The purpose of this study is to compare the efficacy and safety of switching treatment-resistant depression (TRD) subjects from a prior antidepressant treatment (to which they have not responded) to either intranasal esketamine plus a new oral antidepressant or switching to a new oral antidepressant plus intranasal placebo.
Country United States of America
Visit trial
Status
Completed
Results Published
Start date
07 August 2015
End date
06 November 2017
Chance of happening
100%
Phase
Phase III
Design
Blinded
Type
Interventional
Generation
Second
Participants
236
Sex
All
Age
18- 64
Therapy
No
Trial Details
This is a randomized, double-blind (neither the researchers nor the subjects know what treatment the subject is receiving), active-controlled, multicenter study (more than 1 study site) in subjects with TRD to assess the efficacy, safety, and tolerability of flexible doses of intranasal esketamine plus a newly initiated oral antidepressant compared with a newly initiated oral antidepressant (active comparator) plus intranasal placebo. The study will consist of 3 phases: Screening/Prospective Observational Phase (4-7 weeks), Double-blind Induction Phase (4-weeks), Follow-up Phase (24-weeks). Subjects who roll over into a long-term maintenance study will not participate in the Follow-up Phase. The antidepressant treatment, as well as any other ongoing medications being taken for depression at screening (including adjunctive/ augmentation therapies), will continue unchanged, at the same dosage, from the start of Week 1 through the end of Week 4 of the screening/prospective observational phase. Subjects' safety will be monitored throughout the study.NCT Number NCT02418585
Sponsors & Collaborators
Johnson & JohnsonOne of the largest pharmaceutical companies in the world, Johnson & Johnson are responsible for bringing esketamine to market in the form of Spravato.
Papers
Efficacy and safety of esketamine nasal spray by sex in patients with treatment-resistant depression: findings from short-term randomized, controlled trialsThis post hoc analysis of three RCTs using esketamine in patients with treatment-resistant depression (TRD) (n=721) found no sex differences when using esketamine for TRD. Across the three trials, it was found that the efficacy and overall safety of esketamine in patients with TRD were similar for both men and women. The most common adverse events in esketamine-treated patients were nausea, dissociation, dizziness, and vertigo, each reported at a rate higher in women than men.
Intranasal esketamine effectively treats treatment-resistant depression in adults regardless of baseline irritability
This post hoc analysis of two Phase III double-blind studies assessed the effects of baseline irritability on clinical outcomes in participants with treatment-resistant depression (TRD) (n=560) treated with intranasal ketamine (esketamine) plus an oral antidepressant (ESK + AD). ESK + AD improved symptoms of depression regardless of baseline irritability level and increased odds of achieving a response in all participants.
Evaluation of Individual Items of the Patient Health Questionnaire (PHQ-9) and Montgomery-Asberg Depression Rating Scale (MADRS) in Adults with Treatment-Resistant Depression Treated with Esketamine Nasal Spray Combined with a New Oral Antidepressant
This posthoc analysis of the TRANSFORM-2 trial assessed the effects of esketamine plus an oral antidepressant (AD) using the Patient Health Questionnaire (PHQ-9) and Montgomery-Asberg Depression Rating Scale (MADRS). The odds of improving in those treated with esketamine plus AD were at least two times greater than with placebo plus AD.