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

  • STATUS
    Recruiting
  • days left to enroll
    57
  • participants needed
    234
  • sponsor
    Janssen Research & Development, LLC
Updated on 9 May 2021
Investigator
The Medical Research Network, LLC
Primary Contact
Adams Clinical Trials, LLC (0.4 mi away) Contact
+32 other location
duloxetine
psychosis
depressive disorder
antidepressants
depressive symptoms
depressive episode
sertraline
mental disorder
venlafaxine
citalopram
esketamine
visa

Summary

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.

Details
Condition Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant
Treatment Placebo, Duloxetine (Oral Antidepressant), Escitalopram (Oral antidepressant), Sertraline (Oral Antidepressant), Venlafaxine Extended Release (XR) (Oral Antidepressant), Esketamine 56 mg, Esketamine 84 mg
Clinical Study IdentifierNCT03434041
SponsorJanssen Research & Development, LLC
Last Modified on9 May 2021

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