Recruiting
Phase 3

Seltorexant with Insomnia

Sponsor:

Janssen Research & Development, LLC

Code:

NCT06559306

Conditions

Depressive Disorder, Major

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Seltorexant

Placebo

Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)

Study Details

Brief 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).

Conditions

Depressive Disorder, Major

Study ID

NCT06559306

Start date

Jul 25, 2024

Status verified date

Aug, 2026

Completion date

Apr 15, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

752 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: Seltorexant

Participants will receive seltorexant orally once daily for 6 weeks during the double-blind (DB) treatment phase in Part 1 of the study. Participants who do not proceed to Part 2 of the study will undergo a post-treatment follow-up phase, after the DB treatment phase in Part 1 and will continue to take their single baseline selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant throughout the study.

placebo comparator: Part 1: Placebo

Participants will receive matching placebo orally once daily for 6 weeks during the DB treatment phase in Part 1 of the study. Participants who do not proceed to Part 2 of the study will undergo a post-treatment follow-up phase, after the DB treatment phase in Part 1 and will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.

experimental: Part 2: Open Label (OL) Seltorexant

All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. In Part 2 open-label phases (induction and stabilization) all participants (newly enrolled direct entry participants and Part 1 roll-over participants) will receive seltorexant orally in addition to their background SSRI/SNRI treatment.

experimental: Part 2: DB Seltorexant

All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. Participants who achieve a stable response during the open-label phase will receive treatment with seltorexant orally once daily during DB Maintenance Phase in Part 2 of the study. Participants will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.

placebo comparator: Part 2: DB Placebo

All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. Participants who achieve a stable response during the open-label phases will receive treatment with matching placebo orally once daily during DB Maintenance Phase in Part 2 of the study. Participants will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.

Interventions

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.

Primary outcome measure

  • Part 1: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 43 [ Time Frame: Baseline, Day 43 ]
  • Part 2: Time from Randomization to the First Relapse in Participants Who Achieve a Stable Response [ Time Frame: Time from randomization to the first Relapse during the maintenance phase (up to 2 years and 10 months) ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85724

SanRo Clinical Research Group LLC WCG Clinical Network

Recruiting

Bryant, Arkansas, United States, 72022

PAMOJA Clinical Institute LLC

Recruiting

Anaheim, California, United States, 92801

Axiom Research

Recruiting

Colton, California, United States, 92324

Behavioral Research Specialists LLC

Recruiting

Glendale, California, United States, 91206

Excell Research Inc

Recruiting

Oceanside, California, United States, 92056

Anderson Clinical Research

Recruiting

Redlands, California, United States, 92374

Lumos Clinical Research Center LLC

Recruiting

San Jose, California, United States, 95124

Mountain View Clinical Research

Recruiting

Denver, Colorado, United States, 80209

UConn Health Center

Recruiting

Farmington, Connecticut, United States, 06030

Clinical Research of Brandon

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Brandon, Florida, United States, 33511

AGA Clinical Trials

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Hialeah, Florida, United States, 33012

Reliable Clinical Research

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Hialeah, Florida, United States, 33012

Advanced Research Institute of Miami

Recruiting

Homestead, Florida, United States, 33033

Clinical NeuroScience Solutions Inc

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Jacksonville, Florida, United States, 32256

Pharmax Research Clinic Inc

Recruiting

Miami, Florida, United States, 33126

Miami Dade Medical Research Institute

Recruiting

Miami, Florida, United States, 33176

Nuovida Research Center

Recruiting

Miami, Florida, United States, 33186

Nova Psychiatry INC

Recruiting

Orlando, Florida, United States, 32803

Psych Me Medical Research Inc

Recruiting

Tampa, Florida, United States, 33614

Interventional Psychiatry of Tampa Bay

Recruiting

Tampa, Florida, United States, 33629

Health Synergy Clinical Research

Recruiting

West Palm Beach, Florida, United States, 33407

Advanced Discovery Research

Recruiting

Atlanta, Georgia, United States, 30318

Agile Clinical Research Trials, LLC

Recruiting

Atlanta, Georgia, United States, 30328

iResearch Atlanta LLC

Recruiting

Decatur, Georgia, United States, 30030

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Baber Research Group

Recruiting

Naperville, Illinois, United States, 60563

Adams Clinical LLC

Recruiting

Watertown, Massachusetts, United States, 02472

Integrative Clinical Trials LLC

Recruiting

Brooklyn, New York, United States, 11229

SPRI Clinical Trials, LLC

Recruiting

Brooklyn, New York, United States, 11235

Bioscience Research LLC

Recruiting

Mount Kisco, New York, United States, 10549

Fieve Clinical Research Inc

Recruiting

New York, New York, United States, 10017

Patient Priority Clinical Sites LLC

Recruiting

Cincinnati, Ohio, United States, 45215

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Conrad Clinical Research

Recruiting

Edmond, Oklahoma, United States, 73013

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Clinical Trials of South Carolina

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Charleston, South Carolina, United States, 29406

Houston Clinical Trials LLC

Recruiting

Bellaire, Texas, United States, 77401

North Texas Clinical Trials

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Fort Worth, Texas, United States, 76104

Baylor College of Medicine

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Houston, Texas, United States, 77030

DM Clinical Research

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Houston, Texas, United States, 77081

R and H Clinical Research

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Stafford, Texas, United States, 77477

Grayline Research Center

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Wichita Falls, Texas, United States, 76309

Core Clinical Research

Recruiting

Everett, Washington, United States, 98201

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.