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Depressive Disorder, MajorPhase 3NCT04532749

A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy

A Phase 3 study testing Seltorexant in people with Depressive Disorder, Major, run by Janssen Research & Development, LLC at 80 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to assess the efficacy of Seltorexant compared with placebo as 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… Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Depressive Disorder, Major
What is being tested?
Seltorexant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
212 participants
Where
80 sitesin 10 countries
Study dates
15 Sep 2020to 14 Jul 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Meet diagnostic and statistical manual of mental disorders-5th edition (DSM-5) diagnostic criteria for major depressive disorder (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. The duration of the current depressive episode must be less than or equal to (<=) 24 months
  • 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. The current antidepressant cannot be the first antidepressant treatment for the first lifetime episode of depression. An inadequate response is defined as less than (<) 50 percent (%) 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
  • Is receiving and tolerating well any one of the following selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (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, and for no greater than 18 months in the current episode
  • Have a hamilton depression rating scale (HDRS)-17 total score greater than or equal to (>=) 20 at the first screening interview, must not demonstrate a clinically significant improvement (that is [ie], an improvement of > 20 % on their HDRS-17 total score) from the first to the second independent HDRS-17 rating, and must have a HDRS-17 total score >= 18 at the second screening interview
  • Have a patient version of the Insomnia Severity Index (ISI) total score >=15 as well as a clinician version of the ISI total score >=15 at the second screening visit
  • Body mass index (BMI) between 18 and 40 kilogram per meter square (kg/m^2) inclusive (BMI=weight/height^2)
  • Participant must be medically stable on the basis of clinical laboratory tests performed at screening
  • Participant must be medically stable on the basis of the following: physical examination (including a brief neurological examination), vital signs (including blood pressure), and 12-lead electrocardiogram (ECG) performed at screening and baseline

Who cannot join

  • Has a recent (last 3 months) history of, or current signs and symptoms of, severe renal insufficiency (creatinine clearance [CrCl] < 30 milliliter per minute [mL/min]); clinically significant or unstable cardiovascular, respiratory, gastrointestinal, neurologic, hematologic, rheumatologic, immunologic or endocrine disorders and uncontrolled Type 1 or Type 2 diabetes mellitus
  • Has clinically significant hepatic disease as defined by >=2*Upper Limit of Normal (ULN) increase of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) at screening
  • Has a history of treatment-resistant MDD, defined as a lack of response to 2 or more adequate antidepressant treatments in the current episode, as indicated by no or minimal (< 25% improvement in symptoms) when treated with an antidepressant of adequate dose (per massachusetts general hospital-antidepressant treatment response questionnaire [MGH-ATRQ]) and duration (at least 6 weeks).
  • Has history or current diagnosis of a psychotic disorder, bipolar disorder, intellectual disability, autism spectrum disorder, borderline personality disorder, or somatoform disorders
  • Has any significant primary sleep disorder, including but not limited to obstructive sleep apnea, restless leg syndrome, or parasomnias. Participants with insomnia disorder are allowed
  • Has a history of moderate to severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening

Trial locations and contacts

80 sites in 10 countries.

80 sites in 10 countries

United States26 sites

  • Michigan Clinical Research Institute

    Ann Arbor, Michigan, 48108

  • Synexus Clinical Research US Inc

    Atlanta, Georgia, 30328

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Uptown Research Institute, LLC

    Chicago, Illinois, 60640

  • Community Research Management Associates, Inc.

    Cincinnati, Ohio, 45212

  • Patient Priority Clinical Sites LLC

    Cincinnati, Ohio, 45215

  • InSite Clinical Research LLC

    DeSoto, Texas, 75115

  • Behavioral Research Specialists LLC

    Glendale, California, 91206

  • Sun Valley Research Center

    Imperial, California, 92251

  • Preferred Research Partners

    Little Rock, Arkansas, 72211

  • Alliance for Research

    Long Beach, California, 90807

  • Pharmax Research Clinic Inc

    Miami, Florida, 33126

  • Innova Clinical Trials

    Miami, Florida, 33133

  • Eastside Comprehensive Medical Services

    New York, New York, 10128

  • Intend Research

    Norman, Oklahoma, 73069

  • Harmony Clinical Research Inc

    North Miami Beach, Florida, 33162

  • Excell Research Inc

    Oceanside, California, 92056

  • IPS Research Company

    Oklahoma City, Oklahoma, 73106

  • Medical Research Group of Central Florida

    Orange City, Florida, 32763

  • Synexus Research Orlando

    Orlando, Florida, 32806

  • Altea Research Institute

    Phoenix, Arizona, 85012

  • Phoenix Medical Research, Inc.

    Prairie Village, Kansas, 66206

  • Pillar Clinical Research, LLC

    Richardson, Texas, 75080

  • California Neuroscience Research Medical Group, Inc.

    Sherman Oaks, California, 91403

  • Stedman Clinical Trials

    Tampa, Florida, 33613

  • Compass Research LLC-Bioclinica Research

    The Villages, Florida, 32162

Other trials in United States

Ukraine11 sites

  • Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'

    Kharkiv, 61068

  • CNPE'Kherson Regional Institution of Mental Care'of Kherson Regional Council

    Kherson, 73488

  • Cnce 'Kyiv City Psychoneurological Hospital #2' of Executive Body of Kyiv City Council (Kcsa)

    Kyiv, 02192

  • Main Military Clinical Hospital of MDU

    Kyiv, 1133

  • Kyiv Clinical Railway Hospital #2 of the Branch Health Care Center of the PJSC Ukrainian Railway

    Kyiv, 3049

  • CNCE of the Lviv Regional Council 'Lviv Regional Clinical Psychiatric Hospital'

    Lviv, 79021

  • CI Odesa Regional Medical Center of Mental Health

    Odesa, 65014

  • CNCE Odesa regional psychiatric hospital #2 Odesa regional council

    Oleksandrivka, 67513

  • Poltava O.F. Maltsev RC Psychiatric Hospital Dept #9 (Ad-P Dept) HSEIU Ukrainian MSA

    Poltava, 36006

  • CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council'

