Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
Recruiting · NCT06559306 · Interventional (participants receive a specific treatment) · Lead sponsor: Janssen Research & Development, LLC
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboSelective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)Seltorexant
What this trial is about
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).
Who can take part
Age range
18 Years to 74 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 22 US states.
- University of Alabama at Birmingham - Birmingham, Alabama, United States
- Chandler Clinical Trials - Chandler, Arizona, United States
- University of Arizona - Tucson, Arizona, United States
- SanRo Clinical Research Group LLC WCG Clinical Network - Bryant, Arkansas, United States
- Preferred Research Partners - Little Rock, Arkansas, United States
- PAMOJA Clinical Institute LLC - Anaheim, California, United States
- Axiom Research - Colton, California, United States
- Elite Research Network 6 - Encino, California, United States
- Behavioral Research Specialists LLC - Glendale, California, United States
- WR PRI Los Alamitos - Los Alamitos, California, United States
- Excell Research Inc - Oceanside, California, United States
- Prospective Research Innovations Inc - Rancho Cucamonga, California, United States
- Anderson Clinical Research - Redlands, California, United States
- Lumos Clinical Research Center LLC - San Jose, California, United States
- Syrentis Clinical Research - Santa Ana, California, United States
- California Neuroscience Research - Sherman Oaks, California, United States
- Mountain View Clinical Research - Denver, Colorado, United States
- UConn Health Center - Farmington, Connecticut, United States
- Clinical Research of Brandon - Brandon, Florida, United States
- AGA Clinical Trials - Hialeah, Florida, United States
- Reliable Clinical Research - Hialeah, Florida, United States
- Advanced Research Institute of Miami - Homestead, Florida, United States
- Clinical NeuroScience Solutions Inc - Jacksonville, Florida, United States
- Multi Specialty Research Associates Inc - Lake City, Florida, United States
- Alcanza Clinical Research - Largo, Florida, United States
- Pharmax Research Clinic Inc - Miami, Florida, United States
- Miami Dade Medical Research Institute - Miami, Florida, United States
- Nuovida Research Center - Miami, Florida, United States
- Aqualane Clinical Research - Naples, Florida, United States
- Bravo Health Care Center - North Bay Village, Florida, United States
- Nova Psychiatry INC - Orlando, Florida, United States
- Florida Center for TMS - Saint Augustine, Florida, United States
- University of South Florida - Tampa, Florida, United States
- Psych Me Medical Research Inc - Tampa, Florida, United States
- Interventional Psychiatry of Tampa Bay - Tampa, Florida, United States
- Health Synergy Clinical Research - West Palm Beach, Florida, United States
- Conquest Research - Winter Park, Florida, United States
- Advanced Discovery Research - Atlanta, Georgia, United States
- Agile Clinical Research Trials, LLC - Atlanta, Georgia, United States
- iResearch Atlanta LLC - Decatur, Georgia, United States
- Peachford Hospital-Atlanta Behavorial Research - Dunwoody, Georgia, United States
- iResearch Savannah - Savannah, Georgia, United States
- Accelerated Clinical Research Group LLC - Snellville, Georgia, United States
- Renew Health Clinical Research - Snellville, Georgia, United States
- Northwestern University - Chicago, Illinois, United States
- MetroMed Clinical Research - Chicago, Illinois, United States
- University of Chicago Medical Center - Chicago, Illinois, United States
- Revive Research Institute - Elgin, Illinois, United States
- Baber Research Group - Naperville, Illinois, United States
- Boston Clinical Trials - Boston, Massachusetts, United States
- Adams Clinical LLC - Watertown, Massachusetts, United States
- Mankato Clinic - Mankato, Minnesota, United States
- Redbird Research - Las Vegas, Nevada, United States
- Oasis Clinical Research LLC - Las Vegas, Nevada, United States
- ActivMed Practices and Research - Portsmouth, New Hampshire, United States
- Integrative Clinical Trials LLC - Brooklyn, New York, United States
- SPRI Clinical Trials, LLC - Brooklyn, New York, United States
- University at Buffalo Psychiatry - Buffalo, New York, United States
- Bioscience Research LLC - Mount Kisco, New York, United States
- Fieve Clinical Research Inc - New York, New York, United States
Showing 60 of 205 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →