AzTrials
AzTrials

Depressive Disorder, MajorPhase 3NCT04513912

A Study of Seltorexant Compared to Quetiapine XR 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 and Quetiapine XR in people with Depressive Disorder, Major, run by Janssen Research & Development, LLC at 175 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the efficacy of seltorexant compared with quetiapine extended-release (XR) as adjunctive therapy to an antidepressant drug in treatment response in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current… 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 and Quetiapine XR
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
757 participants
Where
175 sitesin 15 countries
Study dates
15 Sep 2020to 3 Oct 2023
Phase
Phase 3
Are there results?
None posted in the registry

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 length 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 present other than insomnia, and overall good tolerability, as assessed by the Massachusetts General Hospital-Antidepressant Treatment Response Questionnaire (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 or above 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, 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 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 the following: physical 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] less than [<] 30 milliliter per minute [mL/min]); clinically significant or unstable cardiovascular, respiratory, gastrointestinal, neurologic, hematologic, rheumatologic, immunologic or endocrine disorders. uncontrolled Type 1 or Type 2 diabetes mellitus
  • 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 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, somatoform disorders
  • Has a history of moderate to severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening
  • 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

Trial locations and contacts

175 sites in 15 countries.

175 sites in 15 countries

United States75 sites

  • Synexus Clinical Research US Inc

    Atlanta, Georgia, 30328

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331

  • Pharmasite Research, Inc.

    Baltimore, Maryland, 21208

  • West Houston Clinical Research Service

    Bellaire, Texas, 77401

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • SPRI Clinical Trials, LLC

    Brooklyn, New York, 11235

  • University of Virginia

    Charlottesville, Virginia, 22903

  • Chicago Research Center

    Chicago, Illinois, 60634

  • University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience

    Cincinnati, Ohio, 45219

  • Alpine Research Organization

    Clinton, Utah, 84015

  • Proscience Research Group

    Culver City, California, 90230

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417

  • iResearch Atlanta LLC

    Decatur, Georgia, 30030

  • Moonshine Research Center, Inc

    Doral, Florida, 33166

  • Cedar Clinical Research

    Draper, Utah, 84020

  • Velocity Clinical Research, Inc.

    Durham, North Carolina, 27701

  • Pharmacology Research Institute

    Encino, California, 91316

  • Core Clinical Research

    Everett, Washington, 98201

  • North Texas Clinical Trials

    Fort Worth, Texas, 76104

  • Collaborative NeuroScience Network

    Garden Grove, California, 92845

  • Velocity Clinical Research, Hallandale Beach

    Hallandale, Florida, 33009

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Indago Research & Health Center Inc

    Hialeah, Florida, 33012

  • New Life Medical Research Center, Inc.

    Hialeah, Florida, 33012

  • Amedica Research Institute Inc

    Hialeah, Florida, 33013

  • Meridien Research

    Lakeland, Florida, 33803

  • Capstone Clinical Research

    Libertyville, Illinois, 60048

  • Alexian Brothers Health System

    Lisle, Illinois, 60532

  • Collaborative NeuroScience Network

    Long Beach, California, 90806

  • Pharmacology Research Institute

    Los Alamitos, California, 90720

  • CalNeuro Research

    Los Angeles, California, 90025

  • Hawkins Psychiatry, PC

    Mansfield, Texas, 76054

  • Psych Atlanta, P.C.

    Marietta, Georgia, 30060

  • Premier Clinical Research

    Miami, Florida, 33122

  • Global Medical Institutes

    Miami, Florida, 33125

  • Miami Jewish Health System

    Miami, Florida, 33137

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Baber Research Group

    Naperville, Illinois, 60563

  • BTC of New Bedford

    New Bedford, Massachusetts, 02740

  • Riverstar Research

    New Orleans, Louisiana, 70115

  • Fieve Clinical Research Inc

    New York, New York, 10017

  • The Medical Research Network, LLC

    New York, New York, 10128

  • Pharmacology Research Institute

    Newport Beach, California, 92660

  • Neuro Behavioral Clinical Research

    North Canton, Ohio, 44720

  • Psychiatric Care and Research Center (PCRC)

    O'Fallon, Missouri, 63368

  • Lemah Creek Clinical Research

    Oakbrook Terrace, Illinois, 60618

  • Sooner Clinical Research

    Oklahoma City, Oklahoma, 73112

  • Paradigm Research Professionals, LLC

    Oklahoma City, Oklahoma, 73118

  • NRC Research Institute

    Orange, California, 92868

  • Pacific Neuropsychiatric Specialists

    Orange, California, 92868

  • Clinical Neuroscience Solutions

    Orlando, Florida, 23801

  • Synexus Research Orlando

    Orlando, Florida, 32806

  • CNRI-Los Angeles, LLC

    Pico Rivera, California, 90660

  • Suburban Research Associates

    Pine Hill, Pennsylvania, 08021

  • Prospective Research Innovations Inc

    Rancho Cucamonga, California, 91730

  • Anderson Clinical Research

    Redlands, California, 92374

  • Finger Lakes Clinical Research

    Rochester, New York, 14618 1609

  • Boston Clinical Trials & Medical Research

    Roslindale, Massachusetts, 02135

  • University of California at San Diego

    San Diego, California, 92103

  • National Research Institute

    Santa Ana, California, 91704

  • CI Trials

    Santa Ana, California, 92705

  • CMB Clinical Trials

    Santee, California, 92071

  • Global Medical Institutes

    Scranton, Pennsylvania, 18503

  • Schuster Medical Research Institute

    Sherman Oaks, California, 91403

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

  • University of South Florida

    Tampa, Florida, 33612

  • Compass Research LLC-Bioclinica Research

    The Villages, Florida, 32162

  • Family Psychiatry of The Woodlands

    The Woodlands, Texas, 77381

  • Bio Behavioral Health

    Toms River, New Jersey, 08755

  • SW Biomedical Research LLC

    Tucson, Arizona, 85712

  • Pacific Clinical Research Medical Group

    Upland, California, 91786

  • Cary J. Kohlenberg, MD, SC, dba, IPC Research.

    Waukesha, Wisconsin, 53188

  • Ascension via Christi Research

    Wichita, Kansas, 67214

  • Grayline Research Center

    Wichita Falls, Texas, 76309

Other trials in United States

Argentina11 sites

  • CENydET - Centro Neurobiologico y de Stress Traumatico

    Buenos Aires, 1058AAJ

  • Hospital Italiano

    Buenos Aires, 1199

  • FunDaMos

    Buenos Aires, C1405BOA

  • Hospital Fleni

    Ciudad Autonoma Buenos Aires, C1428AQK

  • Fundacion Lennox

    Córdoba, 5000

  • Instituto Privado Kremer

    Córdoba, X5004AOA

  • Centro Medico Luquez

    Córdoba, X5006IKK

  • CENPIA

    La Plata, 1902

  • Clinica Privada de Salud Mental Santa Teresa de Ávila

    La Plata, Thanks

  • CENAIN

    Mendoza, M5502AWY

  • Clinica Mayo de UMCB

    San Miguel de Tucumán, 4000

Other trials in Argentina

Bulgaria11 sites

  • Medical Center Medconsult-Pleven

    Pleven, 5800

  • MC 'Hipokrat - N', EOOD

    Plovdiv, 4028

  • Mental Health Center - Rousse

    Rousse, 7003

  • Medical Center St. Naum

    Sofia, 1113

  • Medical Center Intermedica, OOD

    Sofia, 1680

  • MC 'Synexus Sofia' EOOD

    Sofia, 1784

  • MC 'Synexus Sofia' EOOD

    Stara Zagora, 6000

  • UMHAT Prof. Dr. St. Kirkovich AD

    Stara Zagora, 6003

  • State Psychiatric Hospital - Tzarev Brod

    Tzarev Brod, 9747

  • Diagnostic Consulting Center Mladost - M Varna

    Varna, 9020

  • Mental Health Center - Veliko Tarnovo EOOD

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Poland10 sites

  • Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski

    Bełchatów, 97-400

  • Wlokiennicza MED Specjalistyczna Praktyka Lekarska dr n.med. Tomasz Markowski

    Bialystok, 15-464

  • Przychodnia Srodmiescie SP. z o.o.

