108
Participants
Start Date
January 27, 2014
Primary Completion Date
July 21, 2015
Study Completion Date
September 25, 2015
Esketamine 14 mg
1 to 6 sprays of esketamine 14 mg self-administered as an intranasal formulation for 4 days (Days 1, 4, 8, 11) during the double-blind phase and if applicable during the optional open-label phase for up to 4 days
Esketamine 28 mg
1 to 6 sprays of esketamine 28 mg self-administered as an intranasal formulation for 4 days (Days 1,4, 8, 11) during the double-blind phase and if applicable, during the optional open-label phase for up to 9 days
Esketamine 56 mg
1 to 6 sprays of esketamine 56 mg self-administered as an intranasal formulation for up to 4 days (Days 1, 4, 8, 11) during the double-blind phase and if applicable, during the optional open-label phase for up to 9 days
Esketamine 84 mg
1 to 6 sprays of esketamine 84 mg self-administered as an intranasal formulation for up to 4 days (Days 1, 4, 8, 11) during the double-blind phase and if applicable, during the optional open-label phase for up to 9 days
Placebo
1 to 6 sprays of placebo self-administered as an intranasal formulation for 2 days (Days 1 and 4) or depending on response on Day 8, for 4 days (Days 1,4, 8, 11) during the double-blind phase
Birmingham
Garden Grove
Hartford
Jacksonville
Tampa
Atlanta
Chicago
Hoffman Estates
Rockville
Cedarhurst
New York
Allentown
Philadelphia
Memphis
Lede
Akita
Hiroshima
Ichikawa
Kanzaki
Kashihara
Kitakyushu
Kodaira
Kumamoto
Nagano
Shibukawa
Janssen Research & Development, LLC
INDUSTRY