Trial of Intranasal Esketamine for Treatment of Depression TRANSFORM-3
Research type
Research Study
Full title
A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Subjects with Treatment-resistant Depression
IRAS ID
181387
Contact name
Frank De Beukelaar
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2014-004588-19
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 8 months, 27 days
Research summary
This is a randomised (study drug is assigned by chance), double-blind (neither the doctor or the patient know the assigned treatment), active-controlled (compared to established treatments), multi-centre study in male and female elderly subjects with Treatment-Resistant Depression (TRD) to assess the efficacy, safety, and tolerability of flexibly dosed intranasal Esketamine (28mg, 56mg or 84mg) plus a newly initiated oral antidepressant (OAD), compared with a newly initiated OAD (active comparator) plus intranasal placebo. Phase 1-Screening/Observational phase (4-week duration) - response to the patients' current OAD will be assessed. Patients who are not responding (as assessed by independent, remote raters) may be eligible to proceed to Phase 2.
Phase 2 - Double-blind (DB) induction phase - eligible patients will discontinue their current OAD(s) over a period of up to 3 weeks. Approximately 148 patients will be randomly assigned at a 1:1 (n=74 subjects per treatment arm) to receive DB intranasal treatment with either Esketamine (28mg, 56mg or 84mg) or placebo. The intranasal treatment sessions will occur twice weekly for 4 weeks. In addition, all patients will initiate a new, open label OAD on Day 1 (to be taken daily during this phase). The new OAD will be one of the following and will be assigned by the study doctor - duloxetine, escitalopram, sertraline, or venlafaxine XR. At the end of the DB induction phase, regardless of response status, patients may be eligible to participate in the subsequent study ESKETINTRD3004 (a long term open-label safety study involving repeated treatment sessions of intranasal Esketamine).
Phase 3 - Follow up (2-week duration) - subjects not eligible for ESKETINTRD3004 will be provided a 2 week supply of OAD to cover the period of transition to further clinical/standard of care.
Study assessments include blood and urine testing, physical examinations, patient reported outcome interviews and questionnaire completion.REC name
South Central - Oxford A Research Ethics Committee
REC reference
15/SC/0432
Date of REC Opinion
21 Sep 2015
REC opinion
Further Information Favourable Opinion