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
3 other identifiers
interventional
757
15 countries
175
Brief 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 antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2020
Typical duration for phase_3
175 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2020
CompletedFirst Posted
Study publicly available on registry
August 14, 2020
CompletedStudy Start
First participant enrolled
September 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 3, 2023
CompletedAugust 13, 2025
August 1, 2025
3 years
August 13, 2020
August 11, 2025
Conditions
Outcome Measures
Primary Outcomes (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.
Week 26
Secondary Outcomes (9)
Change from baseline in Weight up to Week 26
Baseline to Week 26
Time to Study Drug Discontinuation for Potentially Treatment Related Reasons
Up to Week 26
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Baseline to Week 26
Change from Baseline in MADRS-6 Total Score
Baseline to Week 26
Change from Baseline in the MADRS Without Sleep Item (MADRS-WOSI) Total Score
Baseline to Week 26
- +4 more secondary outcomes
Study Arms (2)
Seltorexant
EXPERIMENTALAdult 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.
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.
Interventions
Participants will receive placebo over-encapsulated tablet matching to seltorexant orally.
Participants will receive quetiapine XR capsule orally.
Participants will receive placebo capsule matching to quetiapine XR orally.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (175)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
SW Biomedical Research LLC
Tucson, Arizona, 85712, United States
Proscience Research Group
Culver City, California, 90230, United States
Pharmacology Research Institute
Encino, California, 91316, United States
Collaborative NeuroScience Network
Garden Grove, California, 92845, United States
Collaborative NeuroScience Network
Long Beach, California, 90806, United States
Pharmacology Research Institute
Los Alamitos, California, 90720, United States
CalNeuro Research
Los Angeles, California, 90025, United States
Pharmacology Research Institute
Newport Beach, California, 92660, United States
NRC Research Institute
Orange, California, 92868, United States
Pacific Neuropsychiatric Specialists
Orange, California, 92868, United States
CNRI-Los Angeles, LLC
Pico Rivera, California, 90660, United States
Prospective Research Innovations Inc
Rancho Cucamonga, California, 91730, United States
Anderson Clinical Research
Redlands, California, 92374, United States
University of California at San Diego
San Diego, California, 92103, United States
National Research Institute
Santa Ana, California, 91704, United States
CI Trials
Santa Ana, California, 92705, United States
CMB Clinical Trials
Santee, California, 92071, United States
Schuster Medical Research Institute
Sherman Oaks, California, 91403, United States
Pacific Clinical Research Medical Group
Upland, California, 91786, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Moonshine Research Center, Inc
Doral, Florida, 33166, United States
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, 33009, United States
Indago Research & Health Center Inc
Hialeah, Florida, 33012, United States
New Life Medical Research Center, Inc.
Hialeah, Florida, 33012, United States
Amedica Research Institute Inc
Hialeah, Florida, 33013, United States
Meridien Research
Lakeland, Florida, 33803, United States
Premier Clinical Research
Miami, Florida, 33122, United States
Global Medical Institutes
Miami, Florida, 33125, United States
Miami Jewish Health System
Miami, Florida, 33137, United States
Clinical Neuroscience Solutions
Orlando, Florida, 23801, United States
Synexus Research Orlando
Orlando, Florida, 32806, United States
University of South Florida
Tampa, Florida, 33612, United States
Compass Research LLC-Bioclinica Research
The Villages, Florida, 32162, United States
Synexus Clinical Research US Inc
Atlanta, Georgia, 30328, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
iResearch Atlanta LLC
Decatur, Georgia, 30030, United States
Psych Atlanta, P.C.
Marietta, Georgia, 30060, United States
Chicago Research Center
Chicago, Illinois, 60634, United States
Capstone Clinical Research
Libertyville, Illinois, 60048, United States
Alexian Brothers Health System
Lisle, Illinois, 60532, United States
Baber Research Group
Naperville, Illinois, 60563, United States
Lemah Creek Clinical Research
Oakbrook Terrace, Illinois, 60618, United States
Ascension via Christi Research
Wichita, Kansas, 67214, United States
Riverstar Research
New Orleans, Louisiana, 70115, United States
Pharmasite Research, Inc.
Baltimore, Maryland, 21208, United States
BTC of New Bedford
New Bedford, Massachusetts, 02740, United States
Boston Clinical Trials & Medical Research
Roslindale, Massachusetts, 02135, United States
Psychiatric Care and Research Center (PCRC)
O'Fallon, Missouri, 63368, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235, United States
Fieve Clinical Research Inc
New York, New York, 10017, United States
The Medical Research Network, LLC
New York, New York, 10128, United States
Finger Lakes Clinical Research
Rochester, New York, 14618 1609, United States
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
Velocity Clinical Research, Inc.
