Double-blind randomised Phase III trial (n=30) testing eight IV ketamine infusions (0.5 mg/kg over 40 minutes, twice weekly) versus saline in adults 18–65 with treatment-resistant major depressive disorder, assessing clinical response and pgACC glutamate/GABA changes by H1-MRS.
Randomised, double-blind, parallel-group trial of IV ketamine (0.5 mg/kg) given twice weekly for 4 weeks (8 infusions) versus saline placebo in adults with treatment-resistant depression.
Primary clinical outcomes assess response by HDRS/MADRS in the first 24 hours and up to 12 weeks; mechanistic outcomes evaluate glutamate and GABA changes in the pgACC using H1-MRS at baseline, during infusion, 24 hours and 1 week after the final infusion.
Blinded phase is followed by an open-label extension where placebo recipients receive ketamine; safety monitoring includes vitals, adverse events and clinical assessments with 12-week follow-up.
IV ketamine 0.5 mg/kg over 40 minutes, twice weekly for 4 weeks (8 infusions).
Diluted in 100 mL saline 0.9% over 40 minutes; brands: Ketalar/Anesket
Saline 0.9% IV over 40 minutes, twice weekly; blinded placebo with later open-label ketamine crossover.
Saline 0.9% over 40 minutes; blinded phase then open-label crossover to ketamine for placebo arm