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RecruitingPhase 3

Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms

A Two-Part Multicenter, Double-Blind, Randomized Placebo-Controlled Study to Evaluate Efficacy and Safety and the Maintenance of Effect of 20-(Milligram) mg Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients With Major Depressive Disorder With Insomnia Symptoms

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 74 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests seltorexant added to an antidepressant for adults, including older adults, with major depression and trouble sleeping. It compares seltorexant with a placebo (a pill with no active medicine) to see how well it works, how safe it is, and whether its effects last. It is for people whose current SSRI or SNRI antidepressant has not helped enough.

The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • For Part 1 or direct entry to Part 2: Have major depression without psychosis (such as seeing or hearing things that are not there). Your first depression episode must have started before age 60.
  • During your current depression episode, have tried 1 or 2 antidepressants at a proper dose for enough time. They must have helped some, but reduced symptoms by less than half, with symptoms besides sleep trouble still present.
  • Be taking one of the study's allowed SSRI or SNRI antidepressants, which are types of depression medicine. You must tolerate it well and have taken the same treatment dose for at least 6 weeks.
  • Have at least moderate depression on the study's rating test, with no major improvement during screening.
  • To enter Part 2 after Part 1: Have completed Part 1's blinded treatment phase, when treatment assignments are kept hidden.
  • At the end of Part 1, be able to tolerate the study medicine and continue without added safety risk.
  • Have followed study steps reliably in Part 1, as judged by the study doctor.
  • Be medically stable based on lab tests before continuing from Part 1.

Who can't join

  • Have severe kidney problems, serious or unstable disease in major body systems, or uncontrolled type 1 or type 2 diabetes now or within the past 3 months.
  • Have a history of narcolepsy (a disorder that causes sudden sleep) and seizures.
  • Have current signs or symptoms of an underactive or overactive thyroid, a gland that helps control how your body uses energy.
  • Take thyroid medicine to treat depression.
  • Have Cushing's disease or Addison's disease (hormone disorders), primary amenorrhea (menstrual periods have never started), or another serious disorder of the body's stress-hormone system.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (84)

AL

AR

AZ

CA

CO

CT

FL

GA

IL

MA

MN

NC

NH

NV

NY

OH

OK

PA

SC

TX

UT

WA