Open-label, single-group Phase II study (n=5) of IV ketamine 0.5 mg/kg weekly ×4 plus a single IM naltrexone 380 mg injection for patients with major depressive disorder and alcohol use disorder.
This open-label single-group Phase II study evaluated repeated IV ketamine (0.5 mg/kg weekly for four infusions) combined with a single IM naltrexone 380 mg injection in participants with major depressive disorder and comorbid alcohol use disorder.
Primary objectives were to assess rapid antidepressant effects and changes in alcohol consumption; safety and tolerability were monitored throughout the treatment course.
Open-label single-group treatment: IV ketamine infusions weekly ×4 plus single IM naltrexone injection.
IV ketamine 0.5 mg/kg per infusion, 4 infusions total.
IM naltrexone 380 mg, single injection.