Phase
Condition
Depression
Treatment
Seltorexant
Placebo
Clinical Study ID
Ages 12-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has inadequate response to trial of at least 1, but no more than 2 antidepressanttreatments during the current major depressive episode including their currentantidepressant fluoxetine or escitalopram (SSRI). Inadequate response is determinedas less than (<) 50 percentage (%) symptom reduction after adequate antidepressanttreatment for at least 6 weeks at or above the minimum therapeutic dose prior toscreening
Has had access to adequate psychotherapy in the current depressive episode (based oninvestigator judgement/local guidance) prior to randomization
Must have Children's Depression Rating Scale-Revised (CDRS-R) total score greaterthan 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 participantsbelow fifth percentile may participate following medical clearance, as long as theirbaseline weight is >=30 kilograms (kg)
A female participant of childbearing potential must have a negative urine pregnancytest at screening and baseline
Exclusion
Exclusion Criteria:
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 metabolicdisturbances. 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 spectrumdisorder, borderline personality disorder, somatoform disorders, or fibromyalgia. Aprior history of one or more of these disorders is allowed as long as thedisorder(s) are currently stable and major depressive disorder (MDD) is notsecondary to the original diagnosis. Has a current or prior DSM-5 diagnosis of apsychotic disorder, or bipolar disorder
Has a significant primary sleep disorder (example, obstructive sleep apnea,parasomnias) at screening but participants with insomnia or hypersomnia disordersare allowed
At significant risk of committing suicide based on history or according to theinvestigator'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 3months or a history of suicidal behavior within the last 6 months
Has known allergies, hypersensitivity, or intolerance to seltorexant or itsexcipients
Study Design
Study Description
Connect with a study center
G.Gaslini Institute
Genova, 16147
ItalySite Not Available
Ospedale Pediatrico Bambin Gesù
Roma, 00165
ItalySite Not Available
Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario 'A. Gemelli'
Roma, 00168
ItalySite Not Available
Hosp. Sant Joan de Deu
Esplugues de Llobregat, 08950
SpainSite Not Available
Clinica Univ. de Navarra Madrid
Madrid, 28027
SpainSite Not Available
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28007
SpainSite Not Available
Hosp. Gral. Univ. Gregorio Marañon
Madrid, 28007
SpainActive - Recruiting
Hosp. Univ. Ramon Y Cajal
Madrid, 28034
SpainSite Not Available
Hosp. Univ. Pta. de Hierro Majadahonda
Majadahonda, 28222
SpainSite Not Available
Corporacio Sanitari Parc Tauli
Sabadell, 08208
SpainSite Not Available
Skane University Hospital
Lund, 22185
SwedenSite Not Available
Uppsala University
Uppsala, 75321
SwedenSite Not Available
NHS Greater Glasgow and Clyde
Glasgow, G12 0XH
United KingdomSite Not Available
South London and Maudsley NHS Foundation Trust of The Maudsley Hospital
London, SE5 8AZ
United KingdomSite Not Available
Greater Manchester Mental Health NHSFT
Manchester, M25 3BL
United KingdomSite Not Available
Warneford Hospital, NIHR Clinical Research Facility
Oxford, OX7 3JX
United KingdomSite Not Available
Southwest Autism Research and Resource Center
Phoenix, Arizona 85006
United StatesSite Not Available
Advanced Research Center Inc
Anaheim, California 92805
United StatesSite Not Available
University of California at San Diego
San Diego, California 92103-8620
United StatesSite Not Available
Yale University
New Haven, Connecticut 06520
United StatesSite Not Available
Children's National Medical Center
Washington, District of Columbia 20010
United StatesSite Not Available
Sarkis Clinical Trials
Gainesville, Florida 32607
United StatesSite Not Available
Segal Trials
Lauderhill, Florida 33319
United StatesSite Not Available
APG Research LLC
Orlando, Florida 32803
United StatesSite Not Available
APG Research, LLC
Orlando, Florida 32803
United StatesActive - Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United StatesSite Not Available
Baber Research Group
Naperville, Illinois 60563
United StatesSite Not Available
Beacon Medical Group Clinical Research
South Bend, Indiana 46601
United StatesSite Not Available
Manhattan Behavioral Medicine
New York, New York 10036
United StatesSite Not Available
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
United StatesSite Not Available
CincyScience
West Chester, Ohio 45069
United StatesSite Not Available
Vanderbilt University
Nashville, Tennessee 37212
United StatesSite Not Available
University of Texas Southwestern Medical Center
Dallas, Texas 75247
United StatesSite Not Available
Family Psychiatry of The Woodlands
The Woodlands, Texas 77381
United StatesSite Not Available
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