    Bydgoszcz, 85-080

  • Centrum Badan Klinicznych PI House sp z o o

    Gdansk, 80 546

  • Specjalistyczna Indywidualna Praktyka Lekarska

    Lodz, 90-009

  • CCBR - Lodz - PL

    Lodz, 90-368

  • Specjalistyczna Praktyka Lekarska Marek Domanski

    Lublin, 20-582

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

    Poznan, 60-702

  • Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp z o.o.

    Warsaw, 01 737

  • Instytut Psychiatrii I Neurologii

    Warsaw, 02 957

Other trials in Poland

Russia10 sites

  • Engels psychiatric hospital

    Engel's, 413124

  • Kemerovo Regional Clinical Psychiatric Hospital

    Kemerovo, 650036

  • GUZ Lipetsk Regional psychoneurological Hospital #1

    Lipetsk Region, 399313

  • JSC Scientific Centre of Personalized Medicine

    Moscow, 105082

  • FSI Moscow SRI of Psychiatry of Minzdravsocrazvitia

    Moscow, 107076

  • Moscow Scientific Research Institute of Psychiatry

    Moscow, 107076

  • Clinical Psychiatry Hospital n.a. N.N. Solodovnikov

    Omsk, 644070

  • St-Petersburg Bekhterev Psychoneurological Research Institute

    Saint Petersburg, 192019

  • Klinika StoLet Ltd

    Tomsk, 634009

  • Sverdlov Regional Psychiatric Clinical Hospital

    Yekaterinburg, 620030

Other trials in Russia

Serbia9 sites

  • General Hospital Acibadem Bel Medic

    Belgrade, 11000

  • General Hospital Euromedik

    Belgrade, 11000

  • Institute of Mental Health Serbia

    Belgrade, 11000

  • University Clinical Center of Serbia

    Belgrade, 11000

  • University Clinical Hospital Center Dr Dragisa Misovic- Dedi

    Belgrade, 11000

  • Special Neuropsychiatric Hospital Kovin

    Kovin, 26220

  • University Clinical Center Kragujevac

    Kragujevac, 34000

  • Clinical Center Nis

    Niš, 18000

  • Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi

    Novi Kneževac, 23330

Other trials in Serbia

Lithuania8 sites

  • Kaunas Silainiu Outpatient Clinic, Public Institution

    Kaunas, 48259

  • Republic Kaunas Hospital

    Kaunas, 53136

  • Romuvos Klinika, JSC

    Kaunas, LT-44279

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics

    Kaunas, LT-50009

  • Medical Center Puriena JSC

    Šilutė, 99176

  • Zirmunai Mental Health Center, Public Institution

    Vilnius, 09112

  • Antakalnis Psychiatric Consultation Centre, Public Institution

    Vilnius, 10204

  • Vilnius Mental Health Center

    Vilnius, 10309

Other trials in Lithuania

Slovakia8 sites

  • Psychomed-Svatosavsky, s.r.o.

    Banská Bystrica, 97401

  • Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach

    Bojnice, 97201

  • Epamed sro

    Košice, 040 11

  • Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu

    Liptovský Mikuláš, 03123

  • Psychiatricka Ambulancia Psycholine S.R.O.

    Rimavská Sobota, 97901

  • FN Trencin

    Trenčín, 91101

  • Pro mente sana s.r.o.

    Trenčín, 91108

  • Fakultna nemocnica s poliklinikou v Ziline

    Žilina, 1207

Other trials in Slovakia

Ukraine8 sites

  • MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association

    Hlevakha, 8631

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

    Kharkiv, 61068

  • Kyiv Territorial Medical Incorporation 'Psychiatry'

    Kyiv, 04080

  • Railway Clinical Hospital #1 of Kiev Railway station of DTGO 'South-Western Railway'

    Kyiv, 1030

  • Medical Center Health and Happy

    Kyiv, 1034

  • Mnpe 'Regional Clinical Psychiatric Hospital of Kirovohrad Regional Council'

    Nove, 25491

  • Ternopil RCCPH Depts of Psychiatry #2 (m) & Psychiatry #4 (f) Ternopil I.Ya. Gorbachevskyi SMU

    Ternopil, 46020

  • Zaporizhzhia Regional Clinical Hospital

    Zaporizhzhya, 69600

Other trials in Ukraine

Czechia7 sites

  • Psychiatricka ambulance Saint Anne s.r.o.