Durham, North Carolina, 27701, United States
University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience
Cincinnati, Ohio, 45219, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
Neuro Behavioral Clinical Research
North Canton, Ohio, 44720, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112, United States
Paradigm Research Professionals, LLC
Oklahoma City, Oklahoma, 73118, United States
Suburban Research Associates
Pine Hill, Pennsylvania, 08021, United States
Global Medical Institutes
Scranton, Pennsylvania, 18503, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
West Houston Clinical Research Service
Bellaire, Texas, 77401, United States
North Texas Clinical Trials
Fort Worth, Texas, 76104, United States
Hawkins Psychiatry, PC
Mansfield, Texas, 76054, United States
Family Psychiatry of The Woodlands
The Woodlands, Texas, 77381, United States
Grayline Research Center
Wichita Falls, Texas, 76309, United States
Alpine Research Organization
Clinton, Utah, 84015, United States
Cedar Clinical Research
Draper, Utah, 84020, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Core Clinical Research
Everett, Washington, 98201, United States
Cary J. Kohlenberg, MD, SC, dba, IPC Research.
Waukesha, Wisconsin, 53188, United States
CENydET - Centro Neurobiologico y de Stress Traumatico
Buenos Aires, 1058AAJ, Argentina
Hospital Italiano
Buenos Aires, 1199, Argentina
FunDaMos
Buenos Aires, C1405BOA, Argentina
Hospital Fleni
Ciudad Autonoma Buenos Aires, C1428AQK, Argentina
Fundacion Lennox
Córdoba, 5000, Argentina
Instituto Privado Kremer
Córdoba, X5004AOA, Argentina
Centro Medico Luquez
Córdoba, X5006IKK, Argentina
CENPIA
La Plata, 1902, Argentina
Clinica Privada de Salud Mental Santa Teresa de Ávila
La Plata, Thanks, Argentina
CENAIN
Mendoza, M5502AWY, Argentina
Clinica Mayo de UMCB
San Miguel de Tucumán, 4000, Argentina
AZ Sint-Lucas
Bruges, 8310, Belgium
AZ Nikolaas
Sint-Niklaas, 9100, Belgium
Medical Center Medconsult-Pleven
Pleven, 5800, Bulgaria
MC 'Hipokrat - N', EOOD
Plovdiv, 4028, Bulgaria
Mental Health Center - Rousse
Rousse, 7003, Bulgaria
Medical Center St. Naum
Sofia, 1113, Bulgaria
Medical Center Intermedica, OOD
Sofia, 1680, Bulgaria
MC 'Synexus Sofia' EOOD
Sofia, 1784, Bulgaria
MC 'Synexus Sofia' EOOD
Stara Zagora, 6000, Bulgaria
UMHAT Prof. Dr. St. Kirkovich AD
Stara Zagora, 6003, Bulgaria
State Psychiatric Hospital - Tzarev Brod
Tzarev Brod, 9747, Bulgaria
Diagnostic Consulting Center Mladost - M Varna
Varna, 9020, Bulgaria
Mental Health Center - Veliko Tarnovo EOOD
Veliko Tarnovo, 5000, Bulgaria
A.K. Munshi Medical Inc.
Sydney, Nova Scotia, B1P 1E1, Canada
Canadian Phase Onward
Toronto, Ontario, M3J 2C5, Canada
Clinique Force Medic (GCP Trials)
Montreal, Quebec, H1M 1B1, Canada
Psychiatricka ambulance Saint Anne s.r.o.
Brno, 60200, Czechia
NeuropsychiatrieHK, s.r.o.
Hradec Králové, 500 09, Czechia
A Shine S R O
Pilsen, 301 00, Czechia
Clintrial s r o
Prague, 100 00, Czechia
AD71 s.r.o.
Prague, 10000, Czechia
NeuropsychiatrieHK, s.r.o.
Prague, 160 00, Czechia
Institut Neuropsychiatricke pece
Prague, 186 00, Czechia
The Mental Hospital of Jelgava Ģintermuiža - Psychiatry
Jelgava, LV-3008, Latvia
L. Keruze Practice in Psychiatry
Liepāja, LV-3401, Latvia
Hospital of Rezekne
Outpatient Centre of Psychiatry, LV-4601, Latvia
Riga Centre of Psychiatry and Narcology
Riga, LV-1002, Latvia
Kaunas Silainiu Outpatient Clinic, Public Institution
Kaunas, 48259, Lithuania
Republic Kaunas Hospital
Kaunas, 53136, Lithuania
Romuvos Klinika, JSC
Kaunas, LT-44279, Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, LT-50009, Lithuania
Medical Center Puriena JSC
Šilutė, 99176, Lithuania
Zirmunai Mental Health Center, Public Institution
Vilnius, 09112, Lithuania
Antakalnis Psychiatric Consultation Centre, Public Institution
Vilnius, 10204, Lithuania
Vilnius Mental Health Center
Vilnius, 10309, Lithuania
Hospital Raja Permaisuri Bainun
Ipoh, 30990, Malaysia
Hospital Permai
Johor Bahru, 81200, Malaysia
Hospital Pulau Pinang
Pulau Pinang, 10990, Malaysia
Hospital Tuanku Jaafar
Seremban, 70300, Malaysia
Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski
Bełchatów, 97-400, Poland
Wlokiennicza MED Specjalistyczna Praktyka Lekarska dr n.med. Tomasz Markowski
Bialystok, 15-464, Poland
Przychodnia Srodmiescie SP. z o.o.
