Trial Profile
Administration of Intravenous NRX100 (Ketamine) vs Placebo Infusion for Rapid Stabilization of Acute Suicidal Ideation and Behavior in Patients With Bipolar Depression
Status:
Active, no longer recruiting
Phase of Trial:
Phase III
Latest Information Update: 16 Apr 2024
Price :
$35
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At a glance
- Drugs Ketamine (Primary) ; Cycloserine/lurasidone
- Indications Bipolar depression; Suicidal ideation
- Focus Registrational; Therapeutic Use
- Acronyms SevereBD
- Sponsors NeuroRX; NRx Pharmaceuticals
- 08 Apr 2024 According to a NRx Pharmaceuticals media release, the Company has also announced plans to submit a New Drug Application to FDA this quarter for the use of ketamine as a short-term therapy for suicidal bipolar depression.
- 28 Mar 2024 According to a NRx Pharmaceuticals media release, the company anticipates filing of New Drug Application for treatment of Acute Suicidality by June 2024 upon completion of required 9 month stability and CMC with anticipated 2024 PDUFA date.
- 01 Mar 2024 According to a NRx Pharmaceuticals media release, In the coming months, company expects to receive data from this clinical trial.