A Randomized, Double-Blind Controlled Comparison of NRX-101 to Lurasidone for Adults With Bipolar Depression and Subacute Suicidal Ideation or Behavior

NRX101_003

NMDA antagonist drugs have shown to reduce symptoms of depression and suicidal ideation. NeuroRx has developed NRX-101 (fixed dose combination of D-cycloserine and lurasidone) for oral use in the treatment of bipolar depression with suicidal ideation. This study will test the hypothesis that NRX-101 is superior to lurasidone alone (standard of care) in maintaining remission from symptoms of depression (primary endpoint) and suicidal ideation or behavior (declared secondary endpoint) over a six week period of twice-daily oral dosing.

2022-05-12

2024-02-28

2024-03-30

Completed

Early phase I

74

Inclusion Criteria: * 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) Exclusion Criteria: * 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 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 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) * Subject has signs and symptoms of active or residual COVID-19, or unresolved symptoms of COVID-19 that impact health

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2024-05-08