Trial of Intranasal Esketamine for Treatment of Depression SUSTAIN-3
Research type
Research Study
Full title
An Open-label Long-term Extension Safety Study of Intranasal Esketamine in Treatment-resistant Depression Safety and Sustenance of Esketamine Treatment Response With Repeated Doses at Intervals Determined by Symptom Severity (SUSTAIN-3)
IRAS ID
212314
Contact name
Sofia Ganzha
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2015-003578-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 7 months, 10 days
Research summary
This is a study that going to be using multiple hospitals/ clinics internationally for this research. The study is called ‘open label’ which means both doctor and patient know the assigned treatment. This study will provide Intranasal Esketamine as long-term extension study to male and female patients with Treatment-Resistant Depression (TRD) who previously took part in ESKETINTRD3004 or/ and ESKETINTRD3005 studies and responded to Esketamine, or doctor believes would benefit from continuous treatment of Esketamine. By Treatment-Resistant Depression meant depression that has not been helped by several antidepressant treatments. The main purpose of this study is to assess the long-term safety and tolerability (how well a patient will tolerate), of Esketamine nasal spray.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
16/SC/0435
Date of REC Opinion
7 Sep 2016
REC opinion
Favourable Opinion