NRX-101 for Maintenance of Remission From Severe... — Clinical Trial Details

Participants

Ages

18 – 65

Sexes

Male & Female

BMI

18 - 35

Psychosis History

Inclusion Criteria

Inclusion Criteria:
A subject will be eligible for inclusion in this study based on successful response to infusion under NCT03396601 and the following criteria:
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. In good general health, as ascertained by medical history, physical examination (including measurement of seated vital signs), clinical laboratory evaluations, and electrocardiogram
7. If female, a status of non-childbearing potential or use of an acceptable form of birth control per the following specific criteria:
a. 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 b. 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.
8. Body mass index between 18-35kg/m2.
9. 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.
10. 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

Exclusion Criteria:
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 untreated hypertension, recent MI, syncopal event, CHF NYHA >Stage 2, angina, HR <50 or >105, or QTcF ≥450 ms (men) / ≥470 ms (women) on two of three measurements at specified times.
13. History of hypertension managed with recent medication changes.
14. Chronic lung disease, excluding asthma.
15. Lifetime history of neurosurgery, encephalitis/meningitis, degenerative CNS disorder, epilepsy, intellectual disability, or recent significant head trauma.
16. Significant lab abnormalities (including unstable diabetes as defined in protocol).
17. Any current or past physical condition that might put the subject at risk or interfere with study results.
18. Subjects on exclusionary concomitant psychotropic medications as defined in the protocol.

Company

Product

Legal

NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation

Detailed Description

Study Arms & Interventions

NRX-101

Interventions

Lurasidone

Locations

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators