Sequential Therapy for the Treatment of Severe Bipolar Depression.

PHASE2CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

January 15, 2018

Primary Completion Date

August 31, 2018

Study Completion Date

November 20, 2019

Conditions
Bipolar DepressionSuicidal IdeasSuicidal IdeationSuicide, 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

Trial Locations (4)

28211

Research Site, Charlotte, Charlotte

33024

Research Site, Fort Lauderdale, Fort Lauderdale

35294

Research Site, Birmingham, Birmingham

77030

Research Site, Houston, Houston

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Massachusetts General Hospital

OTHER

collaborator

Target Health Inc.

INDUSTRY

lead

NeuroRx, Inc.

INDUSTRY