    Brno, 60200

  • NeuropsychiatrieHK, s.r.o.

    Hradec Králové, 500 09

  • A Shine S R O

    Pilsen, 301 00

  • Clintrial s r o

    Prague, 100 00

  • AD71 s.r.o.

    Prague, 10000

  • NeuropsychiatrieHK, s.r.o.

    Prague, 160 00

  • Institut Neuropsychiatricke pece

    Prague, 186 00

Other trials in Czechia

United Kingdom5 sites

  • Kingsway Hospital

    Derby, DE22 3LZ

  • Synexus

    Greater Manchester, M15 6SX

  • Garden Valleys Resource Centre

    Harrogate, HG1 2PW

  • Kings College Hospital NHS Trust

    London, SE5 8EF

  • Cornwall Partnership Foundation Trust

    Redruth, TR15 2SP

Other trials in United Kingdom

Latvia4 sites

  • The Mental Hospital of Jelgava Ģintermuiža - Psychiatry

    Jelgava, LV-3008

  • L. Keruze Practice in Psychiatry

    Liepāja, LV-3401

  • Hospital of Rezekne

    Outpatient Centre of Psychiatry, LV-4601

  • Riga Centre of Psychiatry and Narcology

    Riga, LV-1002

Other trials in Latvia

Malaysia4 sites

  • Hospital Raja Permaisuri Bainun

    Ipoh, 30990

  • Hospital Permai

    Johor Bahru, 81200

  • Hospital Pulau Pinang

    Pulau Pinang, 10990

  • Hospital Tuanku Jaafar

    Seremban, 70300

Other trials in Malaysia

Canada3 sites

  • Clinique Force Medic (GCP Trials)

    Montreal, Quebec, H1M 1B1

  • A.K. Munshi Medical Inc.

    Sydney, Nova Scotia, B1P 1E1

  • Canadian Phase Onward

    Toronto, Ontario, M3J 2C5

Other trials in Canada

Belgium2 sites

  • AZ Sint-Lucas

    Bruges, 8310

  • AZ Nikolaas

    Sint-Niklaas, 9100

Other trials in Belgium

About this study

Official title: Double-Blind, Randomized, Parallel-Group Study With Quetiapine Extended Release as Comparator 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 quetiapine extended-release (XR) as adjunctive therapy to an antidepressant drug in treatment response 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 seltorexant is superior to quetiapine XR in leading to a response after 26 weeks of treatment (greater than or equal to [>=] 50 percent [%] improvement on baseline Montgomery Asberg Depression Rating Scale [MADRS] total score), when administered as adjunctive treatment to an antidepressant in adult and elderly participants with MDDIS who have had an inadequate response to treatment with an SSRI/SNRI. The study will be conducted in 3 phases: a screening phase (up to 30 days), a double-blind (DB) treatment phase (26 weeks), and a post treatment follow-up phase (7 to 14 days after the end of DB treatment phase for all participants, and up to 196 days from baseline for participants who stop study treatment early). The total study duration for each participant will be approximately 32 weeks. Efficacy, safety, pharmacokinetics, and biomarkers will be assessed at specified time points during this study.

Being tested
Seltorexant, Matching placebo to Seltorexant, Quetiapine XR, Matching placebo to Quetiapine XR
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 over-encapsulated tablet orally.

  • Matching placebo to SeltorexantDrug

    Participants will receive placebo over-encapsulated tablet matching to seltorexant orally.

  • Quetiapine XRDrug

    Participants will receive quetiapine XR capsule orally.

  • Matching placebo to Quetiapine XRDrug

    Participants will receive placebo capsule matching to quetiapine XR orally.

