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

This randomized, double-blind, placebo-controlled crossover trial (n=50) will investigate the efficacy and safety of (2R,6R)-hydroxynorketamine (HNK), an enhancer of synaptic glutamate release, in individuals with treatment-resistant major depressive disorder (MDD).

Participants, aged 18 to 70, will receive 0.25 to 2.0 mg/kg of HNK in four infusions over two weeks, followed by a placebo phase with the same schedule.

The study, conducted by the National Institute of Mental Health (NIMH), will compare HNK’s effects on depressive symptoms, with the primary outcome measured by changes in the Montgomery-Asberg Depression Rating Scale (MADRS). Secondary outcomes include assessments of mood, anxiety, and suicidality.

The study, starting in August 2024, is expected to be completed in July 2027.

Topic Depression Treatment-Resistant Depression
Country United States of America
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National Institute of Mental Health
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