Long-term Safety & Efficacy Study of IN Esketamine in TRD (SUSTAIN-2)
Research type
Research Study
Full title
An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression (SUSTAIN-2)
IRAS ID
181955
Contact name
Allan Young
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2014-004587-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 13 days
Research summary
This is an open-label long-term study to evaluate the safety and efficacy of intranasal esketamine plus a newly initiated oral antidepressant in subjects with treatment-resistant depression (TRD) with special attention given to but not limited to: potential effects on cognitive function, potential withdrawal and/or rebound symptoms following cessation of intranasal esketamine treatment, long term efficacy including effects on depressive symptoms (clinician and self-reported), overall severity of depressive illness, functional impairment and associated disability, anxiety symptoms, and health-related quality of life and health status, response rate over time and remission rate over time. Approximately 750 adult patients with TRD (as defined as having a non-response to 2 or more oral antidepressants in the current episode at time of screening) will be enrolled globally with at least 100 subjects being 65yrs or older. The maximum duration of the subject’s participation in ESKETINTRD3004 study will be 60 weeks for direct-entry subjects; 56 weeks for transferred-entry non-responder subjects, and 52 weeks for transferred-entry responder subjects. Transferred-entry subjects refer to those subjects who completed the ESKETINTRD3005, a short-term efficacy study in elderly subjects with TRD. Subjects will be required to attend their trial site at set time points thoughout the study to complete a number of study specific asssessments including but not limited to: dosing of intranasal esketamine (28mg, 56mg or 84mg), physical and vital signs examination by their study doctor, multiple patient reported outcome questionnaires, blood collections for analysis, clinical interviews, ECG and through out the entire study subjects will be required to maintain a diary for compliance of their oral antidepressants.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
15/SC/0434
Date of REC Opinion
21 Sep 2015
REC opinion
Further Information Favourable Opinion