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Treatment-Resistant DepressionNRX-101 EAPNCT05779267

NRX-101 Expanded Access

A study testing NRX-101 in people with Treatment-Resistant Depression, run by NeuroRx, Inc. at 1 site in United States.

Available

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Treatment-Resistant Depression
What is being tested?
NRX-101
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
Not given
Where
1 siteUnited States
Study dates
Start not givento not given
Phase
Expanded access
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Who may be able to join

  • -
  • Eligible for inclusion in this EAP only if all the following criteria apply:
  • 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.
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  • 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.
  • If heterosexual female, a status of non-childbearing potential or use of an acceptable form of birth control per the following criteria, and agrees to continue use of the same method of birth control for the duration of treatment with NRX-101:
  • Non-childbearing potential: physiologically incapable of becoming pregnant (i.e., permanently sterilized [status post-hysterectomy, bilateral tubal ligation], or post-menopausal with last menses at least one year prior to Screening); or
  • Childbearing potential, and meets the following criteria:
  • Use of any form of hormonal birth control for at least 2 months prior to Screening, on hormone replacement therapy that started prior to 12 months of amenorrhea, using an intrauterine device (IUD) for at least 1 month prior to Screening, in a monogamous relationship with a partner who has had a vasectomy, or sexually abstinent.
  • Negative urinary pregnancy test at Screening, confirmed by a second negative urinary pregnancy test at Day 1, prior to receiving treatment with NRX-101.
  • Sufficient stability of residence and contact information to allow appropriate follow up and emergency contact during participation in the Expanded Access Protocol, in the investigator's judgment.
  • The patient is not participating in and cannot reasonably enroll in the concurrent Phase IIb trial NRX101-011, because the patient does not meet at least one inclusion criterion for NRX101-011, meets at least one exclusion criterion for NRX101-011, or faces distance, transportation, schedule, or other practical barriers that prevent trial participation despite interest. The investigator must document the specific reason in the source record.

Who cannot join

  • 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).
  • Current DSM-5 diagnosis of alcohol use disorder
  • A lifetime history of phencyclidine (PCP)/ketamine drug abuse
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  • History of schizophrenia or schizoaffective disorder
  • History of anorexia nervosa, bulimia nervosa, eating disorder not otherwise specified (NOS), or other specified feeding and eating disorders (OSFED) within 3 years of Screening.
  • Has dementia, delirium, amnestic, or any other cognitive disorder.
  • Renal impairment defined as estimated glomerular filtration rate (eGFR) < 60 mL/min, calculated using the 2021 CKD-EPI creatinine equation (race-free).
  • Clinically significant hepatic impairment. Clinically significant hepatic impairment is defined as a history of chronic liver disease (e.g., cirrhosis, chronic hepatitis, alcoholic liver disease, nonalcoholic steatohepatitis) or evidence at Screening of acute liver disease or impaired liver function (e.g., ALT or AST >3 × ULN, total bilirubin >2 × ULN) or in the opinion of the Investigator.
  • A clinically significant abnormality on the Screening physical examination that may affect safety or study participation, or that may confound interpretation of study results according to the study clinician.
  • Risk factors for neurocardiogenic syncope including history of syncope/ presyncope related to noxious stimuli, anxiety, micturation, or posture.
  • Co-morbidities as ascertained by medical history, physical examination (including measurement of vital signs), clinical laboratory evaluations, and electrocardiogram (ECG) which might interfere with compliance or the ability to assess efficacy or safety.
  • Diagnosis of moderate to severe heart disease or current episode of:
  • Myocardial infarction within 1 year of Screening.
  • Diagnosis of angina pectoris.
  • Prolonged QTc interval, as measured by Fridericia's correction formula (QTcF) ≥450 msec at Screening for males or ≥ 470 msec for females on 2 of 3 measurements at least 15 minutes apart prior to randomization on Day 1.
  • Diagnosis of chronic lung disease, excluding asthma.
  • Lifetime history of any of the following: neurologic conditions with structural cerebral damage, traumatic brain injury, multiple sclerosis, surgical procedures involving the brain or meninges, meningoencephalitis, degenerative central nervous system (CNS) disorder (e.g., Alzheimer's Disease, Parkinson's Disease), mental retardation, stroke (ischemic or hemorrhagic), intracranial abscess, or any other disease/procedure/accident/intervention that, according to the clinician, is deemed associated with significant injury to, or malfunction of, the CNS.
  • History of epilepsy, personal history of seizure, family history of epilepsy or seizure in a first degree relative.
  • Diagnosis of parenchymal or leptomeningeal cancer.
  • Diabetes mellitus fulfilling any of the following criteria:
  • Unstable diabetes mellitus defined as glycosylated hemoglobin (HbA1c) >8.0 percent at Screening.
  • Admitted to the hospital for treatment of diabetes mellitus or diabetes mellitus-related illness in the past 12 weeks.
  • Not under physician care for diabetes mellitus.
  • Not on the same dose of oral hypoglycemic drug(s) and/or diet for the 4 weeks prior to Screening.
  • Not on the same dose of oral thiazolidinediones (glitazones) for the 8 weeks prior to Screening.
  • Any current or past history of any physical condition which, in the opinion of the investigator, may put the patient at risk or interfere with study results interpretation.
  • On exclusionary concomitant psychotropic and non-psychotropic medications (see Section 9.5)
  • Prescribed more than one agent in each of the following categories at randomization:
  • Approved SSRIs.
  • Approved serotonin and norepinephrine reuptake inhibitors (SNRIs).
  • Approved tetracyclic antidepressants (TeCAs).
  • Currently prescribed oxcarbazepine or carbamazepine.
  • Exclusionary laboratory values or any other clinically significant abnormal laboratory result at Screening. Within normal limits (WNL) will be determined based on lab values of the local lab used.
  • Known allergies to lurasidone or Latuda®, cycloserine or Seromycin®, or the following excipients: mannitol, croscarmellose sodium, magnesium stearate, silicon dioxide, and/or hydroxypropylmethylcellulose (HPMC).
  • Participation in any clinical trial with an investigational drug or device within the past 3 months or planned concurrent study participation.
  • Study site personnel and/or persons employed by NRx Pharma, Inc., the Contract Research Organization (CRO), the investigator, or study site (i.e., permanent, temporary contract worker, or designee responsible for the conduct of the study), or an immediate family member (i.e., spouse, parent, child, or sibling [biological or legally adopted]) of such persons.
  • Positive urine toxicity screening for use of any cocaine, opiates, non-prescribed amphetamines, or non-prescribed barbiturates. (Note: cannabinoids or marijuana use is not exclusionary, unless patient meets the DSM-5 criteria for cannabis withdrawal).
  • Patients with pacemakers and/or any implants including metal in the head except the mouth (cochlear implant, implanted brain stimulators, aneurysm clips)
  • Individuals with an intracranial lesion or increased intracranial pressure

