NRX100 vs. Placebo for Rapid Stabilization of Acute Suicidal Ideation and Behavior in Bipolar Depression
This study will test the hypothesis that that NRX-100 is superior to placebo in achieving rapid reduction in symptoms of depression and suicidal ideation in patients with Severe Bipolar Depression and Acute Suicidal Ideation or Behavior within 24 hours of administration.
Details
Multi-centre, randomised, double-blind, parallel-group trial (3:1 randomisation) comparing a single IV infusion of NRX-100 (ketamine 0.5 mg/kg over 40 minutes) versus saline in patients with severe bipolar depression and acute suicidal ideation/behaviour (n=150).
Responders are offered enrolment in a six-week maintenance study of NRX-101 (oral fixed-dose d-cycloserine plus lurasidone) to assess maintenance of effect versus standard of care; primary outcome assesses rapid stabilisation and change in MADRS at day 1 and day 2.