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

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).

Study Overview

• Status: Completed
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Drug: Seltorexant; Drug: Matching placebo to Seltorexant; Drug: Quetiapine XR; Drug: Matching placebo to Quetiapine XR

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.

• Study Type: Interventional
• Enrollment (Actual): 757
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1058AAJ
    • CENydET - Centro Neurobiologico y de Stress Traumatico
  • Ciudad Autonoma Buenos Aires, Argentina, C1428AQK
    • Hospital Fleni
  • Ciudad Autonoma de Buenos Aires, Argentina, C1405BOA
    • FunDaMos
  • Ciudad Autonoma de Buenos Aires, Argentina, 1199
    • Hospital Italiano
  • Cordoba, Argentina, 5000
    • Fundacion Lennox
  • Cordoba, Argentina, X5004AOA
    • Instituto Privado Kremer
  • Cordoba, Argentina, X5006IKK
    • Centro Medico Luquez
  • La Plata, Argentina, Thanks
    • Clinica Privada de Salud Mental Santa Teresa de Ávila
  • La Plata, Argentina, 1902
    • CENPIA
  • Mendoza, Argentina, M5502AWY
    • CENAIN
  • San Miguel de Tucuman, Argentina, 4000
    • Clinica Mayo de UMCB
• Belgium
  • Brugge, Belgium, 8310
    • AZ Sint-Lucas
  • Sint-Niklaas, Belgium, 9100
    • AZ Nikolaas
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Medical Center Medconsult-Pleven
  • Plovdiv, Bulgaria, 4028
    • MC 'Hipokrat - N', EOOD
  • Ruse, Bulgaria, 7003
    • Mental Health Center - Rousse
  • Sofia, Bulgaria, 1680
    • Medical Center Intermedica, OOD
  • Sofia, Bulgaria, 1113
    • Medical Center St. Naum
  • Sofia, Bulgaria, 1784
    • MC 'Synexus Sofia' EOOD
  • Stara Zagora, Bulgaria, 6003
    • UMHAT Prof. Dr. St. Kirkovich AD
  • Stara Zagora, Bulgaria, 6000
    • MC 'Synexus Sofia' EOOD
  • Tzarev Brod, Bulgaria, 9747
    • State Psychiatric Hospital - Tzarev Brod
  • Varna, Bulgaria, 9020
    • Diagnostic Consulting Center Mladost - M Varna
  • Veliko Tarnovo, Bulgaria, 5000
    • Mental Health Center - Veliko Tarnovo EOOD
• Canada
  • Nova Scotia
    • Sydney, Nova Scotia, Canada, B1P 1E1
      • A.K. Munshi Medical Inc.
  • Ontario
    • Toronto, Ontario, Canada, M3J 2C5
      • Canadian Phase Onward
  • Quebec
    • Montreal, Quebec, Canada, H1M 1B1
      • Clinique Force Medic (GCP Trials)
• Czechia
  • Brno, Czechia, 60200
    • Psychiatricka ambulance Saint Anne s.r.o.
  • Hradec Kralove, Czechia, 500 09
    • NeuropsychiatrieHK, s.r.o.
  • Plzen, Czechia, 301 00
    • A Shine S R O
  • Praha 10, Czechia, 10000
    • Ad71 S.R.O.
  • Praha 10, Czechia, 100 00
    • Clintrial s r o
  • Praha 6, Czechia, 160 00
    • NeuropsychiatrieHK, s.r.o.
  • Praha 8, Czechia, 186 00
    • Institut neuropsychiatricke pece
• Latvia
  • Jelgava, Latvia, LV-3008
    • The Mental Hospital of Jelgava Ģintermuiža - Psychiatry
  • Liepaja, Latvia, LV-3401
    • L. Keruze Practice in Psychiatry
  • Outpatient Centre Of Psychiatry, Latvia, LV-4601
    • Hospital of Rezekne
  • Riga, Latvia, LV-1002
    • Riga Centre of Psychiatry and Narcology
• Lithuania
  • Kaunas, Lithuania, LT-50009
    • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
  • Kaunas, Lithuania, 48259
    • Kaunas Silainiu Outpatient Clinic, Public Institution
  • Kaunas, Lithuania, 53136
    • Republic Kaunas Hospital
  • Kaunas, Lithuania, LT-44279
    • Romuvos Klinika, JSC
  • Silute, Lithuania, 99176
    • Medical Center Puriena JSC
  • Vilnius, Lithuania, 09112
    • Zirmunai Mental Health Center, Public Institution
  • Vilnius, Lithuania, 10309
    • Vilnius Mental Health Center
  • Vilnius, Lithuania, 10204
    • Antakalnis Psychiatric Consultation Centre, Public Institution
• Malaysia
  • Ipoh, Malaysia, 30990
    • Hospital Raja Permaisuri Bainun
  • Johor Bahru, Malaysia, 81200
    • Hospital Permai
  • Pulau Pinang, Malaysia, 10990
    • Hospital Pulau Pinang
  • Seremban, Malaysia, 70300
    • Hospital Tuanku Jaafar
• Poland
  • Belchatow, Poland, 97-400
    • Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski
