RECRUITING

Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Two-Part Multicenter, Double-Blind, Randomized Placebo-Controlled Study to Evaluate Efficacy and Safety and the Maintenance of Effect of 20-(Milligram) mg Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients With Major Depressive Disorder With Insomnia Symptoms

Quick Facts

Study Start:2024-07-25

Study Completion:2027-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06559306

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 74 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * 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	* 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

Inclusion Criteria

Exclusion Criteria

* 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.
* 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

* 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

Contacts and Locations

Study Contact

CONTACT

844-434-4210

Participate-In-This-Study@its.jnj.com

Principal Investigator

Janssen Research & Development, LLC Clinical Trail

STUDY_DIRECTOR

Janssen Research & Development, LLC

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35294

United States

Chandler Clinical Trials

Chandler, Arizona, 85224

United States

SanRo Clinical Research Group LLC WCG Clinical Network

Bryant, Arkansas, 72022

United States

Preferred Research Partners

Little Rock, Arkansas, 72211

United States

Axiom Research

Colton, California, 92324

United States

Excell Research Inc

Oceanside, California, 92056

United States

Prospective Research Innovations Inc

Rancho Cucamonga, California, 91730

United States

Anderson Clinical Research

Redlands, California, 92374

United States

Syrentis Clinical Research

Santa Ana, California, 92705

United States

California Neuroscience Research

Sherman Oaks, California, 91403

United States

Mountain View Clinical Research

Denver, Colorado, 80209

United States

UConn Health Center

Farmington, Connecticut, 06030

United States

Clinical Research of Brandon

Brandon, Florida, 33511

United States

AGA Clinical Trials

Hialeah, Florida, 33012

United States

Reliable Clinical Research

Hialeah, Florida, 33012

United States

Advanced Research Institute of Miami

Homestead, Florida, 33030

United States

Clinical NeuroScience Solutions Inc

Jacksonville, Florida, 32256

United States

Alcanza Clinical Research

Largo, Florida, 33777

United States

Pharmax Research Clinic Inc

Miami, Florida, 33126

United States

Miami Dade Medical Research Institute

Miami, Florida, 33176

United States

Nuovida Research Center

Miami, Florida, 33186

United States

Aqualane Clinical Research

Naples, Florida, 34105

United States

Bravo Health Care Center

North Bay Village, Florida, 33141

United States

Nova Psychiatry INC

Orlando, Florida, 32803

United States

Florida Center for TMS

Saint Augustine, Florida, 32086

United States

Health Synergy Clinical Research

West Palm Beach, Florida, 33407

United States

Advanced Discovery Research

Atlanta, Georgia, 30318

United States

Peachford Hospital-Atlanta Behavorial Research

Dunwoody, Georgia, 30338

United States

Renew Health Clinical Research

Snellville, Georgia, 30078

United States

Revive Research Institute

Elgin, Illinois, 60123

United States

Baber Research Group

Naperville, Illinois, 60563

United States

Boston Clinical Trials

Boston, Massachusetts, 02131

United States

Adams Clinical LLC

Watertown, Massachusetts, 02472

United States

Mankato Clinic

Mankato, Minnesota, 56001

United States

Oasis Clinical Research LLC

Las Vegas, Nevada, 89121

United States

ActivMed Practices and Research

Portsmouth, New Hampshire, 03801

United States

SPRI Clinical Trials, LLC

Brooklyn, New York, 11235

United States

Lucian Miron Manu MD Psychiatry PC

Woodbury, New York, 11797

United States

Haidar Almhana Nieding

Avon Lake, Ohio, 44012

United States

North Star Medical Research

Middleburg Heights, Ohio, 44130

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Clinical Trials of South Carolina

Charleston, South Carolina, 29406

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

BioBehavioral Research of Austin PC

Austin, Texas, 78759

United States

Houston Clinical Trials LLC

Bellaire, Texas, 77401

United States

North Texas Clinical Trials

Fort Worth, Texas, 76104

United States

DM Clinical Research

Houston, Texas, 77081

United States

R and H Clinical Research

Stafford, Texas, 77477

United States

Grayline Research Center

Wichita Falls, Texas, 76309

United States

Cedar Clinical Research

Draper, Utah, 84020

United States

Core Clinical Research

Everett, Washington, 98201

United States

Collaborators and Investigators

Sponsor: Janssen Research & Development, LLC

Janssen Research & Development, LLC Clinical Trail, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-25

Study Completion Date2027-11-30

Study Record Updates

Study Start Date2024-07-25

Study Completion Date2027-11-30

Terms related to this study

Additional Relevant MeSH Terms

Depressive Disorder, Major