Sequential Therapy for the Treatment of Severe Bipolar Depression
This study is conducted as a feasibility study for a pivotal Phase IIb/3 clinical trial and the primary outcomes for this Phase II study were blood levels of NRX-101, in order to confirm pharmaco-kinetics with remission from depression, as measured by BISS-derived MADRS and relapse as secondary outcomes.
Details
Sequential, randomized, phase II feasibility study in adults with severe bipolar depression and acute suicidal ideation/behavior: initial randomized induction with IV ketamine (0.5 mg/kg over 40 minutes) or saline, then responders are randomised to NRX-101 (D-cycloserine + lurasidone) or lurasidone alone for maintenance (twice daily, up to 6 weeks).
Primary outcome: pharmacokinetic blood levels of NRX-101 and its D-cycloserine component with remission assessed by MADRS; secondary endpoints include relapse, suicidal outcomes, safety and tolerability.