A Study of Brexpiprazole Plus Ketamine in Treatment-Resistant Depression (TRD)
Randomised, double-blind, placebo-controlled five-site trial (n=51) testing oral brexpiprazole (up to 3 mg/day) versus placebo combined with intranasal ketamine (40 mg, six administrations over 4 weeks) added to stable antidepressant therapy for adults with TRD.
Details
Five-site, randomised, quadruple-blind, parallel-group study evaluating the acute efficacy of adjunctive oral brexpiprazole versus placebo when combined with intranasal ketamine in adults with treatment-resistant major depressive disorder.
Participants continue stable antidepressant therapy and receive brexpiprazole titrated up to 3 mg/day or matching placebo for four weeks with intranasal ketamine 40 mg administered twice weekly for two weeks then weekly for two weeks (six administrations total); primary outcomes assess depressive symptom change (MADRS) and safety.
Key eligibility includes MADRS >20, documented TRD per MGH ATRQ, BMI 18–35 kg/m2, and medical stability; major exclusions include primary psychotic or bipolar disorders, recent substance use disorder, significant cardiovascular or neurological illness, and pregnancy.