Study of Efficacy and Safety of MIJ821 in Addition to Comprehensive Standard of Care on the Rapid Reduction of Symptoms of Major Depressive Disorder in Subjects Who Have Suicidal Ideation With Intent

PHASE2TerminatedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

July 20, 2021

Primary Completion Date

September 26, 2023

Study Completion Date

September 26, 2023

Conditions
Major Depressive Disorder With Suicidal Ideation With Intent
Interventions
DRUG

MIJ821 Intravenous Injection

MIJ821 supplied in vials to be prepared on a mg/kg basis and to be administered for 40 minutes IV infusion on Day 1, Day 15 and Day 29

DRUG

Placebo Intravenous Injection

40 minutes IV infusion of 0.9% sodium chloride solution on Day1, Day 15 and Day 29

Trial Locations (39)

10048

Novartis Investigative Site, Taipei

11217

Novartis Investigative Site, Taipei

16059

Novartis Investigative Site, Bursa

20850

Novartis Investigative Site, Rockville

30331

Novartis Investigative Site, Atlanta

33334

Novartis Investigative Site, Oakland Park

34098

Novartis Investigative Site, Istanbul

35100

Novartis Investigative Site, Izmir

59100

Novartis Investigative Site, Kuala Lumpur

60590

Novartis Investigative Site, Frankfurt

64460

Novartis Investigative Site, Monterrey

70300

Novartis Investigative Site, Seremban

75115

Novartis Investigative Site, DeSoto

78213

Novartis Investigative Site, San Luis Potosí City

81377

Novartis Investigative Site, München

82140

Novartis Investigative Site, Mazatlán

107258

Novartis Investigative Site, Moscow

115419

Novartis Investigative Site, Moscow

35294-3300

Novartis Investigative Site, Birmingham

06030-3100

Novartis Investigative Site, Farmington

C1429DUC

Novartis Investigative Site, Buenos Aires

60430-270

Novartis Investigative Site, Fortaleza

09726-150

Novartis Investigative Site, São Bernardo do Campo

M5B 1W8

Novartis Investigative Site, Toronto

470-1168

Novartis Investigative Site, Toyoake

113-8519

Novartis Investigative Site, Bunkyo-ku

187-8551

Novartis Investigative Site, Kodaira

9713 GZ

Novartis Investigative Site, Groningen

05-802

Novartis Investigative Site, Pruszków

15 276

Novartis Investigative Site, Bialystok

80 952

Novartis Investigative Site, Gdansk

86-100

Novartis Investigative Site, Swiecie n/W

91-229

Novartis Investigative Site, Lodz

07120

Novartis Investigative Site, Palma de Mallorca

01004

Novartis Investigative Site, Vitoria-Gasteiz

08003

Novartis Investigative Site, Barcelona

08035

Novartis Investigative Site, Barcelona

08025

Novartis Investigative Site, Barcelona

08041

Novartis Investigative Site, Barcelona

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY