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Taking peoplePhase 3

Tests seltorexant added to antidepressants for depression with insomnia

Tests seltorexant added to antidepressants in adults with depression and insomnia.

Key facts

Who runs it
Janssen Research & Development, LLC
Where
Burgas, Plovdiv, Sofia, Sofiya, Stara Zagora, and Varna, BulgariaSee the 7 sitesAlso in 15 other countries, 190 sites
Registry title
Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
Status
Recruiting
Phase
Phase 3
People taking part
752 people, planned
Started
25 Jul 2024
Expected to end
4 May 2029
Type of study
Interventional, 5 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Seltorexant
  • Placebo
  • Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
Record updated
3 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with major depressive disorder and insomnia symptoms. Their depression has not improved enough on an SSRI or SNRI antidepressant.

Age
18 to 74 years
Sex
All sexes can join.
Disease stage
Major depressive episode of at least moderate severity, first depressive episode before age 60, without psychotic features. Insomnia symptoms are part of the condition.
Earlier treatment
Inadequate response to at least 1 but no more than 2 antidepressants in the current episode. Must be taking one of the listed SSRIs or SNRIs at a stable dose for at least 6 weeks and tolerating it well.

Main reasons for not taking part

  • Severe kidney problems, or unstable heart, lung, stomach/bowel, nerve, blood, rheumatic, immune or hormone disorders in the last 3 months
  • Uncontrolled type 1 or type 2 diabetes
  • History of narcolepsy or seizures
  • Signs or symptoms of an underactive or overactive thyroid, or taking thyroid supplements for antidepressant purposes
  • Cushing's disease, Addison's disease, primary amenorrhea or other significant disorders of the HPA axis

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 Cushing's disease, Addison's disease, primary amenorrhea, or other evidence of significant medical disorders of the HPA axis
  • Has current signs/symptoms of hypothyroidism or hyperthyroidism
  • Participants taking thyroid supplementation for antidepressant purposes

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 74 years old?

Where in Bulgaria

Also in 15 other countries, 190 sites

  • Center For Mental Health Prof. Dr. Ivan Temkov Burgas EOODBurgas, BulgariaNo longer taking part
  • University Multiprofile Hospital For Active Treatment Saint Georgi EADPlovdiv, BulgariaNo longer taking part
  • Center For Mental Health Prof. N. Shipkovenski EOODSofia, BulgariaNo longer taking part
  • Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OODSofiya, BulgariaNo longer taking part
  • Medical Center Saint Naum EOODSofiya, BulgariaNo longer taking part
  • Medical Center Zara-Med EOODStara Zagora, BulgariaNo longer taking part
  • Diagnostics-Consultancy Center Mladost M Varna OODVarna, BulgariaNo longer taking part

About the trial

What the trial wants to find out

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).

The 5 groups in the trial

  • Part 1: SeltorexantTreatment being tested

    Participants will receive seltorexant orally once daily for 6 weeks during the double-blind (DB) treatment phase in Part 1 of the study. Participants who do not proceed to Part 2 of the study will undergo a post-treatment follow-up phase, after the DB treatment phase in Part 1 and will continue to take their single baseline selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant throughout the study.

    Treatment: Seltorexant and Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)

  • Part 1: PlaceboPlacebo, for comparison

    Participants will receive matching placebo orally once daily for 6 weeks during the DB treatment phase in Part 1 of the study. Participants who do not proceed to Part 2 of the study will undergo a post-treatment follow-up phase, after the DB treatment phase in Part 1 and will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.

    Treatment: Placebo and Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)

  • Part 2: Open Label (OL) SeltorexantTreatment being tested

    All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. In Part 2 open-label phases (induction and stabilization) all participants (newly enrolled direct entry participants and Part 1 roll-over participants) will receive seltorexant orally in addition to their background SSRI/SNRI treatment.

    Treatment: Seltorexant and Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)

  • Part 2: DB SeltorexantTreatment being tested

    All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. Participants who achieve a stable response during the open-label phase will receive treatment with seltorexant orally once daily during DB Maintenance Phase in Part 2 of the study. Participants will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.

    Treatment: Seltorexant and Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)

  • Part 2: DB PlaceboPlacebo, for comparison

    All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. Participants who achieve a stable response during the open-label phases will receive treatment with matching placebo orally once daily during DB Maintenance Phase in Part 2 of the study. Participants will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.

    Treatment: Placebo and Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests seltorexant added to antidepressants for depression with insomniaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06559306, who can take part
Record updated
3 November 2026