Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing (2R,6R)-hydroxynorketamine (0.25 to 2.0 mg/kg) for Suicide

Background: Major depressive disorder (major depression) is a serious mental illness that can put people at risk of self-harm and death. Many drugs are used to treat major depression, but it can take a long time for them to be effective.

Official registry: https://clinicaltrials.gov/study/NCT06511908 · National Institute of Mental Health (NIMH) · enrollment listed as 50

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are (2R,6R)-hydroxynorketamine (0.25 to 2.0 mg/kg), or Placebo. The registry lists allocation as randomized. Background: Major depressive disorder (major depression) is a serious mental illness that can put people at risk of self-harm and death.

They plan to enroll about 50 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: (2R,6R)-hydroxynorketamine (0.25 to 2.0 mg/kg), Placebo

Primary outcome (registry wording): Change from baseline on Montgomery-Asberg Depression Rating Scale total scores

Who it is for (from inclusion criteria)

  • Ages 18 Years to 70 Years
  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • 18 to 70 years of age
  • All participants must have undergone a screening assessment under protocol 01-M-0254
  • Participants must have an initial score of \>= 20 on the MADRS and a YMRS score of \<12 within one week of study entry and upon entry into Phase II
  • Ability to take intravenous medication and be willing to adhere to the (2R,6R)-HNK regimen
  • For individuals of reproductive potential: use of highly effective contraception starting at the time of enrollment and agreement to use such a method during study participation and for an additional four weeks after the end of Study Phase II

Public study contact (from the registry)

Solaleh Azimipour

(301) 768-0049

solaleh.azimipour@nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT06511908 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06511908?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06511908?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary