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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

Primary Purpose

Depressive Disorder, Major

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Seltorexant
Matching placebo to Seltorexant
Quetiapine XR
Matching placebo to Quetiapine XR
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • SW Biomedical Research, LLCRecruiting
  • Proscience Research GroupRecruiting
  • Pharmacology Research Institute
  • Collaborative NeuroScience Network
  • Collaborative NeuroScience Network
  • Pharmacology Research Institute
  • CalNeuro Research
  • Pharmacology Research Institute
  • NRC Research InstituteRecruiting
  • Pacific Neuropsychiatric SpecialistsRecruiting
  • CNRI-Los Angeles, LLCRecruiting
  • Prospective Research Innovations, Inc.Recruiting
  • Anderson Clinical Research
  • University of California at San DiegoRecruiting
  • National Research InstituteRecruiting
  • CI Trials
  • CMB Clinical TrialsRecruiting
  • Schuster Medical Research Institute
  • Pacific Clinical Research Medical GroupRecruiting
  • Hartford Hospital
  • Moonshine Research Center, Inc
  • Velocity Clinical Research, Hallandale BeachRecruiting
  • Indago Research & Health Center IncRecruiting
  • New Life Medical Research Center, Inc.Recruiting
  • Amedica Research Institute, Inc.
  • Meridien Research
  • Premier Clinical ResearchRecruiting
  • Global Medical InstitutesRecruiting
  • Miami Jewish Health System
  • Clinical Neuroscience SolutionsRecruiting
  • Synexus Research Orlando
  • University of South FloridaRecruiting
  • Compass Research LLC-Bioclinica Research
  • Synexus Clinical Research US, IncRecruiting
  • Atlanta Center for Medical ResearchRecruiting
  • iResearch Atlanta LLCRecruiting
  • Psych Atlanta, P.C.
  • Chicago Research Center
  • Capstone Clinical Research
  • Alexian Brothers Health SystemRecruiting
  • Baber Research GroupRecruiting
  • Lemah Creek Clinical ResearchRecruiting
  • Ascension via Christi ResearchRecruiting
  • Riverstar Research
  • Pharmasite Research, Inc.Recruiting
  • BTC of New BedfordRecruiting
  • Boston Clinical Trials & Medical ResearchRecruiting
  • Psychiatric Care and Research Center (PCRC)Recruiting
  • Bio Behavioral HealthRecruiting
  • SPRI Clinical Trials, LLCRecruiting
  • Fieve Clinical Research, Inc.Recruiting
  • The Medical Research Network, LLC
  • Finger Lakes Clinical ResearchRecruiting
  • Richmond Behavioral AssociatesRecruiting
  • Velocity Clinical Research, Inc.
  • University of Cincinnati, Dept of Psychiatry & Behavioral NeuroscienceRecruiting
  • Midwest Clinical Research Center
  • Neuro-Behavioral Clinical ResearchRecruiting
  • Sooner Clinical ResearchRecruiting
  • Paradigm Research Professionals, LLC
  • Suburban Research AssociatesRecruiting
  • Global Medical Institutes
  • Coastal Carolina Research Center
  • West Houston Clinical Research ServiceRecruiting
  • North Texas Clinical TrialsRecruiting
  • Hawkins Psychiatry, PCRecruiting
  • Family Psychiatry of The WoodlandsRecruiting
  • Grayline Research CenterRecruiting
  • Alpine Research OrganizationRecruiting
  • Cedar Clinical ResearchRecruiting
  • University of VirginiaRecruiting
  • Northwest Clinical Research CenterRecruiting
  • Core Clinical ResearchRecruiting
  • Cary J. Kohlenberg, MD, SC, dba, IPC Research.
  • CENydET - Centro Neurobiologico y de Stress Traumatico
  • Hospital FleniRecruiting
  • Hospital ItalianoRecruiting
  • FunDaMosRecruiting
  • Fundacion LennoxRecruiting
  • Instituto Privado Kremer
  • Centro Medico LuquezRecruiting
  • CENPIARecruiting
  • Clinica Privada de Salud Mental Santa Teresa de ÁvilaRecruiting
  • CENAINRecruiting
  • Clinica Mayo de UMCBRecruiting
  • AZ Sint-LucasRecruiting
  • AZ NikolaasRecruiting
  • Medical Center Medconsult-PlevenRecruiting
  • MC 'Hipokrat - N', EOODRecruiting
  • Mental Health Center - RousseRecruiting
  • Medical Center St. NaumRecruiting
  • Medical Center Intermedica, OODRecruiting
  • MC 'Synexus Sofia' EOOD
  • MC 'Synexus Sofia' EOOD
  • UMHAT Prof. Dr. St. Kirkovich ADRecruiting
  • State Psychiatric Hospital - Tzarev Brod
  • Diagnostic Consulting Center Mladost - M VarnaRecruiting
  • Mental Health Center - Veliko Tarnovo EOODRecruiting
  • A.K. Munshi Medical Inc.
  • Canadian Phase Onward
  • Clinique Force Medic (GCP Trials)
  • Psychiatricka ambulance Saint Anne s.r.o.Recruiting
  • NeuropsychiatrieHK, s.r.o.
  • A-Shine s.r.o.
  • Clintrial s.r.o.
  • AD71 s.r.o.Recruiting
  • NeuropsychiatrieHK, s.r.o.Recruiting
  • Institut Neuropsychiatricke peceRecruiting
  • The Mental Hospital of Jelgava Ģintermuiža - PsychiatryRecruiting
  • L. Keruze Practice in PsychiatryRecruiting
  • Hospital of RezekneRecruiting
  • Riga Centre of Psychiatry and NarcologyRecruiting
  • Kaunas Silainiu Outpatient Clinic, Public Institution
  • Republic Kaunas HospitalRecruiting
  • Romuvos Klinika, JSCRecruiting
  • Hospital of Lithuanian University of Health Sciences Kaunas ClinicsRecruiting
  • Medical Center Puriena JSC
  • Zirmunai Mental Health Center, Public Institution
  • Antakalnis Psychiatric Consultation Centre, Public Institution
  • Vilnius Mental Health CenterRecruiting
  • Hospital Raja Permaisuri BainunRecruiting
  • Hospital PermaiRecruiting
  • Hospital Pulau PinangRecruiting
  • Hospital Tuanku JaafarRecruiting
  • Gabinet Lekarski Psychiatryczny Ireneusz KaczorowskiRecruiting
  • Wlokiennicza MED Specjalistyczna Praktyka Lekarska dr n.med. Tomasz MarkowskiRecruiting
  • Przychodnia Srodmiescie SP. z o.o.Recruiting
  • Centrum Badań Klinicznych PI-House sp. z o.o.Recruiting
  • Specjalistyczna Indywidualna Praktyka LekarskaRecruiting
  • CCBR - Lodz - PL
  • Specjalistyczna Praktyka Lekarska Marek DomanskiRecruiting
  • Synexus Polska Sp. z.o.o. Oddzial w PoznaniuRecruiting
  • Instytut Psychiatrii I NeurologiiRecruiting
  • Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp z o.o.
  • Sverdlov Regional Psychiatric Clinical Hospital
  • Engels psychiatric hospital
  • Kemerovo Regional Clinical Psychiatric Hospital
  • GUZ Lipetsk Regional psychoneurological Hospital #1
  • JSC Scientific Centre of Personalized Medicine
  • FSI Moscow SRI of Psychiatry of Minzdravsocrazvitia
  • Moscow Scientific Research Institute of Psychiatry
  • Clinical Psychiatry Hospital n.a. N.N. Solodovnikov
  • St-Petersburg Bekhterev Psychoneurological Research Institute
  • Klinika StoLet Ltd
  • General Hospital Acibadem Bel MedicRecruiting
  • General Hospital EuromedikRecruiting
  • Institute of Mental Health SerbiaRecruiting
  • University Clinical Center of SerbiaRecruiting
  • University Clinical Hospital Center Dr Dragisa Misovic- DediRecruiting
  • Special Neuropsychiatric Hospital KovinRecruiting
  • University Clinical Center KragujevacRecruiting
  • Clinical Center NisRecruiting
  • Specialized Hospital for Neuropsychiatric Diseases Sveti VraceviRecruiting
  • Psychomed-Svatosavsky, s.r.o.Recruiting
  • Nemocnica s poliklinikou Prievidza so sidlom v BojniciachRecruiting
  • Epamed sroRecruiting
  • Liptovska Nemocnica S Poliklinikou Mudr. Ivana StodoluRecruiting
  • Psychiatricka Ambulancia Psycholine S.R.O.Recruiting
  • FN TrencinRecruiting
  • Pro mente sana s.r.o.