  • Bialystok, Poland, 15-464
    • Wlokiennicza MED Specjalistyczna Praktyka Lekarska dr n.med. Tomasz Markowski
  • Bydgoszcz, Poland, 85-080
    • Przychodnia Srodmiescie SP. z o.o.
  • Gdansk, Poland, 80 546
    • Centrum Badan Klinicznych PI House sp z o o
  • Lodz, Poland, 90-368
    • CCBR - Lodz - PL
  • Lodz, Poland, 90-009
    • Specjalistyczna Indywidualna Praktyka Lekarska
  • Lublin, Poland, 20-582
    • Specjalistyczna Praktyka Lekarska Marek Domanski
  • Poznan, Poland, 60-702
    • Synexus Polska Sp. z.o.o. Oddzial w Poznaniu
  • Warsaw, Poland, 02 957
    • Instytut Psychiatrii i Neurologii
  • Warszawa, Poland, 01 737
    • Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp z o.o.
• Russian Federation
  • Ekaterinburg, Russian Federation, 620030
    • Sverdlov Regional Psychiatric Clinical Hospital
  • Engels, Russian Federation, 413124
    • Engels psychiatric hospital
  • Kemerovo, Russian Federation, 650036
    • Kemerovo Regional Clinical Psychiatric Hospital
  • Lipetsk Region, Russian Federation, 399313
    • GUZ Lipetsk Regional psychoneurological Hospital #1
  • Moscow, Russian Federation, 107076
    • Moscow Scientific Research Institute of Psychiatry
  • Moscow, Russian Federation, 107076
    • FSI Moscow SRI of Psychiatry of Minzdravsocrazvitia
  • Moscow, Russian Federation, 105082
    • JSC Scientific Centre of Personalized Medicine
  • Omsk, Russian Federation, 644070
    • Clinical Psychiatry Hospital n.a. N.N. Solodovnikov
  • St. Petersburg, Russian Federation, 192019
    • St-Petersburg Bekhterev Psychoneurological Research Institute
  • Tomsk, Russian Federation, 634009
    • Klinika StoLet Ltd
• Serbia
  • Belgrade, Serbia, 11000
    • University Clinical Center of Serbia
  • Belgrade, Serbia, 11000
    • General Hospital Euromedik
  • Belgrade, Serbia, 11000
    • University Clinical Hospital Center Dr Dragisa Misovic- Dedi
  • Belgrade, Serbia, 11000
    • General Hospital Acibadem Bel Medic
  • Belgrade, Serbia, 11000
    • Institute of Mental Health Serbia
  • Kovin, Serbia, 26220
    • Special Neuropsychiatric Hospital Kovin
  • Kragujevac, Serbia, 34000
    • University Clinical Center Kragujevac
  • Nis, Serbia, 18000
    • Clinical Center Nis
  • Novi Knezevac, Serbia, 23330
    • Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi
• Slovakia
  • Banska Bystrica, Slovakia, 97401
    • Psychomed-Svatosavsky, s.r.o.
  • Bojnice, Slovakia, 97201
    • Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach
  • Koshice, Slovakia, 040 11
    • Epamed sro
  • Liptovsky Mikulas, Slovakia, 03123
    • Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu
  • Rimavska Sobota, Slovakia, 97901
    • Psychiatricka Ambulancia Psycholine S.R.O.
  • Trencin, Slovakia, 91101
    • FN Trencin
  • Trencin, Slovakia, 91108
    • Pro mente sana s.r.o.
  • Zilina, Slovakia, 1207
    • Fakultna nemocnica s poliklinikou v Ziline
• Ukraine
  • Glevakha, Ukraine, 8631
    • MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association
  • Kharkiv, Ukraine, 61068
    • Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'
  • Kyiv, Ukraine, 04080
    • Kyiv Territorial Medical Incorporation 'Psychiatry'
  • Kyiv, Ukraine, 1030
    • Railway Clinical Hospital #1 of Kiev Railway station of DTGO 'South-Western Railway'
  • Kyiv, Ukraine, 1034
    • Medical Center Health and Happy
  • Nove, Ukraine, 25491
    • Mnpe 'Regional Clinical Psychiatric Hospital of Kirovohrad Regional Council'
  • Ternopil, Ukraine, 46020
    • Ternopil RCCPH Depts of Psychiatry #2 (m) & Psychiatry #4 (f) Ternopil I.Ya. Gorbachevskyi SMU
  • Zaporizhzhia, Ukraine, 69600
    • Zaporizhzhia Regional Clinical Hospital
• United Kingdom
  • Derby, United Kingdom, DE22 3LZ
    • Kingsway Hospital
  • Greater Manchester, United Kingdom, M15 6SX
    • Synexus
  • Harrogate, United Kingdom, HG1 2PW
    • Garden Valleys Resource Centre
  • London, United Kingdom, SE5 8EF
    • Kings College Hospital NHS Trust
  • Redruth, United Kingdom, TR15 2SP
    • Cornwall Partnership Foundation Trust
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • Arizona
    • Tucson, Arizona, United States, 85712
      • SW Biomedical Research LLC
  • California
    • Culver City, California, United States, 90230
      • Proscience Research Group
    • Encino, California, United States, 91316
      • Pharmacology Research Institute
    • Garden Grove, California, United States, 92845
      • Collaborative Neuroscience Network
    • Long Beach, California, United States, 90806
      • Collaborative Neuroscience Network
    • Los Alamitos, California, United States, 90720
      • Pharmacology Research Institute
    • Los Angeles, California, United States, 90025
      • CalNeuro Research
    • Newport Beach, California, United States, 92660
      • Pharmacology Research Institute
    • Orange, California, United States, 92868
      • NRC Research Institute
    • Orange, California, United States, 92868
      • Pacific Neuropsychiatric Specialists
    • Pico Rivera, California, United States, 90660
      • CNRI-Los Angeles, LLC
    • Rancho Cucamonga, California, United States, 91730
      • Prospective Research Innovations Inc
    • Redlands, California, United States, 92374
      • Anderson Clinical Research
    • San Diego, California, United States, 92103
      • University of California at San Diego
    • Santa Ana, California, United States, 92705
      • CI Trials
    • Santa Ana, California, United States, 91704
      • National Research Institute
    • Santee, California, United States, 92071
      • CMB Clinical Trials
    • Sherman Oaks, California, United States, 91403
      • Schuster Medical Research Institute
    • Upland, California, United States, 91786
      • Pacific Clinical Research Medical Group
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
  • Florida
    • Doral, Florida, United States, 33166
      • Moonshine Research Center, Inc
    • Hallandale Beach, Florida, United States, 33009
      • Velocity Clinical Research, Hallandale Beach
    • Hialeah, Florida, United States, 33012
      • Indago Research & Health Center Inc
    • Hialeah, Florida, United States, 33012
      • New Life Medical Research Center, Inc.
    • Hialeah, Florida, United States, 33013
      • Amedica Research Institute Inc
    • Lakeland, Florida, United States, 33803
      • Meridien Research
    • Miami, Florida, United States, 33122
      • Premier Clinical Research
    • Miami, Florida, United States, 33125
      • Global Medical Institutes
    • Miami, Florida, United States, 33137
      • Miami Jewish Health System
    • Orlando, Florida, United States, 32806
      • Synexus Research Orlando
    • Orlando, Florida, United States, 23801
      • Clinical Neuroscience Solutions
    • Tampa, Florida, United States, 33612
      • University Of South Florida
    • The Villages, Florida, United States, 32162
      • Compass Research LLC-Bioclinica Research
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
    • Atlanta, Georgia, United States, 30328
      • Synexus Clinical Research US Inc
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta LLC
    • Marietta, Georgia, United States, 30060
      • Psych Atlanta, P.C.
  • Illinois
    • Chicago, Illinois, United States, 60634
      • Chicago Research Center
    • Libertyville, Illinois, United States, 60048
      • Capstone Clinical Research
    • Lisle, Illinois, United States, 60532
      • Alexian Brothers Health System
    • Naperville, Illinois, United States, 60563
      • Baber Research Group
    • Oakbrook Terrace, Illinois, United States, 60618
      • Lemah Creek Clinical Research
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Ascension via Christi Research
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Riverstar Research
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Pharmasite Research, Inc.
  • Massachusetts
    • New Bedford, Massachusetts, United States, 02740
      • Btc of New Bedford
    • Roslindale, Massachusetts, United States, 02135
      • Boston Clinical Trials & Medical Research
  • Missouri
    • O'Fallon, Missouri, United States, 63368
      • Psychiatric Care and Research Center (PCRC)
  • New Jersey
    • Toms River, New Jersey, United States, 08755
      • Bio Behavioral Health
  • New York
    • Brooklyn, New York, United States, 11235
      • SPRI Clinical Trials, LLC
    • New York, New York, United States, 10128
      • The Medical Research Network, LLC
    • New York, New York, United States, 10017
      • Fieve Clinical Research Inc
    • Rochester, New York, United States, 14618 1609
      • Finger Lakes Clinical Research
    • Staten Island, New York, United States, 10312
      • Richmond Behavioral Associates
  • North Carolina
    • Durham, North Carolina, United States, 27701
      • Velocity Clinical Research, Inc.
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research Center
    • North Canton, Ohio, United States, 44720
      • Neuro Behavioral Clinical Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Sooner Clinical Research
    • Oklahoma City, Oklahoma, United States, 73118
      • Paradigm Research Professionals, LLC
  • Pennsylvania
    • Pine Hill, Pennsylvania, United States, 08021
      • Suburban Research Associates
    • Scranton, Pennsylvania, United States, 18503
      • Global Medical Institutes
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center
  • Texas
    • Bellaire, Texas, United States, 77401
      • West Houston Clinical Research Service
    • Fort Worth, Texas, United States, 76104
      • North Texas Clinical Trials
    • Mansfield, Texas, United States, 76054
      • Hawkins Psychiatry, PC
    • The Woodlands, Texas, United States, 77381
      • Family Psychiatry of The Woodlands
    • Wichita Falls, Texas, United States, 76309
      • Grayline Research Center
  • Utah
    • Clinton, Utah, United States, 84015
      • Alpine Research Organization
    • Draper, Utah, United States, 84020
      • Cedar Clinical Research
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Everett, Washington, United States, 98201
      • Core Clinical Research
  • Wisconsin
    • Waukesha, Wisconsin, United States, 53188
      • Cary J. Kohlenberg, MD, SC, dba, IPC Research.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Seltorexant; Adult 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.	Drug: Seltorexant; Participants will receive seltorexant over-encapsulated tablet orally.; Drug: Matching placebo to Seltorexant; Participants will receive placebo over-encapsulated tablet matching to seltorexant orally.
Active Comparator: Quetiapine Extended-Release (XR); Adult 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.	Drug: Quetiapine XR; Participants will receive quetiapine XR capsule orally.; Drug: Matching placebo to Quetiapine XR; Participants will receive placebo capsule matching to quetiapine XR orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Weight up to Week 26	Change from baseline in weight will be reported.	Baseline to Week 26
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).	Up to Week 26
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.	Baseline to Week 26
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).	Baseline to Week 26
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.	Baseline to Week 26
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.	Baseline to Week 26
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.	Week 26
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.	Week 26
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.	Week 26

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): October 3, 2023
• Study Completion (Actual): October 3, 2023

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 13, 2020
• First Posted (Actual): August 14, 2020

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antipsychotic Agents; Quetiapine Fumarate
• Other Study ID Numbers: CR108810; 42847922MDD3005 (Other Identifier: Janssen Research & Development, LLC); 2020-000341-14 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No