Sequential Therapy for the Treatment of Severe Bipolar Depression.
Status:
Completed
Trial end date:
2019-11-20
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
NeuroRx, Inc.
Collaborators:
Massachusetts General Hospital PPD Target Health Inc.