Seltorexant: Seltorexant will be administered orally.
Placebo: Matching Placebo tablets will be administered orally.
Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI): SSRI/SNRI will be administered orally.
Study summary
The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
Eligibility
Sex
ALL
Min age
18 Years
Max age
74 Years
Healthy volunteers
No
Inclusion Criteria:
Participants in part 1 and direct enrollers to part 2:
* Meet DSM-5 MDD, without psychotic features based upon clinical assessment and confirmed by the structured clinical interview for DSM-5 Axis I disorders-clinical trials version (SCID-CT) diagnosed with first depressive episode prior to age 60
* Have had an inadequate response to at least 1 but no more than 2 antidepressants, administered at an adequate dose and duration in the current episode of depression. An inadequate response is defined as less than (\<) 50% reduction but with some improvement (that is, improvement greater than \[\>\] 0%) in depressive symptom severity with residual symptoms other than insomnia present, and overall good tolerability, as assessed by the MGH-ATRQ, and this must include the participant's current antidepressant treatment
* Is receiving and tolerating well any one of the following SSRI or SNRI for depressive symptoms at screening, in any formulation and available in the participating country: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine at a stable dose (at therapeutic dose level) for at least 6 weeks
* Having a major depressive episode of at least moderate severity, as assessed with 17-item Hamilton Depression Rating Scale, implemented through the Structured Interview Guide (SIGH-D) in a blinded manner at screening and must not demonstrate a clinically significant improvement from the beginning to end of screening.
Participants entering after completing part 1:
* Must have completed Part 1 DB treatment phase
* Can consistently tolerate study drug (at the end of Part 1), and there is no additional safety risk for the participant if they proceed to Part 2
* Was able to consistently follow the study procedures in Part 1 as judged by the investigator.
* Must be medically stable based on clinical laboratory tests
Exclusion Criteria:
* Has a recent (last 3 months) history of, or current signs and symptoms of, severe renal insufficiency clinically significant or unstable cardiovascular, respiratory, gastrointestinal, neurologic, hematologic, rheumatologic, immunologic or endocrine disorders and uncontrolled Type 1 or Type 2 diabetes mellitus
* Has a history of narcolepsy and seizures
* Has current signs/symptoms of hypothyroidism or hyperthyroidism
* Participants taking thyroid supplementation for antidepressant purposes
* Has Cushing's disease, Addison's disease, primary amenorrhea, or other evidence of significant medical disorders of the HPA axis
Primary outcome measure(s)
Part 1: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 43 — Baseline, Day 43 The MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.
Part 2: Time from Randomization to the First Relapse in Participants Who Achieve a Stable Response — Time from randomization to the first Relapse during the maintenance phase (up to 2 years and 10 months) Stable response is defined as a greater than equal to (\>=) 50 percent (%) reduction in the MADRS total score for the last 3 consecutive visits of the OL stabilization Phase, as assessed by the site investigator. Time from randomization to the first relapse during the DB maintenance phase in participants who achieve a stable response at the end of OL seltorexant treatment will be reported.
Trial sites (205)
Facility
City
Region
Status
University of Alabama at Birmingham
Birmingham
Alabama
Completed
Chandler Clinical Trials
Chandler
Arizona
Completed
University of Arizona
Tucson
Arizona
Recruiting
SanRo Clinical Research Group LLC WCG Clinical Network
Bryant
Arkansas
Recruiting
Preferred Research Partners
Little Rock
Arkansas
Completed
PAMOJA Clinical Institute LLC
Anaheim
California
Recruiting
Axiom Research
Colton
California
Recruiting
Elite Research Network 6
Encino
California
Completed
Behavioral Research Specialists LLC
Glendale
California
Recruiting
WR PRI Los Alamitos
Los Alamitos
California
Completed
Excell Research Inc
Oceanside
California
Recruiting
Prospective Research Innovations Inc
Rancho Cucamonga
California
Completed
Anderson Clinical Research
Redlands
California
Recruiting
Lumos Clinical Research Center LLC
San Jose
California
Recruiting
Syrentis Clinical Research
Santa Ana
California
Completed
California Neuroscience Research
Sherman Oaks
California
Completed
Mountain View Clinical Research
Denver
Colorado
Recruiting
UConn Health Center
Farmington
Connecticut
Recruiting
Clinical Research of Brandon
Brandon
Florida
Recruiting
AGA Clinical Trials
Hialeah
Florida
Recruiting
Reliable Clinical Research
Hialeah
Florida
Recruiting
Advanced Research Institute of Miami
Homestead
Florida
Recruiting
Clinical NeuroScience Solutions Inc
Jacksonville
Florida
Recruiting
Multi Specialty Research Associates Inc
Lake City
Florida
Completed
Alcanza Clinical Research
Largo
Florida
Completed
Pharmax Research Clinic Inc
Miami
Florida
Recruiting
Miami Dade Medical Research Institute
Miami
Florida
Recruiting
Nuovida Research Center
Miami
Florida
Recruiting
Aqualane Clinical Research
Naples
Florida
Completed
Bravo Health Care Center
North Bay Village
Florida
Completed
Nova Psychiatry INC
Orlando
Florida
Recruiting
Florida Center for TMS
Saint Augustine
Florida
Completed
University of South Florida
Tampa
Florida
Completed
Psych Me Medical Research Inc
Tampa
Florida
Recruiting
Interventional Psychiatry of Tampa Bay
Tampa
Florida
Recruiting
Health Synergy Clinical Research
West Palm Beach
Florida
Recruiting
Conquest Research
Winter Park
Florida
Completed
Advanced Discovery Research
Atlanta
Georgia
Recruiting
Agile Clinical Research Trials, LLC
Atlanta
Georgia
Recruiting
iResearch Atlanta LLC
Decatur
Georgia
Recruiting
+ 165 more sites — see the full list on the official registry below.
More Janssen Research & Development, LLC trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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