Sequential Therapy for the Treatment of Severe Bipolar Depression

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.

Topic Bipolar Disorder Suicidality Depression
Compound Placebo Ketamine
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 Hospital
Massachusettes 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 Scale
A ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.

Data attribution

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