NRX-101 Expanded Access

Inclusion criteria

• . 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.
• . Diagnosed with treatment resistant depression (TRD) according to the criteria defined in the DSM-5. This diagnosis must be made by a psychiatrist or other qualified licensed psychiatric provider.
• . History of inadequate response, intolerance, or loss of effect to at least one prior adequate pharmacologic treatment for the current depressive episode with a medication indicated for treatment-resistant depression in the investigator's judgment.
• . Planned course of theta burst transcranial magnetic stimulation as part of standard clinical care for the current depressive episode, to be delivered at a site with appropriate experience and safety procedures for transcranial magnetic stimulation.
• . No uncontrolled or unstable medical condition that, in the investigator's judgment, creates an unacceptable risk with theta burst transcranial magnetic stimulation in combination with NRX-101 or prevents adequate assessment of safety.