NRX-101 for Bipolar Depression With Subacute Suicidal Ideation

Prior treatment

• Subject has current DSM-5 diagnosis of moderate or severe substance use disorder (except marijuana or tobacco use disorder) within the 12 months prior to Screening.
• Subject has been prescribed more than one agent in each of the following categories at randomization:
  • Approved SSRIs
  • Approved serotonin and norepinephrine reuptake inhibitors (SNRIs)
  • Approved tetracyclic antidepressants (TeCAs)
  • Approved Mood stabilizers (e.g., lithium, valproic acid, and lamotrigine)

Other illness

• Subject has a lifetime history of:
  • phencyclidine (PCP)/ketamine drug abuse, or
  • failed use of ketamine for depression or suicidality.
• Subject has schizophrenia or schizoaffective disorder, or any history of psychotic symptoms when not in an acute bipolar mood episode.
• Subject has a current major psychiatric disorder, diagnosed at Screening
• Subject has signs and symptoms of active or residual COVID-19, or unresolved symptoms of COVID-19 that impact health

• Diagnosed with bipolar disorder by a qualified rater according to the criteria defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and supported by the Mini International Neuropsychiatric Interview (MINI) 7.0.2.
• Confirmed active suicidal ideation (without the intention to act) as evidenced by an answer of 'Yes' on item 3 and/or item 4 and not requiring hospitalization at Screening and an answer of "No" on item 5 of the C-SSRS.
• A total score greater than or equal to 30 on the 10 items of the MADRS.
• Subject has no co-morbidities as ascertained by medical history, physical examination (including measurement of vital signs), clinical laboratory evaluations, and electrocardiogram (ECG)