  • Fakultna nemocnica s poliklinikou v Ziline
  • MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association
  • Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'
  • Kyiv Territorial Medical Incorporation 'Psychiatry'
  • Railway Clinical Hospital #1 of Kiev Railway station of DTGO 'South-Western Railway'
  • Medical Center Health and Happy
  • Mnpe 'Regional Clinical Psychiatric Hospital of Kirovohrad Regional Council'
  • Ternopil RCCPH Depts of Psychiatry #2 (m) & Psychiatry #4 (f) Ternopil I.Ya. Gorbachevskyi SMU
  • Zaporizhzhia Regional Clinical Hospital
  • Kingsway HospitalRecruiting
  • Synexus
  • Garden Valleys Resource CentreRecruiting
  • Kings College Hospital NHS TrustRecruiting
  • Cornwall Partnership Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Seltorexant

Quetiapine Extended-Release (XR)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from baseline in Weight up to Week 26
Change from baseline in weight will be reported.
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).
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.
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).
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.
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.
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.
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.
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.

Full Information

First Posted
August 13, 2020
Last Updated
September 12, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04513912
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
September 27, 2023 (Anticipated)
Study Completion Date
October 4, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
720 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Seltorexant
Arm Type
Experimental
Arm Description
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.
Arm Title
Quetiapine Extended-Release (XR)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Seltorexant
Intervention Description
Participants will receive seltorexant over-encapsulated tablet orally.
Intervention Type
Drug
Intervention Name(s)
Matching placebo to Seltorexant
Intervention Description
Participants will receive placebo over-encapsulated tablet matching to seltorexant orally.
Intervention Type
Drug
Intervention Name(s)
Quetiapine XR
Intervention Description
Participants will receive quetiapine XR capsule orally.
Intervention Type
Drug
Intervention Name(s)
Matching placebo to Quetiapine XR
Intervention Description
Participants will receive placebo capsule matching to quetiapine XR orally.
Primary Outcome Measure Information:
Title
Percentage of Participants with Response (>=50 Percent improvement in MADRS total score from baseline) at Week 26
Description
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.
Time Frame
Week 26
Secondary Outcome Measure Information:
Title
Change from baseline in Weight up to Week 26
Description
Change from baseline in weight will be reported.
Time Frame
Baseline to Week 26
Title
Time to Study Drug Discontinuation for Potentially Treatment Related Reasons
Description
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).
Time Frame
Up to Week 26
Title
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Description
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.
Time Frame
Baseline to Week 26
Title
Change from Baseline in MADRS-6 Total Score
Description
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).
Time Frame
Baseline to Week 26
Title
Change from Baseline in the MADRS Without Sleep Item (MADRS-WOSI) Total Score
Description
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.
Time Frame
Baseline to Week 26
Title
Change from Baseline in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score
Description
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.
Time Frame
Baseline to Week 26
Title
Percentage of Participants with Remission (MADRS Total Score less than or equal to (<=) 12) at Week 26
Description
Percentage of participants with remission (MADRS total Score <=12) will be reported.
Time Frame
Week 26
Title
Percentage of Participants with a >=50 Percent Improvement in MADRS Total Score and MADRS <=18 at Week 26
Description
Percentage of participants with a >=50 percent improvement in MADRS total score and MADRS <=18 at Week 26.
Time Frame
Week 26
Title
Percentage of Participants with Weight Increase >=7 Percent from Baseline at Week 26
Description
Percentage of participants with weight increase >=7 percent from baseline will be reported.
Time Frame
Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Name
SW Biomedical Research, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Individual Site Status
Recruiting
Facility Name
Proscience Research Group
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Individual Site Status
Recruiting
Facility Name
Pharmacology Research Institute
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Individual Site Status
Completed
Facility Name
Collaborative NeuroScience Network
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Individual Site Status
Completed
Facility Name
Collaborative NeuroScience Network
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Completed
Facility Name
Pharmacology Research Institute
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Individual Site Status
Completed
Facility Name
CalNeuro Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Completed
Facility Name
Pharmacology Research Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Individual Site Status
Completed
Facility Name
NRC Research Institute
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
Pacific Neuropsychiatric Specialists
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
CNRI-Los Angeles, LLC
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Individual Site Status
Recruiting
Facility Name
Prospective Research Innovations, Inc.
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Individual Site Status
Recruiting
Facility Name
Anderson Clinical Research
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Individual Site Status
Completed
Facility Name
University of California at San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Name
National Research Institute
City
Santa Ana
State/Province
California
ZIP/Postal Code
91704
Country
United States
Individual Site Status
Recruiting
Facility Name
CI Trials
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Individual Site Status
Completed
Facility Name
CMB Clinical Trials
City
Santee
State/Province
California
ZIP/Postal Code
92071
Country
United States
Individual Site Status
Recruiting
Facility Name
Schuster Medical Research Institute
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Individual Site Status
Completed
Facility Name
Pacific Clinical Research Medical Group
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Individual Site Status
Recruiting
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Individual Site Status
Completed
Facility Name
Moonshine Research Center, Inc
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Individual Site Status
Completed
Facility Name
Velocity Clinical Research, Hallandale Beach
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Individual Site Status
Recruiting
Facility Name
Indago Research & Health Center Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Recruiting
Facility Name
New Life Medical Research Center, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Recruiting
Facility Name
Amedica Research Institute, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Individual Site Status
Completed
Facility Name
Meridien Research
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33803
Country
United States
Individual Site Status
Completed
Facility Name
Premier Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Individual Site Status
Recruiting
Facility Name
Global Medical Institutes
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Recruiting
Facility Name
Miami Jewish Health System
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Individual Site Status
Completed
Facility Name
Clinical Neuroscience Solutions
City
Orlando
State/Province
Florida
ZIP/Postal Code
23801
Country
United States
Individual Site Status
Recruiting
Facility Name
Synexus Research Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Completed
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Compass Research LLC-Bioclinica Research
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Individual Site Status
Completed
Facility Name
Synexus Clinical Research US, Inc
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Recruiting
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Individual Site Status
Recruiting
Facility Name
iResearch Atlanta LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Name
Psych Atlanta, P.C.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Completed
Facility Name
Chicago Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
Individual Site Status
Completed
Facility Name
Capstone Clinical Research
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Individual Site Status
Completed
Facility Name
Alexian Brothers Health System
City
Lisle
State/Province
Illinois
ZIP/Postal Code
60532
Country
United States
Individual Site Status
Recruiting
Facility Name
Baber Research Group
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Individual Site Status
Recruiting
Facility Name
Lemah Creek Clinical Research
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60618
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascension via Christi Research
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Individual Site Status
Recruiting
Facility Name
Riverstar Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Individual Site Status
Completed
Facility Name
Pharmasite Research, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Individual Site Status
Recruiting
Facility Name
BTC of New Bedford
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Individual Site Status
Recruiting
Facility Name
Boston Clinical Trials & Medical Research
City
Roslindale
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Individual Site Status
Recruiting
Facility Name
Psychiatric Care and Research Center (PCRC)
City
O'Fallon
State/Province
Missouri
ZIP/Postal Code
63368
Country
United States
Individual Site Status
Recruiting
Facility Name
Bio Behavioral Health
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Individual Site Status
Recruiting
Facility Name
SPRI Clinical Trials, LLC
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Individual Site Status
Recruiting
Facility Name
Fieve Clinical Research, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Individual Site Status
Recruiting
Facility Name
The Medical Research Network, LLC
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Individual Site Status
Completed
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618-1609
Country
United States
Individual Site Status
Recruiting
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research, Inc.