Study groups in NCT04513912
Study groupRoleWhat they receive
SeltorexantExperimentalAdult participants will receive seltorexant once daily from Day 1-7 and together with matching placebo from Day 8 till Day 182. Elderly participants will receive seltorexant once daily from Day 1-3 and together with matching placebo from Day 4 till Day 182.
Receives: Drug: Seltorexant; Drug: Matching placebo to Seltorexant
Quetiapine Extended-Release (XR)Active comparatorAdult participants will receive quetiapine XR once daily from Day 1-2, followed by an increase in dose from Day 3-7, and from Day 8-14 together with matching placebo. After Day 14, quetiapine XR twice daily from Day 14 till Day 182. Elderly participants will receive quetiapine XR once daily from Day 1-3 and twice from Day 4-7, followed by an increase in dose once daily from Day 8-14 together with matching placebo. After Day 14 till Day 182, quetiapine XR will be adjusted by investigator based on the participant's clinical response and tolerability.
Receives: Drug: Quetiapine XR; Drug: Matching placebo to Quetiapine XR

What is being measured

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

  1. Percentage of Participants with Response (>=50 Percent improvement in MADRS total score from baseline) at Week 26

    Responders are defined as percentage of participants with greater than or equal to (>=) 50 percent (%) improvement in the montgomery-asberg depression rating scale (MADRS) total score from baseline. MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

    Measured: Week 26

Secondary outcomes (9)

  1. Change from baseline in Weight up to Week 26

    Change from baseline in weight will be reported.

    Measured: Baseline to Week 26

  2. Time to Study Drug Discontinuation for Potentially Treatment Related Reasons

    Time to discontinuation of study drug for potentially treatment related reasons will be reported. Potentially treatment related reasons are defined as all study drug discontinuations excluding the potentially non-treatment related discontinuations (eg, loss of insurance for antidepressant therapy, movement/travel out of the area, change of work-schedule being unable to accommodate visit schedule, family circumstances).

    Measured: Up to Week 26

  3. Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

    MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

    Measured: Baseline to Week 26

  4. Change from Baseline in MADRS-6 Total Score

    The MADRS-6 scale is a clinician-administered questionnaire used to measure the severity of MDD symptoms. The MADRS-6 scale is a subset of the MADRS-10 scale, comprised of the following individual questionnaire items: Apparent Sadness, Reported Sadness, Inner Tension, Lassitude, Inability to Feel, and Pessimistic Thoughts. Scores range from 0 (no apparent symptoms) to 36 (most severe symptoms).

    Measured: Baseline to Week 26

  5. Change from Baseline in the MADRS Without Sleep Item (MADRS-WOSI) Total Score

    The MADRS is a 10-item clinician-rated instrument for evaluating severity of symptoms of depression. Each item is rated on a scale from 0 to 6, with higher scores indicating greater symptom severity. MADRS-WOSI considered 9 of the 10 MADRS items, excluding "reduced sleep" item. The total score ranged from 0 to 54, with higher scores corresponding to greater symptom severity.

    Measured: Baseline to Week 26

  6. Change from Baseline in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score

    The PHQ-9 is 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 is 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 are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms.

    Measured: Baseline to Week 26

  7. Percentage of Participants with Remission (MADRS Total Score less than or equal to (<=) 12) at Week 26

    Percentage of participants with remission (MADRS total Score <=12) will be reported.

    Measured: Week 26

  8. Percentage of Participants with a >=50 Percent Improvement in MADRS Total Score and MADRS <=18 at Week 26

    Percentage of participants with a >=50 percent improvement in MADRS total score and MADRS <=18 at Week 26.

    Measured: Week 26

  9. Percentage of Participants with Weight Increase >=7 Percent from Baseline at Week 26

    Percentage of participants with weight increase >=7 percent from baseline will be reported.

    Measured: Week 26

Timeline

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

  1. First posted14 Aug 2020
  2. Study start15 Sep 2020
  3. Primary completion3 Oct 2023
  4. Study completion3 Oct 2023

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
757 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04513912
Sponsor's protocol ID
CR108810
Other IDs
42847922MDD3005, 2020-000341-14
Status last verified
Aug 2025
First submitted
13 Aug 2020
Last updated
13 Aug 2025
Results posted
No
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 and Quetiapine XR in people with Depressive Disorder, Major, run by Janssen Research & Development, LLC at 175 sites in 15 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 175 sites in United States, Argentina, Bulgaria, Poland, Russia and 10 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of Participants with Response (>=50 Percent improvement in MADRS total score from baseline) at Week 26 (time frame: Week 26). 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 NCT04513912.

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 13 Aug 2025.

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