NRX-101 for Bipolar Depression With Subacute Suicidal Ideation
Public ClinicalTrials.gov record NCT03395392. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind Controlled Comparison of NRX-101 to Lurasidone for Adults With Bipolar Depression and Subacute Suicidal Ideation or Behavior
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03395392
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 74 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 12, 2022 (Actual)
- Primary completion
- Feb 28, 2024 (Actual)
- Completion
- Mar 30, 2024 (Actual)
- Last update posted
- May 8, 2024
2022 – 2024
United States locations
- U.S. sites
- 14
- U.S. states
- 8
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Science 37 | Culver City | California | 90320 | — |
| San Marcus Research Clinic, Inc. | Miami Lakes | Florida | 33014 | — |
| ACMR | Atlanta | Georgia | 30331 | — |
| iResearch Atlanta, LLC | Decatur | Georgia | 30030 | — |
| iResearch Savannah | Savannah | Georgia | 31405 | — |
| CBH Health | Gaithersburg | Maryland | 20877 | — |
| Omaha Insomnia and Psychiatric Services | Omaha | Nebraska | 68144 | — |
| Dent Neurologic Institute | Amherst | New York | 14226 | — |
| Peace Health Medical Group | Eugene | Oregon | 97401 | — |
| University of Texas Health Austin | Austin | Texas | 78712 | — |
| Roots Behavioral Health | Austin | Texas | 78746 | — |
| JPS Health | Fort Worth | Texas | 76104 | — |
| Houston Mind and Brain | Houston | Texas | 77055 | — |
| Health Texas | Richmond | Texas | 77407 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03395392, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 8, 2024 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03395392 live on ClinicalTrials.gov.