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States
Individual Site Status
Completed
Facility Name
University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Individual Site Status
Completed
Facility Name
Neuro-Behavioral Clinical Research
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Individual Site Status
Recruiting
Facility Name
Sooner Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Recruiting
Facility Name
Paradigm Research Professionals, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Individual Site Status
Completed
Facility Name
Suburban Research Associates
City
Pine Hill
State/Province
Pennsylvania
ZIP/Postal Code
08021
Country
United States
Individual Site Status
Recruiting
Facility Name
Global Medical Institutes
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18503
Country
United States
Individual Site Status
Completed
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Individual Site Status
Completed
Facility Name
West Houston Clinical Research Service
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Name
North Texas Clinical Trials
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Name
Hawkins Psychiatry, PC
City
Mansfield
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Individual Site Status
Recruiting
Facility Name
Family Psychiatry of The Woodlands
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
Individual Site Status
Recruiting
Facility Name
Grayline Research Center
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Individual Site Status
Recruiting
Facility Name
Alpine Research Organization
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Individual Site Status
Recruiting
Facility Name
Cedar Clinical Research
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Individual Site Status
Recruiting
Facility Name
Core Clinical Research
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Individual Site Status
Recruiting
Facility Name
Cary J. Kohlenberg, MD, SC, dba, IPC Research.
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Individual Site Status
Completed
Facility Name
CENydET - Centro Neurobiologico y de Stress Traumatico
City
Buenos Aires
ZIP/Postal Code
1058AAJ
Country
Argentina
Individual Site Status
Completed
Facility Name
Hospital Fleni
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1428AQK
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Italiano
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
1199
Country
Argentina
Individual Site Status
Recruiting
Facility Name
FunDaMos
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1405BOA
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Fundacion Lennox
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto Privado Kremer
City
Cordoba
ZIP/Postal Code
X5004AOA
Country
Argentina
Individual Site Status
Completed
Facility Name
Centro Medico Luquez
City
Cordoba
ZIP/Postal Code
X5006IKK
Country
Argentina
Individual Site Status
Recruiting
Facility Name
CENPIA
City
La Plata
ZIP/Postal Code
1902
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Clinica Privada de Salud Mental Santa Teresa de Ávila
City
La Plata
ZIP/Postal Code
Thanks
Country
Argentina
Individual Site Status
Recruiting
Facility Name
CENAIN
City
Mendoza
ZIP/Postal Code
M5502AWY
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Clinica Mayo de UMCB
City
San Miguel de Tucuman
ZIP/Postal Code
4000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
AZ Sint-Lucas
City
Brugge
ZIP/Postal Code
8310
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Nikolaas
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Medical Center Medconsult-Pleven
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
MC 'Hipokrat - N', EOOD
City
Plovdiv
ZIP/Postal Code
4028
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Mental Health Center - Rousse
City
Ruse
ZIP/Postal Code
7003
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center St. Naum
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Intermedica, OOD
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
MC 'Synexus Sofia' EOOD
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Individual Site Status
Completed
Facility Name
MC 'Synexus Sofia' EOOD
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Individual Site Status
Completed
Facility Name
UMHAT Prof. Dr. St. Kirkovich AD
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
State Psychiatric Hospital - Tzarev Brod
City
Tzarev Brod
ZIP/Postal Code
9747
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Diagnostic Consulting Center Mladost - M Varna
City
Varna
ZIP/Postal Code
9020
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Mental Health Center - Veliko Tarnovo EOOD
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
A.K. Munshi Medical Inc.
City
Sydney
State/Province
Nova Scotia
ZIP/Postal Code
B1P 1E1
Country
Canada
Individual Site Status
Completed
Facility Name
Canadian Phase Onward
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3J 2C5
Country
Canada
Individual Site Status
Completed
Facility Name
Clinique Force Medic (GCP Trials)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1M 1B1
Country
Canada
Individual Site Status
Completed
Facility Name
Psychiatricka ambulance Saint Anne s.r.o.
City
Brno
ZIP/Postal Code
60200
Country
Czechia
Individual Site Status
Recruiting
Facility Name
NeuropsychiatrieHK, s.r.o.
City
Hradec Kralove
ZIP/Postal Code
500 09
Country
Czechia
Individual Site Status
Completed
Facility Name
A-Shine s.r.o.
City
Plzen
ZIP/Postal Code
301 00
Country
Czechia
Individual Site Status
Completed
Facility Name
Clintrial s.r.o.
