A Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression

This Phase III trial (n=252) investigated the effect of esketamine (58-84mg, 8x) on treatment-resistant depression (TRD). Ultimately the trial didn’t find significant results at 28 days.

Topic Treatment-Resistant Depression Depression
Compound Ketamine
Country China United States of America
Visit trial
Status Completed
Results Published Yes
Start date 15 February 2018
End date 13 April 2021
Chance of happening 100%
Phase Phase III
Design Blinded
Type Interventional
Generation First
Participants 252
Sex All
Age 18- 64
Therapy No

Trial Details

The purpose of this study is to evaluate the efficacy of switching adult participants with treatment-resistant depression (TRD) from a prior antidepressant treatment (to which they have not responded) to flexibly dosed intranasal esketamine (56 milligram [mg] or 84 mg) plus a newly initiated oral antidepressant compared with switching to a newly initiated oral antidepressant (active comparator) plus intranasal placebo, in improving depressive symptoms. Efficacy will be assessed by the change from baseline in the Montgomery Asberg Depression Rating Scale (MADRS) total score from Day 1 (before randomization) to the end of the 4-week double-blind treatment phase.

NCT Number NCT03434041

Sponsors & Collaborators

Johnson & Johnson
One 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 Flexibly Dosed Esketamine Nasal Spray Plus a Newly Initiated Oral Antidepressant in Adult Patients with Treatment-Resistant Depression: A Randomized, Double-Blind, Multicenter, Active-Controlled Study Conducted in China and USA
This double-blind, randomized Phase III trial (n=227) finds no significant difference between esketamine plus a new antidepressant versus only the antidepressant (and a placebo) at day 28 on depression scores (MADRS). The study reports one death in the esketamine group. It also states esketamine to be "effective and safe" though only the first claim could be credibly made if one only looks at the immediate (24-hour) effects.

Data attribution

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