A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression

PHASE3CompletedINTERVENTIONAL
Enrollment

1,148

Participants

Timeline

Start Date

June 9, 2016

Primary Completion Date

December 30, 2022

Study Completion Date

December 30, 2022

Conditions
Depressive Disorder, Treatment-Resistant
Interventions
DRUG

Esketamine Nasal Spray

Open-Label Induction Phase: Participants will self-administer with esketamine nasal spray twice per week for 4 weeks as a flexible dose regimen (56 milligram \[mg\] or 84 mg for those \< 65 years; 28 mg, 56 mg or 84 mg for those \>= 65 years). Participants \>= 65 years old will start at a dose of 28 mg on Day 1. Optimization/Maintenance Phase: Participants entering from studies ESKETINTRD3001 (NCT02417064), ESKETINTRD3002 (NCT02418585) or ESKETINTRD3006 (US sites only) will self-administer esketamine nasal spray (same dose) once weekly. Participants entering from study ESKETINTRD3005 (NCT02422186) will self-administer esketamine nasal spray (28 mg in week 1; 28 or 56 mg in week 2; and 28, 56 or 84 mg in week 3 and 4) once weekly. After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants can be adjusted based upon efficacy and tolerability.

Trial Locations (173)

Unknown

Birmingham

Little Rock

Garden Grove

Glendale

Oakland

Orange

San Diego

San Rafael

Hartford

New Haven

Gainesville

Miami

Orlando

Atlanta

Chicago

Hoffman Estates

Joliet

Maywood

Skokie

Iowa City

Wichita

Lake Charles

Shreveport

Baltimore

Gaithersburg

Boston

New Bedford

Watertown

Worcester

Rochester Hills

O'Fallon

Saint Charles

Omaha

Cedarhurst

New York

Staten Island

Hickory

Cincinnati

Oklahoma City

Allentown

Media

Philadelphia

Lincoln

Providence

Charleston

Austin

Dallas

Houston

Wichita Falls

Charlottesville

Waukesha

Banfield

Buenos Aires

Córdoba

La Plata

Mendoza

Rosario

Caulfield

Elizabeth Vale

Frankston

Vienna

Aalst

Bruges

Brussels

Heusden-Zolder

Liège

Yvoir

Belo Horizonte

Curitiba

Fortaleza

Passo Fundo

Porto Alegre

Recife

Rio de Janeiro

São Bernardo do Campo

São Paulo

Burgas

Kardzhali

Pazardzhik

Pleven

Plovdiv

Rousse

Sofia

Varna

Vancouver

Kingston

Ottawa

Toronto

Brno

Pilsen

Prague

Tallinn

Tartu

Kuopio

Clermont-Ferrand

Douai

Nantes

Nîmes

Paris

Poitiers

Toulon

Berlin

Bochum

Mainz

Mittweida

Oranienburg

Pfaffenhofen

Budapest

Debrecen

Győr

Pécs

Sopron

Szekszárd

Vác

Kaunas

Kuala Lumpur

Guadalajara

León

Mexico City

México

Monterrey

San Luis Potosí City

Bełchatów

Bialystok

Bydgoszcz

Gdansk

Leszno

Lublin

Warsaw

Bratislava

Liptovský Mikuláš

Rimavská Sobota

Rožňava

Svidník

Cape Town

Pretoria

Welgemoed

Gwangju

Seoul

Alcorcón

Barcelona

Bilbao

Madrid

Oviedo

Palma

Pamplona

Sabadell

Salamanca

Sant Boi de Llobregat

Torrevieja

Vitoria-Gasteiz

Zamora

Halmstad

Lund

Skövde

Stockholm

Kaohsiung City

New Taipei City

Taichung

Taipei

Taoyuan District

Adana

Ankara

Bursa

Istanbul

Kucukcekmece/Istanbul

Oanakkale

Samsun

Chesterfield

Derby

London

Northampton

Oxford

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02782104 - A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression | Biotech Hunter | Biotech Hunter