Sequential Therapy for the Treatment of Severe Bipolar Depression.

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.

Conditions

• Bipolar Depression
• Suicidal Ideas
• Suicidal Ideation
• Suicide, Attempted

Interventions

DRUG

NRX-101 Oral Capsule

Prospective Randomized Factorial Design Study as per arm/group descriptions

DRUG

Lurasidone Oral Capsule

Prospective Randomized Factorial Design Study as per arm/group descriptions

DRUG

Ketamine Intravenous Infusion

Randomized administration of Ketamine or Placebo in a 3 to 1 ratio

DRUG

Saline Solution Intravenous Infusion

Randomized administration of Ketamine or Placebo in a 3 to 1 ratio

Sponsors & Collaborators

• Massachusetts General Hospital

  collaborator OTHER

• Target Health Inc.

  collaborator INDUSTRY

• NeuroRx, Inc.

  lead INDUSTRY

Principal Investigators

• Andrew Nierenberg, MD · Massachusetts General Hospital

• Daniel C Javitt, MD · NeuroRx, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-15

Primary Completion

2018-08-31

Completion

2019-11-20

FDA Drug

Yes

Countries

• United States

Study Locations