Trial locations and contacts

1 site in 1 country.

Rebecca Boone contact

919-280-2857

rboone@nrxdefense.com

Jeff Heckman, MBA contact

4848020087

jheckman@nrxpharma.com

United States1 site

  • Harvard Mclean Hospital

    Belmont, Massachusetts, 02478

    Kerry Ressler, MD, 617-855-4210, kressler@mclean.harvard.edu

    Available

Other trials in United States

About this study

Official title: NRX-101 for Treatment-Resistant Depression in Patients Receiving Transcranial Magnetic Stimulation Who Do Not Qualify for NRX101-011 (MIND1): Expanded Access Program

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..

Read the detailed description

This Expanded Access Protocol is intended for patients with treatment-resistant depression with or without suicidal ideation, conditions that are serious and potentially life-threatening. Many patients in this population do not achieve adequate benefit from currently approved pharmacologic and nonpharmacologic treatments and therefore lack satisfactory therapeutic alternatives. Available clinical and mechanistic data for NRX-101 suggest a potential for clinically meaningful benefit when administered in conjunction with TMS, and the anticipated benefits are considered to justify the potential risks in this population. Access under this program is limited to patients who are not eligible for, or cannot reasonably participate in, the ongoing clinical trial (NRX101-011), or enrollment is capped, such that this program will not interfere with the initiation, conduct, or completion of the clinical development program.

Being tested
NRX-101, Transcranial Magnetic Stimulation Sham
Keywords
cycloserine, NMDA antagonist, NRX-101, transcranial magnetic stimulation
Medical subject headings
Depressive Disorder, Treatment-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NRX-101Drug

    D-cycloserine/lurasidone fixed dose combination

  • Transcranial Magnetic Stimulation ShamDevice

    transcranial magnetic stimulation will be employed and has shown effect in this population

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT05779267
Sponsor's protocol ID
NRX101-012 EAP
Acronym
NRX-101 EAP
Status last verified
Sep 2026
First submitted
8 Mar 2023
Last updated
17 Sep 2026
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing NRX-101 in people with Treatment-Resistant Depression, run by NeuroRx, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rebecca Boone (919-280-2857, rboone@nrxdefense.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05779267.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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