NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation
The SevereBD study will test the hypothesis that NRX-101 is superior to lurasidone alone in maintaining remission from symptoms of depression, clinical relapse, and suicidal ideation/behavior over a six-week period of twice-daily oral dosing in patients stabilized with ketamine (n=72; 2:1 randomization).
Details
This multi-centre, randomized, stratified, double-blind, parallel-group Phase III trial evaluates oral NRX-101 (fixed-dose D‑cycloserine + lurasidone) versus lurasidone alone for maintenance of remission in adults with severe bipolar depression and acute suicidal ideation/behavior after initial stabilization with an IV ketamine infusion.
Primary endpoint is maintenance of improvement on MADRS-10; key secondary endpoints include time to relapse of suicidality or depression and safety/tolerability measures. Randomization is 2:1 favoring NRX-101 with titration to target daily doses (DCS 950 mg + lurasidone 66 mg) administered twice daily for six weeks.