    Smila, 20708

  • CI O.I. Yuschenko VRPsH Depts #7 & #10 M.I. Pyrogov VNMU

    Vinnytsia, 21005

Other trials in Ukraine

Argentina10 sites

  • Clínica Privada Banfield S.A

    Banfield, B1828CKR

  • STAT Research S A

    Buenos Aires, C1013AAB

  • NOVAIN Neurociencias Group

    Buenos Aires, C10154ABQ

  • Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales

    Buenos Aires, C1425AHQ

  • CEN Consultorios Especializados en Neurociencias

    Córdoba, 5000FJF

  • Instituto Medico DAMIC

    Córdoba, X5003DCE

  • Sanatorio Prof. Leon S. Morra

    Córdoba, X5009BIN

  • INSA Instituto de Neurociencias San Agustín

    La Plata, 1900

  • C I A P Centro de investigacion y Asistencia en Psiquiatria

    Rosario, 2000

  • Clinica Mayo de UMCB

    San Miguel de Tucumán, T4000IHE

Other trials in Argentina

South Korea8 sites

  • Chonnam National University Hospital

    Gwangju, 61469

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

  • Korea University Ansan Hospital

    Gyeonggi-do, 15355

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Samsung Medical Center

    Seoul, 06351

  • Chung-Ang University Hospital

    Seoul, 06973

  • Eulji General Hospital

    Seoul, 1830

Other trials in South Korea

Poland6 sites

  • Podlaskie Centrum Psychogeriatrii

    Bialystok, 15-756

  • Synexus Polska Sp. z o.o. Oddzial w Czestochowie

    Częstochowa, 42-202

  • Synexus Polska Sp z o o Oddzial w Katowicach

    Katowice, 40 040

  • Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

    Leszno, 64-100

  • Synexus Polska Sp z o o

    Lodz, 90 127

  • Centrum Medyczne Luxmed Sp z o o

    Lublin, 20 109

Other trials in Poland

Finland5 sites

  • Eira Hospital

    Helsinki, 150

  • Mederon LTD at ARTES

    Helsinki, 270

  • Savon Psykiatripalvelu

    Kuopio, 70110

  • Oulu Mentalcare Oy

    Oulu, 90100

  • Satakunnan Psykiatripalvelu

    Rauma, 26100

Other trials in Finland

Chile4 sites

  • Psicomed Estudios Medicos

    Antofagasta, 1270244

  • BioMedica Research Group

    Santiago, 7500710

  • CeCim - Centro de Estudios Clinicos e Investigacion Medica

    Santiago, 8320000

  • Hospital Dr Hernan Henriquez Aravena

    Temuco, 47811-51

Other trials in Chile

Malaysia4 sites

  • Hospital Kuala Lumpur

    Jalan Pahang, 50586

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Sibu

    Sibu, 96001

  • Sunway Medical Centre

    Sunway City, 47500

Other trials in Malaysia

Slovakia4 sites

  • Psychiatricka Ambulancia Mentum S.R.O.

    Bratislava, 82007

  • Psychiatricka Ambulancia Centrum Zdravia R.B.K. S.R.O.

    Svidník, 089 01

  • Crystal Comfort s.r.o.

    Vranov nad Topľou, 9301

  • BONA MEDIC, s.r.o.

    Zlaté Moravce, 95301

Other trials in Slovakia

Denmark2 sites

  • Ålborg Universitetshospital

    Aalborg, 9000

  • Psykiatrisk Center Nordsjaelland

    Hillerød, 3400

Other trials in Denmark

About this study

Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Seltorexant 20 mg as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy

The purpose of this study is to assess the efficacy of Seltorexant compared with placebo as 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 the detailed description

Major depressive disorder (MDD) is a common, serious, recurrent disorder. Seltorexant (JNJ-42847922) is a potent and selective antagonist of the human orexin-2 receptor (OX2R) that is being developed for the adjunctive treatment of MDDIS. The hypothesis for this study is that adjunctive treatment with seltorexant is superior to placebo in treating depressive symptoms, as measured by change in Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to Day 43 in adult and elderly participants with MDDIS who have had an inadequate response to treatment with a SSRI/SNRI. The study will be conducted in 3 phases: a screening phase (up to 30 days), a double-blind (DB) treatment phase (43 days), and a post treatment follow-up phase (7 to 14 days after DB treatment phase). Total duration of study is up to 12 weeks. Efficacy, safety, pharmacokinetics, and biomarkers will be assessed at specified time points during this study.

Being tested
Seltorexant, Placebo
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SeltorexantDrug

    Participants will receive Seltorexant tablets.

  • PlaceboDrug

    Participants will receive matching placebo tablets.

Study groups in NCT04532749
Study groupRoleWhat they receive
SeltorexantExperimentalParticipants will receive Seltorexant orally once daily from Day 1 to Day 42 (until the end of Week 6).
Receives: Drug: Seltorexant
PlaceboPlacebo comparatorParticipants will receive matching placebo tablets orally once daily from Day 1 to Day 42 (until the end of Week 6).
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to Day 43 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

    The MADRS was a clinician-rated scale designed to measure depression severity and detected changes due to antidepressant treatment. The scale consisted of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score was the sum of scores from individual question items, which ranged from 0 to 60, higher scores represented a more severe condition. Negative change in MADRS total score indicated improvement.

