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.
Country United States of America
Visit trial
Status
Completed
Results Published
No
Start date
15 January 2018
End date
20 November 2019
Chance of happening
100%
Phase
Phase II
Design
Blinded
Type
Interventional
Generation
Second
Participants
22
Sex
All
Age
18- 65
Therapy
No
Trial Details
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).NCT Number NCT02974010
Sponsors & Collaborators
Massachusetts General HospitalMassachusettes General Hospital has launched the MGH Center for the Neuroscience of Psychedelics. The announcement has now been done via YouTube, and the formal launch will be in fall 2020.
Target Health
This company doesn't have a full profile yet, it is linked to a clinical trial.
Measures Used
Montgomery-Asberg Depression Rating ScaleA ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.