Sequential Therapy for the Treatment of Severe Bipolar Depression. (NCT02974010) | Clinical Trial Compass
CompletedPhase 2
Sequential Therapy for the Treatment of Severe Bipolar Depression.
United States22 participantsStarted 2018-01-15
Plain-language summary
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.
Who can participate
Age range18 Years ā 65 Years
SexALL
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Inclusion criteria
ā. Male or female, 18 to 65 years of age, inclusive, at screening.
ā. Able to read, understand, and provide written, dated informed consent prior to screening. Participants will be deemed likely to comply with study protocol and communicate with study personnel about AEs and other clinically important information.
ā. Diagnosed with Bipolar Disorder (BD) according to the criteria defined in the DSM-5. The diagnosis of BD will be made by a site psychiatrist and supported by the MINI 7.0.2. The diagnosis will be confirmed by remote, independent raters, via teleconference between the screen visit and the baseline visit.
ā. Suicidal ideation or behavior of sufficient severity to meet the requirements for a score of 4, or 5 on the C-SSRS (suicide attempt, interrupted attempt, aborted attempt, preparatory actions toward imminent suicidal behaviors, active method, intent +/- plan).
ā. A score equal to or greater than 20 on the MADRS items of the BISS.
ā. In good general health, in the opinion of the investigator, as ascertained by medical history, physical examination (PE) (including measurement of seated vital signs), clinical laboratory evaluations, and electrocardiogram (ECG).
ā. If female, a status of non-childbearing potential or use of an acceptable form of birth control per the following specific criteria:
What they're measuring
1
BDM Score (BISS-derived MADRS) Change From Baseline at Day 42
ā. Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
ā. Female that is pregnant or breastfeeding.
ā. Female with a positive pregnancy test at screening or baseline.
ā. 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.
ā. 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.
ā. History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms.
ā. History of anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified, within 5 years of screening.
ā. 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.