Clinical trial • Phase III • Psychiatry

SELTOREXANT for Major depressive disorder | Insomnia

Phase III trial of SELTOREXANT for Major depressive disorder | Insomnia.

Overview

Trial Therapeutic Area
Psychiatry
Trial Disease
Major depressive disorder | Insomnia
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
29-10-2024
First CTIS Authorization Date
03-03-2025

Trial design

Randomised, open-label, placebo film-coated tablet (matching placebo) versus jnj-42847922 (seltorexant) 20 mg (as adjunctive therapy to an ssri/snri). dose stated as 20 mg for seltorexant; comparator is placebo film-coated tablet. detailed schedule/frequency not specified in the ctis record.-controlled Phase III trial across 75 sites in Slovakia, Bulgaria, Spain and others.

Randomised
Yes
Open Label
Yes
Comparator
Placebo Film-coated tablet (matching placebo) versus JNJ-42847922 (seltorexant) 20 mg (as adjunctive therapy to an SSRI/SNRI). Dose stated as 20 mg for seltorexant; comparator is placebo film-coated tablet. Detailed schedule/frequency not specified in the CTIS record.
Target Sample Size
522
Trial Duration For Participant
126

Eligibility

Recruits 522 Vulnerable population flag selected. Trial population is adults (aged 18–74) including elderly. Subject information sheets and informed consent forms (SIS and ICF) are provided (country-specific versions available) for obtaining informed consent from participants; no assent procedures for minors are specified in the available CTIS Part II materials..

Vulnerable Population
Vulnerable population flag selected. Trial population is adults (aged 18–74) including elderly. Subject information sheets and informed consent forms (SIS and ICF) are provided (country-specific versions available) for obtaining informed consent from participants; no assent procedures for minors are specified in the available CTIS Part II materials.

Inclusion criteria

  • {"criterion_text":"- Participants in Part 1 and Direct Enrollers to Part 2: Participants aged 18 to 74 years (inclusive).\n- Participants must be medically stable based on the following performed at screening: physical examination, vital signs, and 12-lead ECG performed at screening and baseline\n- Meet DSM-5 diagnostic criteria for MDD, without psychotic features.\n- Have had an inadequate response to at least 1 but no more than 2 antidepressants, administered at an adequate dose and duration started in the current episode of depression. An adequate trial is defined as an antidepressant treatment for at least 6 weeks on a stable dose at or above the minimum therapeutic dose specified in the MGH-ATRQ\n- Is receiving and tolerating well any one of the following SSRI or SNRI for depressive symptoms at screening, in any formulation and approved 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\n- Having a major depressive episode of at least moderate severity, as assessed with SIGH-D in a blinded manner at screening and must not demonstrate a clinically significant improvement from the beginning to end of screening\n- Body mass index (BMI) between 18 and 40 kg/m2.\n- Participants Entering After Completing Part 1 (ie, Rollover Participants) must meet the following criteria: Must have completed Part 1 DB treatment phase\n- Can consistently tolerate study drug"}

Exclusion criteria

  • {"criterion_text":"- Participants in Part 1 and Part 2 Direct Enrollers: Has a current or recent history of homicidal ideation or clinically significant suicidal ideation within the past 3 months, or a history of suicidal behavior within the past 6 months.\n- Has a history of treatment-resistant MDD, defined as a lack of response to 2 or more adequate antidepressant treatments in the current episode\n- Current active DSM-5 diagnosis of obsessive-compulsive disorder, posttraumatic stress disorder, anorexia nervosa, bulimia nervosa or fibromyalgia. All of these disorders need to be in remission for at least 1 year for the participant to be enrolled.\n- Has history or current diagnosis of a psychotic disorder, bipolar disorder, intellectual disability, autism spectrum disorder, borderline personality disorder, or somatoform disorders.\n- Has any significant sleep disorder, including but not limited to untreated/uncontrolled obstructive sleep apnea, restless leg syndrome, or parasomnias. Participants with insomnia disorder or well controlled obstructive sleep apnea are allowed\n- Has a history of moderate to severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Part 1 (Efficacy): Change from baseline to Day 43 in the MADRS total score.","definition_or_measurement_approach":"Change from baseline to Day 43 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score; measured by blinded MADRS assessments at baseline and Day 43."}
  • {"endpoint_text":"- Part 2 Time from randomization to the first relapse during the double-blind (DB) Maintenance Phase in participants who achieve a stable response at the end of open-label (OL) seltorexant treatment","definition_or_measurement_approach":"Time-to-event endpoint: time (days) from randomization to first relapse during the double-blind maintenance phase in participants who achieved a stable response after open-label seltorexant; analyzed as time from randomization to relapse."}

