Study on Seltorexant for Adults and Elderly with Major Depressive Disorder and Insomnia Symptoms

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What is this study about?

This clinical trial is focused on studying the effects of a medication called seltorexant on adults and elderly patients who have Major Depressive Disorder with symptoms of insomnia. Major Depressive Disorder, often referred to as depression, is a condition characterized by persistent feelings of sadness and loss of interest, which can significantly impact daily life. Insomnia is a common symptom of depression, where individuals have trouble falling or staying asleep.

The purpose of the study is to evaluate how well seltorexant works when used alongside other antidepressants, specifically those known as SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors). The study will compare the effects of taking seltorexant with a placebo, which looks like the medication but does not contain the active ingredient. The study aims to see if seltorexant can improve depressive symptoms and help maintain these improvements over time.

Participants in the study will take part in two main parts. In the first part, the effectiveness of seltorexant in improving symptoms of depression will be assessed. In the second part, the focus will be on whether seltorexant can help prevent the return of depressive symptoms after initial improvement. The study will involve taking the medication in the form of a film-coated tablet by mouth. The trial is designed to ensure the safety and effectiveness of seltorexant as an additional treatment for those who have not fully responded to their current antidepressant therapy.

1 initial assessment

An initial assessment is conducted to confirm eligibility. This includes a physical examination, checking vital signs, and performing an ECG (a test that measures the electrical activity of the heart).

Eligibility is based on criteria such as age (18 to 74 years), a diagnosis of major depressive disorder with insomnia symptoms, and an inadequate response to certain antidepressants.

2 part 1: treatment phase

Participants receive either seltorexant 20 mg or a placebo as an additional treatment to their current antidepressant. The medication is taken orally in the form of a film-coated tablet.

The goal is to assess the effectiveness of seltorexant in improving depressive symptoms over a period of 43 days.

3 evaluation of response

The change in depressive symptoms is measured using the MADRS (Montgomery-Åsberg Depression Rating Scale) from the start of the treatment to Day 43.

Participants who show a stable response to the treatment may proceed to the next phase.

4 part 2: maintenance phase

Participants who have a stable response enter a double-blind maintenance phase. This phase aims to evaluate the ability of seltorexant to delay the relapse of depressive symptoms.

The time from randomization to the first relapse is monitored during this phase.

5 completion of trial

The trial is estimated to conclude by December 30, 2026.

Participants’ progress and any changes in symptoms are continuously monitored throughout the trial duration.

Who Can Join the Study?

  • Participants must be between 18 and 74 years old.
  • Participants should be in good health based on a physical exam, vital signs check, and heart test (12-lead ECG) done at the start of the study.
  • Participants must meet the DSM-5 criteria for Major Depressive Disorder (MDD) without any psychotic features. DSM-5 is a guide used by doctors to diagnose mental health conditions.
  • Participants should have tried at least one but not more than two antidepressants during their current depression episode, but these did not work well enough. The antidepressant should have been taken for at least 6 weeks at a stable dose.
  • Participants must be taking and handling well one of the following antidepressants: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine. The dose should be stable and at a therapeutic level for at least 6 weeks.
  • Participants should be experiencing a major depressive episode that is at least moderately severe, as measured by a specific depression scale (SIGH-D) during the screening. There should not be a significant improvement in symptoms from the start to the end of the screening.
  • Participants should have a Body Mass Index (BMI) between 18 and 40 kg/m². BMI is a measure of body fat based on height and weight.
  • Participants who are continuing from Part 1 of the study must have completed the treatment phase of Part 1.
  • Participants must be able to consistently tolerate the study medication.

Who Cannot Join the Study?