Bydgoszcz, 85-080, Poland
Centrum Badan Klinicznych PI House sp z o o
Gdansk, 80 546, Poland
Specjalistyczna Indywidualna Praktyka Lekarska
Lodz, 90-009, Poland
CCBR - Lodz - PL
Lodz, 90-368, Poland
Specjalistyczna Praktyka Lekarska Marek Domanski
Lublin, 20-582, Poland
Synexus Polska Sp. z.o.o. Oddzial w Poznaniu
Poznan, 60-702, Poland
Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp z o.o.
Warsaw, 01 737, Poland
Instytut Psychiatrii I Neurologii
Warsaw, 02 957, Poland
Engels psychiatric hospital
Engel's, 413124, Russia
Kemerovo Regional Clinical Psychiatric Hospital
Kemerovo, 650036, Russia
GUZ Lipetsk Regional psychoneurological Hospital #1
Lipetsk Region, 399313, Russia
JSC Scientific Centre of Personalized Medicine
Moscow, 105082, Russia
FSI Moscow SRI of Psychiatry of Minzdravsocrazvitia
Moscow, 107076, Russia
Moscow Scientific Research Institute of Psychiatry
Moscow, 107076, Russia
Clinical Psychiatry Hospital n.a. N.N. Solodovnikov
Omsk, 644070, Russia
St-Petersburg Bekhterev Psychoneurological Research Institute
Saint Petersburg, 192019, Russia
Klinika StoLet Ltd
Tomsk, 634009, Russia
Sverdlov Regional Psychiatric Clinical Hospital
Yekaterinburg, 620030, Russia
General Hospital Acibadem Bel Medic
Belgrade, 11000, Serbia
General Hospital Euromedik
Belgrade, 11000, Serbia
Institute of Mental Health Serbia
Belgrade, 11000, Serbia
University Clinical Center of Serbia
Belgrade, 11000, Serbia
University Clinical Hospital Center Dr Dragisa Misovic- Dedi
Belgrade, 11000, Serbia
Special Neuropsychiatric Hospital Kovin
Kovin, 26220, Serbia
University Clinical Center Kragujevac
Kragujevac, 34000, Serbia
Clinical Center Nis
Niš, 18000, Serbia
Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi
Novi Kneževac, 23330, Serbia
Psychomed-Svatosavsky, s.r.o.
Banská Bystrica, 97401, Slovakia
Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach
Bojnice, 97201, Slovakia
Epamed sro
Košice, 040 11, Slovakia
Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu
Liptovský Mikuláš, 03123, Slovakia
Psychiatricka Ambulancia Psycholine S.R.O.
Rimavská Sobota, 97901, Slovakia
FN Trencin
Trenčín, 91101, Slovakia
Pro mente sana s.r.o.
Trenčín, 91108, Slovakia
Fakultna nemocnica s poliklinikou v Ziline
Žilina, 1207, Slovakia
MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association
Hlevakha, 8631, Ukraine
Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'
Kharkiv, 61068, Ukraine
Kyiv Territorial Medical Incorporation 'Psychiatry'
Kyiv, 04080, Ukraine
Railway Clinical Hospital #1 of Kiev Railway station of DTGO 'South-Western Railway'
Kyiv, 1030, Ukraine
Medical Center Health and Happy
Kyiv, 1034, Ukraine
Mnpe 'Regional Clinical Psychiatric Hospital of Kirovohrad Regional Council'
Nove, 25491, Ukraine
Ternopil RCCPH Depts of Psychiatry #2 (m) & Psychiatry #4 (f) Ternopil I.Ya. Gorbachevskyi SMU
Ternopil, 46020, Ukraine
Zaporizhzhia Regional Clinical Hospital
Zaporizhzhia, 69600, Ukraine
Kingsway Hospital
Derby, DE22 3LZ, United Kingdom
Synexus
Greater Manchester, M15 6SX, United Kingdom
Garden Valleys Resource Centre
Harrogate, HG1 2PW, United Kingdom
Kings College Hospital NHS Trust
London, SE5 8EF, United Kingdom
Cornwall Partnership Foundation Trust
Redruth, TR15 2SP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2020
First Posted
August 14, 2020
Study Start
September 15, 2020
Primary Completion
October 3, 2023
Study Completion
October 3, 2023
Last Updated
August 13, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
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