NRX101 Glx Biomarker Validation Study

Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. 18 to 65 years of age, inclusive, at screening. 2. Able to understand and provide written and dated informed consent prior to screening. Deemed likely to comply with study protocol and communicate AEs and other clinically important information, and agree to be hospitalized to complete screening and initiate experimental treatment. 3. Resides in a stable living situation, in the opinion of the investigator 4. Has an identified reliable informant, in the opinion of the investigator 5. Diagnosed with bipolar disorder (BD) according to the criteria defined in the DSM-5. The diagnosis of BD will be made by a psychiatrist and supported by the MINI 7.0.2. 6. Suicidal ideation or behavior as evidenced by an answer of "Yes" to item 2 or item 3 on the C-SSRS. 7. A score of greater than or equal to 20 on the MADRS. 8. In good general health, as ascertained by medical history, physical examination (including measurement of seated vital signs), clinical laboratory evaluations, and electrocardiogram 9. If female, a status of non-childbearing potential or use of an acceptable form of birth control per the following specific criteria: 1. Non-childbearing potential (e.g., 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 2. Childbearing potential, and meets the following criteria: i. Using any form of hormonal birth control, on hormone replacement therapy started prior to 12 months of amenorrhea, using an intrauterine device (IUD), having a monogamous relationship with a partner who has had a vasectomy, or sexually abstinent. ii. Negative urinary pregnancy test at screening, confirmed by a second negative urinary pregnancy test at randomization prior to receiving study treatment. iii. Willing and able to continuously use one of the following methods of birth control during the course of the study, defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly: implants, injectable or patch hormonal contraception, oral contraceptives, IUD, double-barrier contraception, sexual abstinence. The form of birth control will be documented at screening and pre-ketamine baseline. 10. Body mass index between 18-35kg/m2. 11. Concurrent psychotherapy will be allowed if the type and frequency of the therapy (e.g., weekly or monthly) has been stable for at least three months prior to screening and is expected to remain stable for the duration of the study. 12. Concurrent hypnotic therapy (e.g., with zolpidem, zaleplon, melatonin, benzodiazepines, or trazodone) will be allowed if the therapy has been stable for at least four weeks prior to screening and if it is expected to remain stable during the course of the subject's participation in the study. Subjects can also continue treatment with benzodiazepines used for anxiety if therapy has been stable for at least four weeks prior to screening and if it is expected to remain stable during the course of the subject's participation in the study. Exclusion Criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply: 1. Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study. 2. Female who is pregnant or breastfeeding. 3. Female with a positive pregnancy test at screening or before oral dosing of investigational product. 4. Current DSM-5 diagnosis of moderate or severe substance use disorder (except marijuana or tobacco use disorder) within the 12 months prior to screening. Substance abuse cannot be the precipitant of entry to treatment. 5. Subjects with a lifetime history of PCP/ketamine drug use, or failed use of ketamine for depression. 6. History of schizophrenia or schizoaffective disorder, or any history of psychotic symptoms when not in an acute bipolar mood episode. 7. History of anorexia nervosa, bulimia nervosa, or eating disorder NOS (OSFED) within five years of screening. 8. Has dementia, delirium, amnestic, or any other cognitive disorder. 9. Any major psychiatric disorder, including a personality disorder, which is clinically predominant to BD at screening, or has been the primary focus of treatment predominant to BD at any time within six months prior to screening. 10. Current major psychiatric disorder, diagnosed at screening with the MINI 7.0.2, that is the primary focus of treatment, with BD as the secondary focus of treatment, within the past six months. 11. A clinically significant abnormality on the screening physical examination that might affect safety or study participation, or that might confound interpretation of study results according to the study clinician. 12. Current episode of: 1. Untreated hypertension, (Stage 1 or greater) as defined by a systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg at screening on two of three measurements at least 15 minutes apart. If untreated due to missing medication dose/s this is not exclusionary. 2. Hypertension, Stage 2, as defined by a systolic blood pressure ≥155 mmHg or diastolic blood pressure ≥99 mmHg within 1.5 hours prior to ketamine infusion on two of three measurements at least 15 minutes apart at the pre-ketamine assessment (on Day 0 at Visit 1). 3. Recent myocardial infarction (within one year). 4. Syncopal event within the past year. 5. Congestive heart failure (CHF) New York Heart Association Criteria \>Stage 2. 6. Angina pectoris. 7. Heart rate \<50 or \>105 beats per minute at screening, pre-ketamine infusion (Day 0) or at randomization (Day 1). 8. QTcF ≥450 msec at screening for men, ≥ 470 msec for women, pre-ketamine infusion (Day 0), or at randomization (Day 1), on two of th…

Reproduced word-for-word from the public registry record — the study team can answer questions about it.