City
Praha 10
ZIP/Postal Code
100 00
Country
Czechia
Individual Site Status
Completed
Facility Name
AD71 s.r.o.
City
Praha 10
ZIP/Postal Code
10000
Country
Czechia
Individual Site Status
Recruiting
Facility Name
NeuropsychiatrieHK, s.r.o.
City
Praha 6
ZIP/Postal Code
160 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Institut Neuropsychiatricke pece
City
Praha 8
ZIP/Postal Code
186 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
The Mental Hospital of Jelgava Ģintermuiža - Psychiatry
City
Jelgava
ZIP/Postal Code
LV-3008
Country
Latvia
Individual Site Status
Recruiting
Facility Name
L. Keruze Practice in Psychiatry
City
Liepaja
ZIP/Postal Code
LV-3401
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Hospital of Rezekne
City
Outpatient Centre Of Psychiatry
ZIP/Postal Code
LV-4601
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Riga Centre of Psychiatry and Narcology
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Kaunas Silainiu Outpatient Clinic, Public Institution
City
Kaunas
ZIP/Postal Code
48259
Country
Lithuania
Individual Site Status
Completed
Facility Name
Republic Kaunas Hospital
City
Kaunas
ZIP/Postal Code
53136
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Romuvos Klinika, JSC
City
Kaunas
ZIP/Postal Code
LT-44279
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Medical Center Puriena JSC
City
Silute
ZIP/Postal Code
99176
Country
Lithuania
Individual Site Status
Completed
Facility Name
Zirmunai Mental Health Center, Public Institution
City
Vilnius
ZIP/Postal Code
09112
Country
Lithuania
Individual Site Status
Completed
Facility Name
Antakalnis Psychiatric Consultation Centre, Public Institution
City
Vilnius
ZIP/Postal Code
10204
Country
Lithuania
Individual Site Status
Completed
Facility Name
Vilnius Mental Health Center
City
Vilnius
ZIP/Postal Code
10309
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Hospital Raja Permaisuri Bainun
City
Ipoh
ZIP/Postal Code
30990
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Permai
City
Johor Bahru
ZIP/Postal Code
81200
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Pulau Pinang
City
Pulau Pinang
ZIP/Postal Code
10990
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Tuanku Jaafar
City
Seremban
ZIP/Postal Code
70300
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski
City
Belchatow
ZIP/Postal Code
97-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wlokiennicza MED Specjalistyczna Praktyka Lekarska dr n.med. Tomasz Markowski
City
Bialystok
ZIP/Postal Code
15-464
Country
Poland
Individual Site Status
Recruiting
Facility Name
Przychodnia Srodmiescie SP. z o.o.
City
Bydgoszcz
ZIP/Postal Code
85-080
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Badań Klinicznych PI-House sp. z o.o.
City
Gdansk
ZIP/Postal Code
80-546
Country
Poland
Individual Site Status
Recruiting
Facility Name
Specjalistyczna Indywidualna Praktyka Lekarska
City
Lodz
ZIP/Postal Code
90-009
Country
Poland
Individual Site Status
Recruiting
Facility Name
CCBR - Lodz - PL
City
Lodz
ZIP/Postal Code
90-368
Country
Poland
Individual Site Status
Completed
Facility Name
Specjalistyczna Praktyka Lekarska Marek Domanski
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Individual Site Status
Recruiting
Facility Name
Synexus Polska Sp. z.o.o. Oddzial w Poznaniu
City
Poznan
ZIP/Postal Code
60-702
Country
Poland
Individual Site Status
Recruiting
Facility Name
Instytut Psychiatrii I Neurologii
City
Warsaw
ZIP/Postal Code
02-957
Country
Poland
Individual Site Status
Recruiting
Facility Name
Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp z o.o.
