Tests seltorexant added to antidepressants for depression with insomnia
Tests seltorexant added to antidepressants in adults with depression and insomnia.
Plain-language title generated from the registry record
Registry title: Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
Key facts
- Where
- Bydgoszcz, Gdansk, Gorlice, Grudziądz, Katowice, Leszno, Poznan, and Warsaw, PolandSee the 11 sites
- Phase
- Phase 3
AI summary: who the study is looking for
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
Read by machine on 9 November 2026.
Could this be for you?
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?
Source: NCT06559306, who can take part
Where in Poland
- Centrum Medyczne INTERCOR Sp. z o.o.Bydgoszcz, PolandNo longer taking part
- Ośrodek Badań Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak, Małgorzata TrzaskaBydgoszcz, PolandNo longer taking part
- PROMENTE Sp. z o.o.Bydgoszcz, PolandNo longer taking part
- Centrum Zdrowia AlceaGdansk, PolandNo longer taking part
- Specjalistyczna Praktyka Lekarska Piotr ZalitaczGorlice, PolandNo longer taking part
- Przychodnie Grudziadz sp. z o.o.Grudziądz, PolandNo longer taking part
- Clinic BBP Bozena PawelczykKatowice, PolandNo longer taking part
- Niepubliczny Zaklad Opieki Psychiatrycznej MENTISLeszno, PolandNo longer taking part
- Praktyka Lekarska dr n med Malgorzata Wojtanowska BogackaPoznan, PolandNo longer taking part
- MTZ Clinical Research powered by PratiaWarsaw, PolandNo longer taking part
- Samodzielny Wojewodzki Zespol Publicznych Zakladow Psychiatrycznej Opieki Zdrowotnej W WarszawieWarsaw, PolandNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT06559306EU 2023-509070-36-00
- Record updated
- 3 November 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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: 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.