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Search / Trial NCT06559306

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.

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

KR

2 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