Trial Profile
Sequential Therapy (NRX-100 Followed by NRX-101) for the Treatment of Acute Suicidal Ideation and Behavior in Bipolar Depression: the STABIL-B Study
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 18 Aug 2023
Price :
$35
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At a glance
- Drugs Cycloserine/lurasidone (Primary) ; Ketamine; Lurasidone
- Indications Bipolar depression; Suicidal ideation
- Focus Proof of concept; Registrational; Therapeutic Use
- Acronyms STABIL-B
- Sponsors NeuroRX
- 14 Aug 2023 According to a NRx Pharmaceuticals media release, results of this trial was accepted for publication in the International Journal of Bipolar Disorders, a peer-reviewed publication (Nierenberg A, Lavin P, Javitt DC, et al. NRX-101 (D-cycloserine plus lurasidone) vs. lurasidone for the maintenance of initial stabilization after ketamine in patients with severe bipolar depression with acute suicidal ideation and behavior. a randomized prospective phase 2 trial.
- 14 Nov 2022 According to a NRx Pharmaceuticals media release, patients with bipolar depression and ASIB in the trial received either NRX-101 or lurasidone after an intravenous infusion of NRX-100 (ketamine).
- 14 Nov 2022 According to a NRx Pharmaceuticals media release, based on the findings of this trial FDA granted NRX-101 a Special Protocol Agreement ("SPA") for bipolar depression in patients with ASIB.