A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adolescents With Major Depressive Disorder Who Have an Inadequate Response to Selective Serotonin Reuptake Inhibitor (SSRI) and Psychotherapy

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Depressive Disorder, Major

In brief

The purpose of this study is to assess the safety and tolerability of Seltorexant as adjunctive therapy to an antidepressant in adolescents with major depressive disorder (MDD) in the short-term compared with placebo.

Key facts

Study ID

NCT04951609

Run by

Janssen Research & Development, LLC

People needed

31

Starts

2021-09-02

Expected to finish

2024-04-08

Last updated by the study team

2025-04-27

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has inadequate response to trial of at least 1, but no more than 2 antidepressant treatments during the current major depressive episode including their current antidepressant fluoxetine or escitalopram (SSRI). Inadequate response is determined as less than (<) 50 percentage (%) symptom reduction after adequate antidepressant treatment for at least 6 weeks at or above the minimum therapeutic dose prior to screening
• Has had access to adequate psychotherapy in the current depressive episode (based on investigator judgement/local guidance) prior to randomization
• Must have Children's Depression Rating Scale-Revised (CDRS-R) total score greater than or equal to (>=) 48 at screening and >=40 at the baseline visit
• Participants weighing between fifth and ninety-fifth percentile for age and sex. Obese participants greater than ninety-fifth percentile and underweight participants below fifth percentile may participate following medical clearance, as long as their baseline weight is >=30 kilograms (kg)
• A female participant of childbearing potential must have a negative urine pregnancy test at screening and baseline

You may not qualify if…

• Has a history of liver or renal insufficiency, significant cardiac (example, congenital heart disease, cardiomyopathy, or tachyarrhythmias), vascular, pulmonary, gastrointestinal, endocrine (including uncontrolled hyperthyroidism), neurologic (including seizure disorder), hematologic, rheumatologic, psychiatric, or metabolic disturbances. Stable medical conditions are allowed
• Has current the diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) diagnosis of conduct disorder, intellectual disability, autism spectrum disorder, borderline personality disorder, somatoform disorders, or fibromyalgia. A prior history of one or more of these disorders is allowed as long as the disorder(s) are currently stable and major depressive disorder (MDD) is not secondary to the original diagnosis. Has a current or prior DSM-5 diagnosis of a psychotic disorder, or bipolar disorder
• Has a significant primary sleep disorder (example, obstructive sleep apnea, parasomnias) at screening but participants with insomnia or hypersomnia disorders are allowed
• At significant risk of committing suicide based on history or according to the investigator's experience, or based on active suicidal ideation, intent or plan, item 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past 3 months or a history of suicidal behavior within the last 6 months
• Has known allergies, hypersensitivity, or intolerance to seltorexant or its excipients

Where it is running

• Southwest Autism Research and Resource Center — Phoenix, Arizona, United States
• Advanced Research Center Inc — Anaheim, California, United States
• University of California at San Diego — San Diego, California, United States
• Yale University — New Haven, Connecticut, United States
• Sarkis Clinical Trials — Gainesville, Florida, United States
• APG Research LLC — Orlando, Florida, United States
• Baber Research Group — Naperville, Illinois, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• CincyScience — West Chester, Ohio, United States
• Vanderbilt University — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Family Psychiatry of The Woodlands — The Woodlands, Texas, United States
• G.Gaslini Institute — Genova, Italy
• Ospedale Pediatrico Bambin Gesù — Roma, Italy
• Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario 'A. Gemelli' — Roma, Italy
• Hosp. Sant Joan de Deu — Esplugues de Llobregat, Spain
• Hosp. Gral. Univ. Gregorio Maranon — Madrid, Spain
• Clinica Univ. de Navarra Madrid — Madrid, Spain
• Hosp. Univ. Ramon Y Cajal — Madrid, Spain
• Hosp. Univ. Pta. de Hierro Majadahonda — Majadahonda, Spain
• Corporacio Sanitari Parc Tauli — Sabadell, Spain
• South London and Maudsley NHS Foundation Trust of The Maudsley Hospital — London, United Kingdom
• Warneford Hospital, NIHR Clinical Research Facility — Oxford, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.