NRX101 for Moderate Bipolar Depression and Suicidal Ideation

Summary

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Description

Background and Rationale: NMDA antagonist drugs have increasingly been demonstrated to reduce symptoms of depression and suicidal ideation. Specifically, NRX-100 (ketamine HCl, 0.5 mg/kg IV over 40 minutes) has been shown to induce acute reductions in suicidality and depression in patients with bipo...

Background and Rationale: NMDA antagonist drugs have increasingly been demonstrated to reduce symptoms of depression and suicidal ideation. Specifically, NRX-100 (ketamine HCl, 0.5 mg/kg IV over 40 minutes) has been shown to induce acute reductions in suicidality and depression in patients with bipolar depression, relative to control. Numerous reports have documented a 50% reduction in the MADRS depression scale and a 75% reduction in suicidality following a single infusion of ketamine in patients with suicidal ideation and depression. While the repeat use of ketamine is not supported and may be contraindicated by the literature, D-cycloserine (DCS), when combined with SSRI antidepressants in patients with treatment resistant depression, and when combined with atypical antipsychotics, in particular lurasidone (NRX-101), has shown separation from control and ability to maintain remission from suicidality and depression over 6 weeks with oral use. Primary Objective: To test the hypothesis that treatment with NRX-101 is superior to lurasidone in maintaining improvement in symptoms of depression as measured by the Montgomery Asberg Depression Rating Score (MADRS). Secondary Objectives: To test the hypothesis that patients treated with NRX-101 are less likely to experience treatment failure than those treated with standard of care. Treatment failure is defined as a 25% or greater return to baseline levels of depression or suicidality, or the need to implement a new treatment plan. To demonstrate that patients treated with NRX-101 are less likely to suffer from akathisia than those treated with lurasidone. To demonstrate safety and tolerability for both NRX-101 vs. lurasidone. Methodology: A multi-center, randomized, double-blind, trial in which patients with moderate levels of bipolar depression (MADRS >20) and subacute levels of suicidal ideation (C-SSRS 2 or 3) are randomized to receive twice daily oral NRX-101 or lurasidone (standard of care).

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