 2024v50
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: Major depressive disorder (MDD) is a serious mental illness that can put people at risk of self-harm and death. Many drugs are used to treat MDD, but it can take a long time for them to be effective. Researchers want to know if a faster-acting drug, (2R,6R)-hydroxynorketamine (HNK), can better treat the symptoms of MDD. Objective: To test a study drug (HNK) in people with MDD. Eligibility: People aged 18 to 70 years with MDD. They must have had a screening assessment under protocol 01-M-0254. Design: Participants will be tapered off their current MDD drugs over 2 to 5 weeks. They will stay off of the drugs for up to 2 weeks prior to starting the study medication and procedures. They will have a physical exam with blood tests. They will have tests of their heart function, mood, and thinking. They will answer questions about their symptoms. They may choose to have imaging scans and scans of their brain activity. HNK is given through a tube attached to a needle inserted into a vein. Participants will receive infusions on this schedule: They will receive 4 infusions over 2 weeks. They will stay in the clinical center overnight after each infusion or for the duration of the study. They will receive no drugs for 2 to 3 weeks. They will have 4 more infusions over 2 weeks, with overnight stays after each or for the duration of the study. One set of 4 infusions will be the HNK. The other set of 4 infusions will be a placebo. A placebo looks just like the real drug but contains no medicine. Participants will not know when they are getting the HNK or placebo. ...
Trial Details
NCT Number NCT06511908
Lead Sponsor National Institute of Mental Health (NIMH)
Conditions
(from sponsor)		 Suicide, Depressive Disorder, Treatment-Resistant, Ketamine, Molecular Mechanisms of Pharmacological Action, Neurotransmitter Agents, Excitatory Amino Acid Agents, Physiological Effects of Drugs, Depressive Disorder, Major +5 more
Related terms Behavioral Symptoms, Depression, Depressive Disorder, Depressive Disorder, Treatment-Resistant, Major Depressive Disorder, Mental Disorders, Mood Disorders, Suicide
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov