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
Visit trial
Status Not yet recruiting
Results Published No
Start date 14 August 2024
End date 01 July 2027
Phase Phase II
Design Blinded
Type Interventional
Generation Second
Participants 50
Sex All
Age 18- 70
Therapy No

Trial Details

This study aims to evaluate the effectiveness of (2R,6R)-hydroxynorketamine (HNK) in treating major depressive disorder (MDD), a severe mental illness. Adults aged 18-70 with MDD will first taper off their current medications, undergo physical and psychological assessments, and may have brain imaging. Participants will then receive 8 infusions over 4 weeks—4 with HNK and 4 with a placebo—administered in two phases, with a break in between. The study is double-blind, so participants will not know whether they are receiving HNK or the placebo.

NCT Number NCT06511908

Sponsors & Collaborators

National Institute of Mental Health
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Data attribution

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