NRX-101 Expanded Access

NCT05779267 | Unknown

• 1 other identifier: NRX-101_006 EAP
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bipolar Depression; Bipolar Affective Disorder

Keywords

bipolar depression; suicidal ideation; cycloserine; NMDA antagonist; NRX-101

Interventions

NRX-101 DRUG

D-cycloserine/lurasidone fixed dose combination

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Age Groups: Adult (18-64)

You may qualify if:

• to 65 years of age, inclusive, at Screening
• Able to understand and provide written and dated informed consent prior to screening
• Deemed likely to comply with the study protocol, including communication of adverse events (AEs) and other clinically important information, including adherence to the text messaging component of the trial.
• Will follow medical directions for psychiatric care, as appropriate, per the standard of care.
• Resides in a stable living situation. A stable living situation will be defined as a minimum of 3 months at the same address with a reasonable expectation that the situation will continue such that the patient's ability to participate in the study will not be affected. Please note that housing in a shelter of any kind will not be deemed stable housing.
• Must have been under the care of a licensed qualified psychiatric prescriber for a minimum of 6 months prior to screening and be able and willing to provide documentation of treatment history and current and past psychiatric medication.
• Has an identified reliable informant/care partner, that is willing to provide information and/or supportive care as necessary.
• Diagnosed with bipolar disorder (BD) I or II according to the criteria defined in the DSM-5. The diagnosis of BD will be made by a psychiatrist or other qualified licensed psychiatric provider able to render a diagnosis and be supported by the MINI 7.0.2.
• Confirmed active suicidal ideation (without the intention to act) as evidenced by an answer of 'Yes' on item 3 and/or 4 and not requiring hospitalization at Screening and an answer of 'No' on item 5 of the C-SSRS within 4-weeks of Screening
• A total score greater than or equal to 20 on the 10 items of the MADRS
• No co-morbidities, as ascertained by medical history clinical laboratory evaluations, and electrocardiogram (ECG) which might interfere with compliance or the ability to assess efficacy or safety.
• If 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 study participation:
• 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:
• i. 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.

You may not qualify if:

• \. 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 or breastfeeding. 3. Female with a positive pregnancy test at Screening or prior to randomization.
• \. Current DSM-5 diagnosis of moderate or severe substance use or abuse disorder or a diagnosis of dependence (except marijuana or tobacco use disorder only) within the 12 months prior to Screening. (Note: Substance abuse cannot be the precipitant for study entry.) 5. A lifetime history of
• phencyclidine (PCP)/ketamine drug abuse, or
• failed use of ketamine for depression or suicidality. 6. History of schizophrenia or schizoaffective disorder, or any history of psychotic symptoms when not in an acute bipolar mood episode.
• \. History of anorexia nervosa, bulimia nervosa, eating disorder not otherwise specified (NOS), or other specified feeding and eating disorders (OSFED) within 5 years of Screening.
• \. Has dementia, delirium, amnestic, or any other cognitive disorder. 9. Current major psychiatric disorder, diagnosed at Screening with the MINI 7.0.2 which is the primary focus of treatment, with bipolar disorder as the secondary focus of treatment, within the past 6 months.
• \. Estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73 m2 using the Cockcroft-Gault formula 11. 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.
• \. Current episode of:
• a. Myocardial infarction within 1 year of Screening. b. Diagnosis of angina pectoris. c. 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. 14. Lifetime history of any of the following: surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative central nervous system (CNS) disorder (e.g., Alzheimer's Disease, Parkinson's Disease), epilepsy, mental retardation, 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 significant head trauma within the past two years. 16. Diabetes mellitus fulfilling any of the following criteria:
• Unstable diabetes mellitus defined as glycosylated hemoglobin (HbA1c) \>8.0 % 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.

Sponsors & Collaborators

• NeuroRx, Inc.: lead
• Prevail Infoworks: collaborator

Related Links

• NRX-101 (D-cycloserine plus lurasidone) vs. lurasidone for the maintenance of initial stabilization after ketamine in patients with severe bipolar depression with acute suicidal ideation and behavior: A randomized prospective phase 2 trial

MeSH Terms

Conditions

Bipolar Disorder; Suicidal Ideation

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Jonathan C Javitt, MD, MPH

  NRx Pharmaceuticals

  PRINCIPAL INVESTIGATOR

• Martin Brecher, MD

  NRx Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Heather Lothamer, RN, PhD

CONTACT

484-268-1624; hlothamer@nrxpharma.com

Marisa Gorovitz, MSW

CONTACT

484-268-1656; mgorovitz@nrxpharma.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 22, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03