2 completed, 1 available, 1 not yet recruiting, 1 recruiting. 4 Phase 3, 3 Phase 2, 1 Early Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 4 | Completed 2, Recruiting 1, Unknown 1 |
| Phase 2 | 3 | Completed 2, Recruiting 1 |
| Early Phase 1 | 1 | Not yet recruiting 1 |
Follow NRX-101: new trials by email Literature Review of NRX-101 trials Research Report on NRX-101
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Randomized, Double-Blind Controlled Comparison of NRX-101 vs. Placebo for Adults Being Treated With Robotic Transcranial Magnetic Stimulation for Treatment Resistant Depression: The SPARC-TMS Trial Neuronavigated robotic-enabled TMS, NRX-101, Sham TMS - Treatment Resistant Depression, Treatment Resistant Depression (TRD) | Phase 2 / Phase 3 | Recruiting | NeuroRx, Inc. | 240 | 2026-12-01 | 2026-10-21 |
| Single Day of Ultra-accelerated TMS With a Single Dose of NRX-101 TMS, NRX-101 - Major Depression | Early Phase 1 | Not yet recruiting | Mclean Hospital | 30 | 2026-09-01 | 2026-09-22 |
| NRX-101 for Bipolar Depression With Subacute Suicidal Ideation NRX-101, Lurasidone HCl - Bipolar Depression, Suicidal Ideation and Behavior | Phase 2 / Phase 3 | Completed | NeuroRx, Inc. | 74 | 2022-05-12 | 2024-05-08 |
| NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation NRX-101, Lurasidone HCl - Bipolar Depression, Suicidal Ideation | Phase 3 | Unknown | NeuroRx, Inc. | 72 | 2019-12-01 | 2024-01-19 |
| NRX101 Glx Biomarker Validation Study NRX-101, Lurasidone HCl, Placebo - Bipolar Depression, Suicidal Ideation | Phase 2 / Phase 3 | Completed | NeuroRx, Inc. | 8 | 2018-11-01 | 2022-08-09 |
| NRX-101 Expanded Access NRX-101, Transcranial Magnetic Stimulation Sham - Treatment-Resistant Depression | Available | NeuroRx, Inc. | 2026-09-17 |
Bipolar Disorder (3) · Suicidal Ideation (3) · Depression (2) · Depressive Disorder, Treatment-Resistant (2) · Behavior (1) · Depressive Disorder, Major (1)
NeuroRx, Inc. (5) · Mclean Hospital (1)
United States (6)
Jonathan C Javitt, MD, MPH (2) · Martin Brecher, MD (2) · Andrew A Nierenberg, MD (1) · Jonathan Javitt, MD, MPH (1) · Joshua Brown, MD, PhD (1) · Joshua T Kantrowicz, MD (1) · Kerry Ressler, MD, PhD (1)
PMID 16677714, PMID 26364274, PMID 32785636, PMID 34149476, PMID 34711062, PMID 37815563, PMID 39714786