City
Warszawa
ZIP/Postal Code
01-737
Country
Poland
Individual Site Status
Completed
Facility Name
Sverdlov Regional Psychiatric Clinical Hospital
City
Ekaterinburg
ZIP/Postal Code
620030
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Engels psychiatric hospital
City
Engels, Saratov Region
ZIP/Postal Code
413124
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Kemerovo Regional Clinical Psychiatric Hospital
City
Kemerovo
ZIP/Postal Code
650036
Country
Russian Federation
Individual Site Status
Completed
Facility Name
GUZ Lipetsk Regional psychoneurological Hospital #1
City
Lipetsk Region
ZIP/Postal Code
399313
Country
Russian Federation
Individual Site Status
Completed
Facility Name
JSC Scientific Centre of Personalized Medicine
City
Moscow
ZIP/Postal Code
105082
Country
Russian Federation
Individual Site Status
Completed
Facility Name
FSI Moscow SRI of Psychiatry of Minzdravsocrazvitia
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Moscow Scientific Research Institute of Psychiatry
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Clinical Psychiatry Hospital n.a. N.N. Solodovnikov
City
Omsk
ZIP/Postal Code
644070
Country
Russian Federation
Individual Site Status
Completed
Facility Name
St-Petersburg Bekhterev Psychoneurological Research Institute
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Klinika StoLet Ltd
City
Tomsk
ZIP/Postal Code
634009
Country
Russian Federation
Individual Site Status
Completed
Facility Name
General Hospital Acibadem Bel Medic
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
General Hospital Euromedik
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Institute of Mental Health Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
University Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
University Clinical Hospital Center Dr Dragisa Misovic- Dedi
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Special Neuropsychiatric Hospital Kovin
City
Kovin
ZIP/Postal Code
26220
Country
Serbia
Individual Site Status
Recruiting
Facility Name
University Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Clinical Center Nis
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi
City
Novi Knezevac
ZIP/Postal Code
23330
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Psychomed-Svatosavsky, s.r.o.
City
Banska Bystrica
ZIP/Postal Code
97401
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach
City
Bojnice
ZIP/Postal Code
97201
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Epamed sro
City
Koshice
ZIP/Postal Code
040 11
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu
City
Liptovsky Mikulas
ZIP/Postal Code
03123
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Psychiatricka Ambulancia Psycholine S.R.O.
City
Rimavska Sobota
ZIP/Postal Code
97901
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
FN Trencin
City
Trencin
ZIP/Postal Code
91101
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Pro mente sana s.r.o.
City
Trencin
ZIP/Postal Code
91108
Country
Slovakia
Individual Site Status
Completed
Facility Name
Fakultna nemocnica s poliklinikou v Ziline
City
Zilina
ZIP/Postal Code
1207
Country
Slovakia
Individual Site Status
Completed
Facility Name
MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association
City
Glevakha
ZIP/Postal Code
8631
Country
Ukraine
Individual Site Status
Completed
Facility Name
Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Individual Site Status
Completed
Facility Name
Kyiv Territorial Medical Incorporation 'Psychiatry'
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Individual Site Status
Completed
Facility Name
Railway Clinical Hospital #1 of Kiev Railway station of DTGO 'South-Western Railway'
City
Kyiv
ZIP/Postal Code
1030
Country
Ukraine
Individual Site Status
Completed
Facility Name
Medical Center Health and Happy
City
Kyiv
ZIP/Postal Code
1034
Country
Ukraine
Individual Site Status
Completed
Facility Name
Mnpe 'Regional Clinical Psychiatric Hospital of Kirovohrad Regional Council'
City
Nove, Kropyvnytskiy
ZIP/Postal Code
25491
Country
Ukraine
Individual Site Status
Completed
Facility Name
Ternopil RCCPH Depts of Psychiatry #2 (m) & Psychiatry #4 (f) Ternopil I.Ya. Gorbachevskyi SMU
City
Ternopil
ZIP/Postal Code
46020
Country
Ukraine
Individual Site Status
Completed
Facility Name
Zaporizhzhia Regional Clinical Hospital
City
Zaporizhzhia
ZIP/Postal Code
69600
Country
Ukraine
Individual Site Status
Completed
Facility Name
Kingsway Hospital
City
Derby
ZIP/Postal Code
DE22 3LZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Synexus
City
Greater Manchester
ZIP/Postal Code
M15 6SX
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Garden Valleys Resource Centre
City
Harrogate
ZIP/Postal Code
HG1 2PW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Kings College Hospital NHS Trust
City
London
ZIP/Postal Code
SE5 8EF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Cornwall Partnership Foundation Trust
City
Redruth
ZIP/Postal Code
TR15 2SP
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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