    Measured: Baseline (Day 1), Day 43

Secondary outcomes (5)

  1. Change From Baseline to Day 43 in the MADRS Without Sleep Item (MADRS-WOSI) Total Score

    The MADRS was a clinician-rated scale designed to measure depression severity and detected changes due to antidepressant treatment. MADRS-WOSI was defined as the full MADRS without the sleep item. The MADRS-WOSI scale consisted of 9 items (apparent sadness, reported sadness, inner tension, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). Higher scores represented a more severe condition. MADRS-WOSI total score was the sum of scores from individual question items, which ranged from 0 to 54, higher scores represented a more severe condition. Negative change in MADRS total score indicated improvement.

    Measured: Baseline (Day 1), Day 43

  2. Change From Baseline to Day 43 in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD; Short Form 8a) T-score

    PROMIS-SD Short Form 8a: static 8-item questionnaire, assessed self-perceptions of sleep initiation (2 items), quality of sleep (3 items), early morning feelings (2 items), worrying about sleep (1 item). Each question has 5 options ranged 1 to 5. The "direction" of responses was not same, sometimes "not at all" =more sleep disturbance; sometimes "not at all" =less sleep disturbance. Total raw score for short form with all questions answered was sum of values of response to each question, total score ranged 8 to 40. Lower scores=less sleep disturbance. Total raw score converted into T-score. T-score rescaled the raw score into standardized score with mean-50; SD-10. Negative changes in scores=improvement. Higher PROMIS T-score represents more concept measured. Negatively worded (like sleep disturbance), T-score of 60 was one SD worse than average. By comparison, T-score of 40 was one SD better than average. T-score of 50 or above was clinically significant level of sleep disturbance.

    Measured: Baseline (Day 1), Day 43

  3. Change From Baseline to Day 43 in the 6-item MADRS (MADRS-6) Total Score

    The 6-item MADRS was a clinician-administered scale designed to measure the core symptoms of depression severity and detected changes due to antidepressant intervention. It is a subset of MADRS (10-item). The MADRS-6 subscale score was the sum of scores for the following MADRS items: apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts. Each item was scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms), the overall score ranges from 0 to 36, higher scores represented a more severe condition. Negative changes in MADRS-6 total score indicate improvement.

    Measured: Baseline (Day 1), Day 43

  4. Percentage of Participants Who Achieved Response on Depressive Symptoms Scale Based on MADRS Total Score at Day 43

    Percentage of participants who achieved response on depressive symptoms scale based on MADRS total score at Day 43 were reported. Responders were defined as participants with a >=50 percent (%) improvement in the MADRS total score from baseline to a given timepoint. The MADRS was a clinician-rated scale designed to measure depression severity and detected changes due to antidepressant treatment. The scale consisted of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score was the sum of scores from individual question items, which ranged from 0 to 60, higher scores represented a more severe condition. Negative change in MADRS total score indicated improvement.

    Measured: At Day 43

  5. Change From Baseline to Day 43 in Patient Health Questionnaire, 9-item (PHQ-9) Total Score

    The PHQ-9 was a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) major depressive disorder (MDD) criteria. Each item was rated on a 4 point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses were summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 was categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). Negative changes in PHQ-9 total score indicated improvement.

    Measured: Baseline (Day 1), Day 43

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2020
  2. Study start15 Sep 2020
  3. Primary completion24 May 2022
  4. Study completion14 Jul 2022

Why it stopped: 42847922MDD3002 was stopped based on the interim analysis (IA) results as recommended by the Independent Data Monitoring Committee (IDMC)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
212 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04532749
Sponsor's protocol ID
CR108805
Other IDs
42847922MDD3002, 2020-000338-16
Status last verified
May 2025
First submitted
27 Aug 2020
Last updated
4 Jun 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical- trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Seltorexant in people with Depressive Disorder, Major, run by Janssen Research & Development, LLC at 80 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States, Ukraine, Argentina, South Korea, Poland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Day 43 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (time frame: Baseline (Day 1), Day 43). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04532749.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.

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