NRX-101 Expanded Access
ConditionTreatment-Resistant Depression
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorNeuroRx, Inc.
About this trial
The purpose of this Expanded Access Treatment Protocol is to make NRX-101 available to patients who have treatment-resistant depression and who are unable to participate in, or do not have access to, the ongoing NRX-101 clinical trial. The objective of the program is to provide treatment access while monitoring safety in the context of NRX-101 administration paired with theta burst transcranial magnetic stimulation..
Eligibility criteria
Qualifiers
18 years of age or older
Able to understand the study procedures and risks and able to provide written and dated informed consent before any protocol-specific procedure.
In the investigator's judgment, likely to comply with the Expanded Access Protocol, including transcranial magnetic stimulation visits, NRX-101 dosing instructions, scheduled assessments, and prompt communication of adverse events and other clinically important information.
Under the care of a board-certified psychiatrist or other qualified psychiatric prescriber who has completed protocol-specific training, is registered as an investigator for this Expanded Access Protocol, and agrees to direct and document the patient's psychiatric care according to standard of care.
Disqualifiers
Heterosexual female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
Female who is pregnant (positive pregnancy test at Screening) or breastfeeding.
Active suicidality (without the intention to act) as evidenced by a score of >3 on the Columbia Suicide Severity Rating Scale.
Current DSM-5 diagnosis of moderate or severe substance use disorder (except marijuana or tobacco use disorder) within the 12 months prior to Screening. (Note: Substance use disorder cannot be the precipitant for study entry).
Trial design
Treatments tested in this trial
- NRX-101
- Transcranial Magnetic Stimulation Sham
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov