NRX-101 for Bipolar Depression With Subacute Suicidal Ideation

Summary

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.

Timeline

Start

2022-05-12

Primary completion

2024-02-28

Completion

2024-03-30

Publications

• Sapko MT, Kolesar C, Sharp IR, Javitt JC. Quality Assurance of Depression Ratings in Psychiatric Clinical Trials. J Clin Psychopharmacol. 2025 Jan-Feb 01;45(1):28-31. doi: 10.1097/JCP.0000000000001936. Epub 2024 Nov 21.

Drugs

Indications