  • Participants who have a medical condition other than Major Depressive Disorder with Insomnia Symptoms.
  • Participants who have not had an inadequate response to their current SSRI/SNRI antidepressant therapy. SSRI and SNRI are types of medications used to treat depression.
  • Participants who are not within the specified age range for the study.
  • Participants who are not able to follow the study procedures or take the study medication as required.
  • Participants who are part of a vulnerable population that the study is not designed to include.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Mtz Clinical Research Powered By Pratia Warsaw Poland
Unidade Local De Saude De Loures-Odivelas EPE Loures Portugal
Hospital Universitario Infanta Leonor Madrid Spain
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Hospital Universitario Basurto Bilbao Spain
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Diagnostics-Consultancy Center Mladost M Varna OOD Varna Bulgaria
Centrum Medyczne Intercor Sp. z o.o. Bydgoszcz Poland
ProbarE i Lund AB Lund Sweden
ProbarE i Stockholm AB Stockholm Sweden
Medical Center Saint Naum EOOD Sofia Bulgaria
Crystal Comfort s.r.o. Vranov Nad Toplou Slovakia
Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu Liptovsky Mikulas Liptovsky Mikulas Slovakia
Medical Center Zara-Med EOOD Stara Zagora Bulgaria
Promente Sp. z o.o. Bydgoszcz Poland
Azienda Ospedaliera di Padova Padua Italy
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Clintrial s.r.o. Prague Czechia
Spitalul Clinic Judetean De Urgenta Bihor Oradea Romania
A-Shine s.r.o. Plzen Czechia
Univerzitna nemocnica L. Pasteura Kosice Kosice Slovakia
Hospital Clinic De Barcelona Barcelona Spain
Champalimaud Clinical Centre Lisbon Portugal
IRCCS Ospedale Policlinico San Martino Genoa Italy
CTC Clinical Trial Consultants AB Uppsala Sweden
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti Chieti Italy
Hospital Universitario General De Villalba Madrid Spain
Universita Degli Studi Di Brescia Brescia Italy
Spitalul Clinic De Psihiatrie Si Neurologie Brasov Brasov Romania
Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD Sofia Bulgaria
Forbeli s.r.o. Prague Czechia
Hospital CUF Porto S.A. Porto Portugal
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Azienda Sanitaria Locale Di Salerno Battipaglia Italy
Cbxony Fha Mnzgwa Hgeghq Pdpyu Dpp Izfa Tfkwdl Buqtkl Eupm Burgas Bulgaria
Nxvfcezutcpbqfsu Pcyqjuq smbwuc Prague Czechia
Meekeg sacfgm Brno Czechia
Htwkkj Pgjlq Swtq Barcelona Spain
Shuoeohdmdz Wfbefappgc Zsrsrn Pegfubkcdmt Zbgtxunm Puwjugmwgrakdxe Otfrrh Ztrtcweftt W Wzildmwdq Warsaw Poland
Neevejlotpkh Zldgsr Ocxfta Pldrkbmbozkngzu Mtcoza Leszno Poland
Pbgfpdgppz sdzgzb Rimavska Sobota Slovakia
Mrrwvp sutixd Stare Mesto Slovakia
Cuuklrq Ztpudhz Rjmfbk srvewr Bardejov Slovakia
Iyosfabuvo Pmasdx dz Cxakyadka Mzxqdmbiyhb pinrur Bous Alhwypiljp Ewleijsrz sp Rsvi Craiova Romania
Ptdrvrp sgmxmt Prague Czechia
Onzzoks Bqbzq Kgwmzgbghmv Ckqwewsby Sjto Eqz Gwvspmxtidueq Msvsvynqxg Ttzroya Bydgoszcz Poland
Amsaige Odgjyqvdhsu Uzskdwbfhknwl Saonkh Siena Italy
Fqddytoda Pmwo Lx Imrywevksvhgf Byjxjdfqh Dbl Hqberyhf Uopdqgozjoklt Lw Plr Madrid Spain
Csywdr fxs Mnodmc Hbpahz “uuvxq Ns Srogoyaibyeph Ebdw Sofia Bulgaria
Hmgqagjd Vdmg djwqrsdb Barcelona Spain
Ppkspvbhlfy Ganpgbtdh Srt z obom Grudziadz Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
25.03.2025
Czechia Czechia
Recruiting
25.03.2025
Italy Italy
Recruiting
25.03.2025
Poland Poland
Recruiting
25.03.2025
Portugal Portugal
Recruiting
25.03.2025
Romania Romania
Recruiting
25.03.2025
Slovakia Slovakia
Recruiting
25.03.2025
Spain Spain
Recruiting
25.03.2025
Sweden Sweden
Recruiting
25.03.2025

Trial locations

Investigated drugs:

Seltorexant is a medication being studied for its potential to help people with major depressive disorder who also have trouble sleeping. It is used in combination with other antidepressants, specifically SSRIs or SNRIs, to see if it can improve symptoms of depression in those who haven’t responded well to their current treatment. The study is also looking at whether Seltorexant can help prevent the return of depressive symptoms after initial improvement.

Investigated diseases:

Major Depressive Disorder with Insomnia Symptoms – This condition is characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in activities, accompanied by difficulties in falling or staying asleep. Individuals may experience changes in appetite, energy levels, and concentration. The insomnia symptoms can exacerbate the depressive symptoms, creating a cycle that can be challenging to break. Over time, the lack of restful sleep can lead to increased irritability and difficulty in managing daily tasks. The disorder can vary in intensity and duration, with some individuals experiencing more severe symptoms than others.

Trial ID:
2023-509070-36-00
Protocol code:
42847922MDD3003
Trial Phase:
Therapeutic confirmatory (Phase III)

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