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STABIL-B: NRX-101 for Bipolar Depression with Suicidality
NCT02974010Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2018
- Primary completion
- Aug 2018
- Countries
- 1
- Sponsor
- NRx Pharmaceuticals
- Modality
- Orthosteric Ligands
- Conditions
- bipolar disorder (BD)suicidal ideation
01
Overview
Phase 2, randomised, double-blind trial of d-cycloserine + lurasidone in bipolar disorder (BD) and suicidal ideation (2 arms), sponsored by NRx Pharmaceuticals. Primary endpoints: BISS-derived MADRS Score Change From Baseline at Day 42 and Blood levels of NRX-101. Started Jan 2018; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
NRX-101
Ketamine stabilization followed by NRX-101 (D-cycloserine + lurasidone) maintenance
Lurasidone
Ketamine stabilization followed by Lurasidone maintenance
03
Who it enrols
Adults with Bipolar Disorder and severe depression (MADRS >= 20) with acute suicidal ideation or behavior (C-SSRS 4 or 5). Must respond to initial Ketamine infusion to be randomized.
04
Endpoints
Primary
BISS-derived MADRS Score Change From Baseline
Blood levels of NRX-101
Secondary
Relapse of Depression or Suicidality
05
Results
Primary endpoints met
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