Recruitment

Digital Remote Recruitment
True, recruitment uses digital/remote methods including Link2Trials online platform, social media content, banner/online ads, websites, call center scripts and email outreach (country-specific digital materials provided).
Planned Sample Size
522
Recruitment Window Months
21
Consent Approach
Informed consent is obtained from adult participants via Subject Information Sheet (SIS) and Informed Consent Form (ICF) documents. Country-specific ICF/SIS documents are provided (multiple languages/country versions listed, e.g., English, Spanish, Bulgarian, Polish, Czech, Italian, Portuguese, Slovak, Swedish). Consent is provided by the participant (no assent from minors is specified). Additional ICF materials for pregnancy/pregnant partners and privacy appendices are included in the document set.

Methods

  • Link2Trials / vendor-mediated online recruitment (country-specific Link2Trials materials and call center indicated for multiple countries, e.g., IT, SE, CZ, PT) — online platform targeting potential participants in participating countries.
  • Social media content and online advertising (banner ads, online ads) — country-specific social media and banner ad materials listed (e.g., ES, PL, PT, SE, CZ).
  • Website-based recruitment (Link2Trials and local websites) — patient-facing websites and online one-pagers described in recruitment materials.
  • Call centre outreach (Link2Trials call center scripts) — vendor call center scripts and procedures for contacting interested participants.
  • Printed materials and local outreach: flyers, posters, brochures, patient leaflets and posters (country-specific patient flyer and poster materials for Part 1 and Part 2).
  • Physician-to-patient communications / email to patients (country-specific templates) — recruitment material includes 'Email doctor to patient' in some countries.
  • Local clinic/center recruitment through participating hospitals and psychiatric clinics (site-based recruitment using local patient-facing materials).

Geography

Total Number Of Sites
75
Total Number Of Participants
230

Slovakia

Earliest CTIS Part Ii Submission Date
28-02-2025
Latest Decision Or Authorization Date
10-11-2025
Processing Time Days
255
Number Of Sites
6
Number Of Participants
14

Sites

Site Name
Univerzitna nemocnica L. Pasteura Kosice
Department Name
Psychiatricke oddelenie
Contact Person Name
Slavka Dubinska
Contact Person Email
slavka.dubinska@unlp.sk
Site Name
Mentum s.r.o.
Department Name
Psychiatricka ambulancia
Contact Person Name
Peter Molcan
Contact Person Email
molcan@mentum.sk
Site Name
Centrum Zdravia R.B.K. s.r.o.
Department Name
Psychiatricka ambulancia
Contact Person Name
Rastislav Korba
Contact Person Email
rastislav.korba@gmail.com
Site Name
Crystal Comfort s.r.o.
Department Name
Psychiatricka ambulancia
Contact Person Name
Dagmar Breznoscakova
Contact Person Email
dbreznoscakova@gmail.com
Site Name
PsychoLine s.r.o.
Department Name
Psychiatricka ambulancia
Contact Person Name
Abdul Shinwari
Contact Person Email
psycholinesro@gmail.com
Site Name
Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu Liptovsky Mikulas
Department Name
Psychiatricke oddelenie
Contact Person Name
Zuzana Janikova
Contact Person Email
janikova@nsplm.sk

Bulgaria

Earliest CTIS Part Ii Submission Date
10-02-2025
Latest Decision Or Authorization Date
17-10-2025
Processing Time Days
249
Number Of Sites
7
Number Of Participants
24

Sites

Site Name
Center For Mental Health Prof. N. Shipkovenski EOOD
Department Name
Admission-Diagnostic Unit and Day Care Unit
Contact Person Name
Ana Popova
Contact Person Email
dr.anapopova@gmail.com
Site Name
Medical Center Saint Naum EOOD
Contact Person Name
Assen Karadaliev
Contact Person Email
karadaliev@hotmail.com
Site Name
Center For Mental Health Prof. Dr. Ivan Temkov Burgas EOOD
Department Name
Department for Treatment of Emergency Psychiatric Conditions
Contact Person Name
Veselin Palazov
Contact Person Email
vpalazov@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
Psychiatry Clinic
Contact Person Name
Andriana Kakanakova
Site Name
Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD
Contact Person Name
Petya Dimitrova
Contact Person Email
drdimitrova@abv.bg
Site Name
Diagnostics-Consultancy Center Mladost M Varna OOD
Contact Person Name
Hristo Kozhuharov
Contact Person Email
christokojuharov@abv.bg
Site Name
Medical Center Zara-Med EOOD
Contact Person Name
Detelina Komsiyska
Contact Person Email
detelinakomsiiska@abv.bg

Spain

Earliest CTIS Part Ii Submission Date
11-02-2025
Latest Decision Or Authorization Date
15-10-2025
Processing Time Days
246
Number Of Sites
10
Number Of Participants
22

Sites

Site Name
Hospital Universitario Central De Asturias
Department Name
Servicio de Psiquiatria
Contact Person Name
Pilar Saiz
Contact Person Email
Frank@uniovi.es
Site Name
Hestia Palau S.L.
Department Name
Psychiatry
Contact Person Name
Elena Ros
Contact Person Email
e.ros@bcnneuroscience.com
Site Name
Hospital Universitario Basurto
Department Name
Psychiatry
Contact Person Name
Ana Catalán
Contact Person Email
ana.catalanalcantara@gmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Psychiatry
Contact Person Name
Ángela Ibáñez
Contact Person Email
aibanez.hrc@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Psychiatry
Contact Person Name
Eduard Vieta
Contact Person Email
evieta@clinic.cat
Site Name
Hospital Universitario De Torrevieja
Department Name
Psychiatry
Contact Person Name
Jesús Enrique Mesones
Contact Person Email
mesones_jes@gva.es
Site Name
Hospital Universitario La Paz
Department Name
Servicio de Psiquiatria
Contact Person Name
Rosa Villanueva
Site Name
Hospital Universitari Vall D Hebron
Department Name
Psychiatry
Contact Person Name
Amanda Rodríguez
Site Name
Hospital Universitario General De Villalba
Department Name
Psychiatry
Contact Person Name
Enrique Baca
Contact Person Email
EBaca@quironsalud.es
Site Name
Hospital Universitario Infanta Leonor
Department Name
Psychiatry
Contact Person Name
Francisco Javier Quintero
Contact Person Email
fjquinterog@yahoo.es

Romania

Earliest CTIS Part Ii Submission Date
19-11-2024
Latest Decision Or Authorization Date
20-10-2025
Processing Time Days
335
Number Of Sites
12
Number Of Participants
37

Sites

Site Name
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Department Name
Sectia Clinica II
Contact Person Name
Valentin Petre Matei
Contact Person Email
valipmatei@yahoo.com
Site Name
Spitalul Clinic Judetean De Urgenta Bihor
Department Name
Psihiatrie I
Contact Person Name
Adrian Bumbu
Contact Person Email
dradibumbu@gmail.com
Site Name
Spitalul Clinic De Psihiatrie Dr. Gheorghe Preda Sibiu
Department Name
Centrul de Sanatate Mintala Adulti
Contact Person Name
Ana-Ioana Secelean
Site Name
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Department Name
Sectia Clinica IX Psihiatrie
Contact Person Name
Adela Magdalena Ciobanu
Contact Person Email
adela.ciobanu@gmail.com
Site Name
Spitalul Clinic De Psihiatrie Dr. Gheorghe Preda Sibiu
Department Name
Sectia III
Contact Person Name
Ciprian Bacila
Contact Person Email
bacila_c@yahoo.com
Site Name
Institutul De Psihiatrie Socola Iasi
Department Name
Sectia II
Contact Person Name
Raluca-Ioana Modoranu
Contact Person Email
raluca.prepelita@yahoo.com
Site Name
Spitalul Clinic De Psihiatrie Si Neurologie Brasov
Department Name
Psihiatrie
Contact Person Name
Petru-Iulian Ifteni
Contact Person Email
petru_ifteni@yahoo.com
Site Name
Institutul De Psihiatrie Socola Iasi
Department Name
Sectia V
Contact Person Name
Cristinel Stefanescu
Contact Person Email
cristinel.stefanescu@gmail.com
Site Name
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Department Name
Sectia XIV
Contact Person Name
Paul-Sorinel Pletea
Contact Person Email
dr.sorinpletea@gmail.com
Site Name
Institutul De Psihiatrie Socola Iasi
Department Name
Sectia Clinica Psihiatrie III Acuti
Contact Person Name
Ovidiu Alexinschi
Contact Person Email
secretariat@socola.eu
Site Name
Institutul Privat de Cercetare Melchisedec pentru Boli Autoimune, Ereditare si Rare
Department Name
Psihiatrie
Contact Person Name
Victor Gheorman
Contact Person Email
gheormanv@gmail.com
Site Name
Spitalul Clinic Judetean De Urgenta Cluj
Department Name
Psihiatrie I
Contact Person Name
Catalina Crisan
Contact Person Email
ccrisan2004@yahoo.com

