Last reviewed · How we verify
NCT05779267: NRX-101EAP
NRX-101 Expanded Access
trial testing NRX-101 in Bipolar Depression. Available.
Quick facts
| Lead sponsor | NeuroRx, Inc. |
|---|---|
| Status | AVAILABLE |
| Study type | EXPANDED_ACCESS |
Drugs / interventions tested
- NRX-101
Conditions studied
- Bipolar Depression — all drugs for Bipolar Depression →
- Bipolar Affective Disorder — all drugs for Bipolar Affective Disorder →
Sponsor
NeuroRx, Inc. — full company profile →
Who can join
Adults 18 to 64, any sex, with Bipolar Depression or Bipolar Affective Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
There is no currently-approved pharmacotherapy for patients with Treatment-Resistant Bipolar Depression and Suicidal Ideation or behavior. The purpose of this Expanded Access Treatment Protocol is to make NRX-101 available to patients who have depression and suicidal ideation despite treatment with currently approved medication and to gather information on safety and efficacy in a real-world data environment. Participants will be treated by their own practicing psychiatrist and will agree to periodic psychometric evaluations to assess depression, suicidal ideation, and side effects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05779267
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of NRX-101
Trials testing the same drug.
- NCT07227103 — A Randomized, Double-Blind Controlled Comparison of NRX-101 vs. Placebo for Adults Being Treated With Transcranial Magne · Phase 2, PHASE3 · not yet recruiting
- NCT03395392 — NRX-101 for Bipolar Depression With Subacute Suicidal Ideation · Phase 2, PHASE3 · completed
- NCT03396068 — NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation · Phase 3 · unknown
- NCT03402152 — NRX101 Glx Biomarker Validation Study · Phase 2, PHASE3 · completed
Other recruiting trials for Bipolar Depression
Currently open trials in the same condition.
- NCT07266545 — RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE) · Phase 4 · recruiting
- NCT07246044 — HD-tDCS for Adolescent Bipolar Depression Targeting S1 · NA · recruiting
- NCT07121894 — Ketogenic Intervention for Bipolar Depression · NA · recruiting
- NCT07108257 — Magnetic Resonance-Guided Focused Ultrasound Bilateral Capsulotomy for the Treatment of Refractory Bipolar Depression · NA · recruiting
- NCT05603104 — Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First- · Phase 3 · recruiting
Other NeuroRx, Inc. trials
Trials by the same sponsor.
- NCT07227103 — A Randomized, Double-Blind Controlled Comparison of NRX-101 vs. Placebo for Adults Being Treated With Transcranial Magne · Phase 2, PHASE3 · not yet recruiting
- NCT06128213 — NRX-101 for Complicated Urinary Tract Infection (UTI) Including Pyelonephritis · Phase 2 · unknown
- NCT03395392 — NRX-101 for Bipolar Depression With Subacute Suicidal Ideation · Phase 2, PHASE3 · completed
- NCT04990466 — Phase 2b/3 Trial of VSV-ΔG SARS-CoV-2 Vaccine (BRILIFE) Against Approved Comparator Vaccine. · Phase 2, PHASE3 · withdrawn
- NCT03396068 — NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation · Phase 3 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05779267 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by NeuroRx, Inc.
- Last refreshed: 24 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05779267.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing