Sequential Therapy for the Treatment of Severe Bipolar Depression.

Completed · Phase 2 · Has a placebo group

Conditions studied: Bipolar Depression, Suicidal Ideas, Suicidal Ideation, Suicide, Attempted

In brief

NeuroRx is developing NRX-101, a fixed-dose combination oral capsule composed of d-cycloserine (DCS) and lurasidone for the maintenance of remission from Severe Bipolar Depression with Acute Suicidal Ideation (C-SSRS level 4 or 5) or Behavior (ASIB) in following initial stabilization. Patients with Severe Bipolar Depression and ASIB will be recruited in both inpatient and outpatient settings and, following informed consent, will be given an intravenous infusion of ketamine 0.5mg/kg over 40 minutes. Those who exhibit a satisfactory clinical response to ketamine will be randomly allocated to NRX-101 or to lurasidone alone (the comparator group). This study is conducted as a feasibility study for a pivotal phase 2b/3 clinical trial and the primary outcomes for this phase 2 study were blood levels of NRX-101, in order to confirm pharmaco-kinetics with remission from depression, as measured by BISS-derived MADRS and relapse as secondary outcomes.

Key facts

Study ID

NCT02974010

Run by

NeuroRx, Inc.

People needed

22

Starts

2018-01-15

Expected to finish

2019-11-20

Last updated by the study team

2021-05-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• A subject will not be eligible for inclusion in this study if any of the following criteria apply:
• Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
• Female that is pregnant or breastfeeding.
• Female with a positive pregnancy test at screening or baseline.
• Current diagnosis of a substance use disorder (abuse or dependence, as defined by DSM-5, with the exception of nicotine dependence), at screening or within 6 months prior to screening.
• Current Axis I disorder, diagnosed at screening with the use of the MINI 7.0.2, that is the primary focus of treatment and BD the secondary focus of treatment for the past 6 months or more.
• History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms.
• History of anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified, within 5 years of screening.
• Any Axis I or Axis II Disorder, which at screening is clinically predominant to their BD or has been predominant to their BD at any time within 6 months prior to screening.
• Has dementia, delirium, amnestic, or any other cognitive disorder.
• Has a clinically significant abnormality on the screening physical examination that might affect safety, study participation, or confound interpretation of study results according to the study clinician.
• Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation.
• Current episode of:
• Hypertension, Stage 1 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.
• Hypertension, Stage 1 as defined by a systolic blood pressure ≥155 mmHg or diastolic blood pressure ≥99 mmHg at the Baseline Visit (Visit 1) within 1.5 hours prior to ketamine infusion on two of three measurements at least 15 minutes apart.
• Recent myocardial infarction (within one year) or a history of myocardial infarction.
• Syncopal event within the past year.
• Congestive heart failure (CHF) New York Heart Association Criteria >Stage 2
• Angina pectoris.
• Heart rate <50 or >105 beats per minute at screening or randomization (Baseline Visit).
• QTcF (Fridericia-corrected) ≥450 msec at screening or randomization (Baseline Visit).
• Current history of hypertension, or on antihypertensives for the purpose of lowering blood pressure, with either an increase in antihypertensive dose or increase in the number of antihypertensive drugs used to treat hypertension over the last 2 months.
• Chronic lung disease excluding asthma.
• Lifetime history of surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative central nervous system (CNS) disorder (e.g., Alzheimer's or Parkinson's Disease), epilepsy, mental retardation, or any other disease/procedure/accident/intervention which, according to the screening clinician, is deemed associated with significant injury to or malfunction of the CNS, or history of significant head trauma within the past 2 years.
• Presents with any of the following lab abnormalities:

Where it is running

• Research Site, Birmingham — Birmingham, Alabama, United States
• Research Site, Fort Lauderdale — Fort Lauderdale, Florida, United States
• Research Site, Charlotte — Charlotte, North Carolina, United States
• Research Site, Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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