Czechia

Earliest CTIS Part Ii Submission Date
10-02-2025
Latest Decision Or Authorization Date
26-02-2026
Processing Time Days
381
Number Of Sites
6
Number Of Participants
23

Sites

Site Name
Clintrial s.r.o.
Department Name
Psychiatrická ambulance
Contact Person Name
Zdeněk Šolle
Contact Person Email
zdenek.solle@clintrial.cz
Site Name
Neuropsychiatrie Petrska s.r.o.
Department Name
Psychiatrická ambulance
Contact Person Name
Aleš Urban
Contact Person Email
ordinace@psychiatrie-urban.cz
Site Name
A-Shine s.r.o.
Department Name
Psychiatrická ambulance
Contact Person Name
Luboš Janů
Contact Person Email
lubos.janu@seznam.cz
Site Name
Pragtis s.r.o.
Department Name
psychiatrická ambulance
Contact Person Name
Martin Anders
Contact Person Email
martin.anders@pragtis.cz
Site Name
Medical Services Prague s.r.o.
Department Name
Psychiatrická ambulance
Contact Person Name
Erik Herman
Contact Person Email
erik.herman@seznam.cz
Site Name
Medipa s.r.o.
Department Name
Psychiatrická ambulance
Contact Person Name
Marta Lendlová
Contact Person Email
lendlova.m@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
03-02-2025
Latest Decision Or Authorization Date
17-10-2025
Processing Time Days
256
Number Of Sites
11
Number Of Participants
42

Sites

Site Name
Specjalistyczna Praktyka Lekarska Piotr Zalitacz
Department Name
Psychiatry
Contact Person Name
Piotr Zalitacz
Contact Person Email
pzalitacz@gmail.com
Site Name
Centrum Zdrowia Alcea
Department Name
Psychiatry
Contact Person Name
Jakub Grabowski
Contact Person Email
jakub.grabowski@gumed.edu.pl
Site Name
Clinic BBP Bozena Pawelczyk
Department Name
Psychiatry
Contact Person Name
Bozena Pawelczyk
Contact Person Email
bozena.pawelczyk@clinicbbp.com
Site Name
Przychodnie Grudziadz Sp. z o.o.
Department Name
Psychiatry
Contact Person Name
Barbara Janczewska
Contact Person Email
basiajanczewska@tlen.pl
Site Name
Praktyka Lekarska dr n med Malgorzata Wojtanowska Bogacka
Department Name
Psychiatry
Contact Person Name
Sylwia Szymkowiak
Contact Person Email
szymkowiaksylwia@gmail.com
Site Name
Ośrodek Badań Klinicznych CLINSANTE S.C.
Contact Person Name
Agnieszka Bijakowska
Contact Person Email
bijak2@wp.pl
Site Name
Mtz Clinical Research Powered By Pratia
Department Name
Psychiatry
Contact Person Name
Bozena Cichosz
Contact Person Email
bcichosz@esculap.pl
Site Name
Centrum Medyczne Intercor Sp. z o.o.
Department Name
Psychiatry
Contact Person Name
Daria Kosinska-Kwasna
Site Name
Samodzielny Wojewodzki Zespol Publicznych Zakladow Psychiatrycznej Opieki Zdrowotnej W Warszawie
Department Name
Szpital Nowowiejski Osrodek Badan Klinicznych
Contact Person Name
Anna Zofia Antosik-Wojcinska
Contact Person Email
antosikwojcinska@gmail.com
Site Name
Niepubliczny Zaklad Opieki Psychiatrycznej Mentis
Department Name
Psychiatry
Contact Person Name
Mariusz Perucki
Contact Person Email
mariperu@wp.pl
Site Name
Promente Sp. z o.o.
Department Name
Psychiatry
Contact Person Name
Katarzyna Lachut
Contact Person Email
k.lachut@pro-mente.pl

Italy

Earliest CTIS Part Ii Submission Date
24-01-2025
Latest Decision Or Authorization Date
29-10-2025
Processing Time Days
278
Number Of Sites
11
Number Of Participants
23

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC di psichiatria clinica e d'urgenza
Contact Person Name
Marco Di Nicola
Site Name
Azienda Ospedaliero-Universitaria Sant Andre
Department Name
U.O.C. Psichiatria
Contact Person Name
Maurizio Pompili
Contact Person Email
maurizio.pompili@uniroma1.it
Site Name
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti
Department Name
UOC Clinica Psichiatrica Uni. Dip. di Neuroscienze, Imaging e Scienze Cliniche PO SS Annunziata
Contact Person Name
Giovanni Martinotti
Contact Person Email
giovanni.martinotti@gmail.com
Site Name
Azienda Sanitaria Locale Di Salerno
Department Name
PO San Francesco d'Assisi di Oliveto Citra – Dip. di Salute mentale, UOSM 5
Contact Person Name
Antonio Mautone
Contact Person Email
a.mautone@aslsalerno.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
U.O. Psichiatria
Contact Person Name
Antonio Vita
Contact Person Email
antonio.vita@unibs.it
Site Name
Azienda Ospedaliera Universitaria Senese
Department Name
UOC PSICHIATRIA
Contact Person Name
Andrea Fagiolini
Contact Person Email
andreafagiolini@gmail.com
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
UO Clinica Psichiatrica
Contact Person Name
Gianluca Serafini
Contact Person Email
gianluca.serafini@unige.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Dipartimento di Salute Mentale e Dipendenze
Contact Person Name
Giuseppe Carrà
Contact Person Email
giuseppe.carra@unimib.it
Site Name
Azienda Ospedaliera di Padova
Department Name
U.O.C. Psichiatria
Contact Person Name
Giorgio Pigato
Contact Person Email
giorgio.pigato@aopd.veneto.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Unità Operativa di Psichiatria
Contact Person Name
Giulio Perugi
Contact Person Email
giulio.perugi@gmail.com
Site Name
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Department Name
U.O.C. Clinica Psichiatrica
Contact Person Name
Antonino Petralia
Contact Person Email
petralia@unict.it

Portugal

Earliest CTIS Part Ii Submission Date
07-02-2025
Latest Decision Or Authorization Date
15-12-2025
Processing Time Days
311
Number Of Sites
8
Number Of Participants
23

Sites

Site Name
Champalimaud Clinical Centre
Department Name
Neuropsychiatry
Contact Person Name
Albino Maia
Site Name
Unidade Local De Saude Da Regiao De Leiria E.P.E.
Department Name
Psychiatry
Contact Person Name
Sofia Marques
Site Name
Unidade Local De Saude Lisboa Ocidental E.P.E.
Department Name
Psychiatry of adults
Contact Person Name
António Talina
Contact Person Email
atalina@chlo.min-saude.pt
Site Name
Unidade Local De Saude De Loures-Odivelas EPE
Department Name
Psychiatry
Contact Person Name
Miguel Constante
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Psychiatry and Mental Health
Contact Person Name
Paulo Martins
Contact Person Email
martintpaulo@gmail.com
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Psychiatry
Contact Person Name
João Bessa
Contact Person Email
joaobessa@med.uminho.pt
Site Name
Hospital Divino Espirito Santo De Ponta Delgada EPER
Department Name
Psychiatry
Contact Person Name
André Ponte
Contact Person Email
andredbponte@gmail.com
Site Name
Hospital CUF Porto S.A.
Department Name
Neuropsychiatry
Contact Person Name
Susana Almeida
Contact Person Email
s.sousa.almeida@gmail.com

Sweden

Earliest CTIS Part Ii Submission Date
06-02-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
299
Number Of Sites
4
Number Of Participants
22

Sites

Site Name
ProbarE i Stockholm AB
Department Name
ProbarE i Stockholm AB
Contact Person Name
Peter Bosson
Contact Person Email
peter.bosson@probare.se
Site Name
ProbarE i Lund AB
Department Name
ProbarE i Lund AB
Contact Person Name
Anders Luts
Contact Person Email
anders.luts@probare.se
Site Name
CTC Clinical Trial Consultants AB (Uppsala)
Department Name
CTC Uppsala
Contact Person Name
Sonia Jonsson
Contact Person Email
sonia.jonsson@ctc-ab.se
Site Name
CTC Clinical Trial Consultants AB (Moelndal)
Department Name
CTC GoCO Molndal
Contact Person Name
Kaj Stenlof
Contact Person Email
Kaj.stenlof@ctc-ab.se

Sponsor

Primary sponsor

Full Name
Janssen Cilag International
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Contract research organisations

Name
Iqvia Inc.
Responsibilities
Central Vendor
Name
4g Clinical LLC

Third parties

  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Central Vendor","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Massachusetts General Hospital - Clinical Trials Network and Institute","duties_or_roles":"Central Vendor","organisation_type":"Health care"}
  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Central ECG","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
JNJ-42847922
Active Substance
SELTOREXANT
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Investigational medicinal product (used in clinical trial)
Starting Dose
20 mg
Dose Levels
20 mg
Investigational Product Name
Placebo Film-coated tablet
Modality
Other
Authorisation Status
Placebo comparator (not an active medicinal product)
Combination Treatment
Yes

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