A Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Participants With Treatment Resistant Depression

PHASE2CompletedINTERVENTIONAL
Enrollment

202

Participants

Timeline

Start Date

December 12, 2016

Primary Completion Date

August 19, 2019

Study Completion Date

December 13, 2019

Conditions
Depression
Interventions
DRUG

Placebo

Participant will receive 1 spray of placebo to each nostril at 0 minute, 5 minutes and 10 minutes.

DRUG

Intranasal esketamine (28 mg)

Participant will receive 1 spray of Esketamine to each nostril at 0 minute and placebo at 5 minutes and 10 minutes.

DRUG

Intranasal esketamine (56 mg)

Participant will receive 1 spray of Esketamine to each nostril at 0 minute, 5 minutes and placebo at 10 minutes.

DRUG

Intranasal esketamine (84 mg)

Participant will receive 1 spray of Esketamine to each nostril at 0 minute, 5 minutes and 10 minutes.

Trial Locations (43)

Unknown

Akita

Fukui-shi

Fukuoka

Gunma

Hachinohe-shi

Hachioji-shi

Hirakata

Hiratsuka-shi

Hokkaido

Ibaraki

Ichikawa

Kanzaki-gun

Karatsu

Kashihara

Kawasaki

Kita-Azumi

Kita-ku

Kitakyushu

Kobe

Kochi

Kodaira

Komoro-shi

Kumamoto

Kure

Kurume-shi

Kyoto

Maizuru

Morioka

Nagakute

Nagasaki

Okayama

Okinawa

Osaka

Sapporo

Setagaya-ku

Shibuya-ku

Shinjuku

Shinjuku-ku

Takatsuki-shi

Toyoake

Ube

Yokohama

Yonago

Sponsors
All Listed Sponsors
lead

Janssen Pharmaceutical K.K.

INDUSTRY