At a glance
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Sequential Therapy (NRX-100 Followed by NRX-101) for the Treatment of Acute Suicidal Ideation and Behavior in Bipolar Depression: the STABIL-B Study
In Brief
A Phase 2 clinical trial evaluating NRX-101 Oral Capsule, Lurasidone Oral Capsule, and 2 other interventions for Bipolar Depression and 3 related conditions. Completed, enrolled 22 participants across 4 sites.
Detailed Summary
NeuroRx is developing NRX-101, a fixed-dose combination oral capsule composed of d-cycloserine (DCS) and lurasidone for the maintenance of remission from Severe Bipolar Depression with Acute Suicidal Ideation (C-SSRS level 4 or 5) or Behavior (ASIB) in following initial stabilization. Patients with Severe Bipolar Depression and ASIB will be recruited in both inpatient and outpatient settings and, following informed consent, will be given an intravenous infusion of ketamine 0.5mg/kg over 40 minutes. Those who exhibit a satisfactory clinical response to ketamine will be randomly allocated to NRX-101 or to lurasidone alone (the comparator group). This study is conducted as a feasibility study for a pivotal phase 2b/3 clinical trial and the primary outcomes for this phase 2 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.
Study Details
Timeline
Interventions
Prospective Randomized Factorial Design Study as per arm/group descriptions
Prospective Randomized Factorial Design Study as per arm/group descriptions
Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
Randomized administration of Ketamine or Placebo in a 3 to 1 ratio