Last updated 9 days ago
Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
752 patients around the world
Available in Argentina
Janssen Research & Development, LLC
1Research sites
752Patients around the world
This study is for people with
Depression
Major depression
Requirements for the patient
To 74 Years
All Gender
Medical requirements
- Participants in part 1 and direct enrollers to part 2: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.Participants in part 1 and direct enrollers to part 2 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.Participants in part 1 and direct enrollers to part 2 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.Participants in part 1 and direct enrollers to part 2 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 1must have completed Part 1 DB treatment phase.Participants entering after completing part 1 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.Participants entering after completing part 1 was able to consistently follow the study procedures in Part 1 as judged by the investigator.Participants entering after completing part 1 must be medically stable based on clinical laboratory tests.
- 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.
Sites
Sanatorio Privado Prof. Leon S Morra S.A.
Recruiting
SponsorJanssen Research & Development, LLC
Study typeInterventional
Conditions
Major depression
Requirements
To 74 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06559306
