Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Aug 15, 2024
Trial Information
Current as of July 23, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called seltorexant to see how well it helps adults and elderly people who have major depressive disorder (MDD) along with insomnia symptoms. The goal is to find out if seltorexant can improve mood and sleep when used alongside a currently prescribed antidepressant that hasn't been fully effective. Participants must be between 18 and 75 years old and should have already tried at least one or two antidepressants without getting enough relief from their depression, meaning they still have some ongoing symptoms.
If you or a loved one qualifies, you can expect to take part in this study, which will involve taking either seltorexant or a placebo (a look-alike pill that doesn’t contain the active medication) for a certain period while continuing the current antidepressant treatment. The study will monitor how well the medication works and if there are any safety concerns. It’s important to note that not everyone will be eligible; for example, those with certain serious medical conditions or those who have had specific health issues like seizures or thyroid problems may not qualify. Overall, this trial aims to find better treatment options for those struggling with depression and sleep issues.
Gender
ALL
Eligibility criteria
- 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
About Janssen Research & Development, Llc
Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson, is a leading pharmaceutical company dedicated to advancing innovative therapies in multiple therapeutic areas, including oncology, immunology, neuroscience, infectious diseases, and cardiovascular health. With a strong commitment to scientific excellence and patient-centered research, Janssen leverages cutting-edge technology and collaborative partnerships to drive the development of transformative treatments. The company is focused on addressing unmet medical needs through rigorous clinical trials and a robust pipeline, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Houston, Texas, United States
Philadelphia, Pennsylvania, United States
Birmingham, Alabama, United States
Charleston, South Carolina, United States
Madrid, , Spain
Columbus, Ohio, United States
Tucson, Arizona, United States
Chicago, Illinois, United States
Redlands, California, United States
Tampa, Florida, United States
Farmington, Connecticut, United States
Denver, Colorado, United States
Mankato, Minnesota, United States
Homestead, Florida, United States
Charleston, South Carolina, United States
Genova, , Italy
Roma, , Italy
Bilbao, , Spain
Austin, Texas, United States
Hialeah, Florida, United States
Pisa, , Italy
Brooklyn, New York, United States
Boston, Massachusetts, United States
North Bay Village, Florida, United States
Middleburg Heights, Ohio, United States
Naperville, Illinois, United States
Lund, , Sweden
Mount Kisco, New York, United States
Little Rock, Arkansas, United States
Brooklyn, New York, United States
Brandon, Florida, United States
Madrid, , Spain
Miami, Florida, United States
Sherman Oaks, California, United States
Cincinnati, Ohio, United States
Santa Ana, California, United States
Cordoba, , Argentina
Belgrade, , Serbia
Cordoba, , Argentina
Nuevo Leon, , Mexico
Decatur, Georgia, United States
Madrid, , Spain
Jacksonville, Florida, United States
Wichita Falls, Texas, United States
Dallas, Texas, United States
Leszno, , Poland
Everett, Washington, United States
Hialeah, Florida, United States
Fort Worth, Texas, United States
Winter Park, Florida, United States
Atlanta, Georgia, United States
Varna, , Bulgaria
Trabzon, , Turkey
Kovin, , Serbia
Savannah, Georgia, United States
Oceanside, California, United States
Catania, , Italy
Portsmouth, New Hampshire, United States
Ankara, , Turkey
Sofia, , Bulgaria
Draper, Utah, United States
Colton, California, United States
Ankara, , Turkey
Edmond, Oklahoma, United States
Bellaire, Texas, United States
La Plata, , Argentina
Rancho Cucamonga, California, United States
Stockholm, , Sweden
Samsun, , Turkey
Elgin, Illinois, United States
Santiago Del Estero, , Argentina
Belgrade, , Serbia
Miami, Florida, United States
Sofia, , Bulgaria
Barcelona, , Spain
Kocaeli, , Turkey
Snellville, Georgia, United States
Miami, Florida, United States
Bydgoszcz, , Poland
Avon Lake, Ohio, United States
Naples, Florida, United States
Monterrey, , Mexico
Warszawa, , Poland
Atlanta, Georgia, United States
Houston, Texas, United States
Stafford, Texas, United States
Brasov, , Romania
Warszawa, , Poland
Oradea, , Romania
Gorlice, , Poland
Chandler, Arizona, United States
Ankara, , Turkey
Tampa, Florida, United States
Ciudad Autonoma De Buenos Aires, , Argentina
Vranov Nad Toplou, , Slovakia
Kosice, , Slovakia
Rio De Janeiro, , Brazil
Rosario, , Argentina
Stara Zagora, , Bulgaria
Porto Alegre, , Brazil
Orlando, Florida, United States
Sao Paulo, , Brazil
Glendale, California, United States
Siena, , Italy
Bursa, , Turkey
Austin, Texas, United States
Praha 10, , Czechia
Cincinnati, Ohio, United States
Brasilia, , Brazil
Cordoba, , Argentina
Cordoba, , Argentina
Sao Bernardo Do Campo, , Brazil
Lisboa, , Portugal
Barcelona, , Spain
Bydgoszcz, , Poland
Barcelona, , Spain
West Palm Beach, Florida, United States
Praha 6, , Czechia
San Jose, California, United States
New York, New York, United States
Loures, , Portugal
Lake City, Florida, United States
Plzen, , Czechia
Porto Alegre, , Brazil
Collado Villalba, , Spain
Bryant, Arkansas, United States
Largo, Florida, United States
Dunwoody, Georgia, United States
Watertown, Massachusetts, United States
Las Vegas, Nevada, United States
Woodbury, New York, United States
Gdansk, , Poland
Saint Augustine, Florida, United States
Criciuma, , Brazil
Mexico City, , Mexico
Porto, , Portugal
Encino, California, United States
Tampa, Florida, United States
Peachtree Corners, Georgia, United States
Buffalo, New York, United States
Campinas, , Brazil
Grudziadz, , Poland
Poznan, , Poland
Bucuresti, , Romania
Braga, , Portugal
Lisboa, , Portugal
Focsani, , Romania
New York, New York, United States
Natal, , Brazil
Praha 2, , Czechia
Las Vegas, Nevada, United States
Molndal, , Sweden
Craiova, , Romania
Sibiu, , Romania
Los Alamitos, California, United States
Anaheim, California, United States
Garland, Texas, United States
Plovdiv, , Bulgaria
Mexico City, , Mexico
Mexico City, , Mexico
Nuevo Leon, , Mexico
Katowice, , Poland
Ponta Delgada, , Portugal
Liptovsky Mikulas, , Slovakia
Rimavska Sobota, , Slovakia
Svidnik, , Slovakia
Uppsala, , Sweden
Bursa, , Turkey
Gaziantep, , Turkey
Istanbul, , Turkey
Passo Fundo, , Brazil
Porto Alegre, , Brazil
Sao Paulo, , Brazil
Brescia, , Italy
Touguinho, , Portugal
Novi Knezevac, , Serbia
Bratislava, , Slovakia
Homestead, Florida, United States
Chicago, Illinois, United States
Hickory, North Carolina, United States
Chieti, , Italy
Cluj Napoca, , Romania
Iasi, , Romania
Salerno, , Italy
San Luis De Potosi, , Mexico
Lisbon, , Portugal
Patients applied
Trial Officials
Janssen Research & Development, LLC Clinical Trail
Study Director
Janssen Research & Development, LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported