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

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04513912
Collaborator
(none)
720
213
2
35.3
3.4
0.1

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Seltorexant
  • Drug: Matching placebo to Seltorexant
  • Drug: Quetiapine XR
  • Drug: Matching placebo to Quetiapine XR
Phase 3

Detailed Description

Major depressive disorder (MDD) is a common, serious, recurrent disorder. Seltorexant (JNJ-42847922) is a potent and selective antagonist of the human orexin-2 receptor (OX2R) that is being developed for the adjunctive treatment of MDDIS. The hypothesis for this study is that seltorexant is superior to quetiapine XR in leading to a response after 26 weeks of treatment (greater than or equal to [>=] 50 percent [%] improvement on baseline Montgomery Asberg Depression Rating Scale [MADRS] total score), when administered as adjunctive treatment to an antidepressant in adult and elderly participants with MDDIS who have had an inadequate response to treatment with an SSRI/SNRI. The study will be conducted in 3 phases: a screening phase (up to 30 days), a double-blind (DB) treatment phase (26 weeks), and a post treatment follow-up phase (7 to 14 days after the end of DB treatment phase for all participants, and up to 196 days from baseline for participants who stop study treatment early). The total study duration for each participant will be approximately 32 weeks. Efficacy, safety, pharmacokinetics, and biomarkers will be assessed at specified time points during this study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
720 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 15, 2020
Anticipated Primary Completion Date :
Dec 26, 2022
Anticipated Study Completion Date :
Aug 25, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Seltorexant

Adult participants will receive seltorexant once daily from Day 1-7 and together with matching placebo from Day 8 till Day 182. Elderly participants will receive seltorexant once daily from Day 1-3 and together with matching placebo from Day 4 till Day 182.

Drug: Seltorexant
Participants will receive seltorexant over-encapsulated tablet orally.

Drug: Matching placebo to Seltorexant
Participants will receive placebo over-encapsulated tablet matching to seltorexant orally.

Active Comparator: Quetiapine Extended-Release (XR)

Adult participants will receive quetiapine XR once daily from Day 1-2, followed by an increase in dose from Day 3-7, and from Day 8-14 together with matching placebo. After Day 14, quetiapine XR twice daily from Day 14 till Day 182. Elderly participants will receive quetiapine XR once daily from Day 1-3 and twice from Day 4-7, followed by an increase in dose once daily from Day 8-14 together with matching placebo. After Day 14 till Day 182, quetiapine XR will be adjusted by investigator based on the participant's clinical response and tolerability.

Drug: Quetiapine XR
Participants will receive quetiapine XR capsule orally.

Drug: Matching placebo to Quetiapine XR
Participants will receive placebo capsule matching to quetiapine XR orally.

Outcome Measures

Primary Outcome Measures

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

  1. Change from baseline in Weight up to Week 26 [Baseline to Week 26]

    Change from baseline in weight will be reported.

  2. Time to Study Drug Discontinuation for Potentially Treatment Related Reasons [Up to Week 26]

    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).

  3. Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [Baseline to Week 26]

    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.

  4. Change from Baseline in MADRS-6 Total Score [Baseline to Week 26]

    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).

  5. Change from Baseline in the MADRS Without Sleep Item (MADRS-WOSI) Total Score [Baseline to Week 26]

    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.

  6. Change from Baseline in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score [Baseline to Week 26]

    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.

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

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

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

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

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 74 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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/m2), inclusive (BMI=weight/height2)

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35233
2 SW Biomedical Research, LLC Tucson Arizona United States 85712
3 Southern California Research LLC Beverly Hills California United States 90210
4 Proscience Research Group Culver City California United States 90230
5 Pharmacology Research Institute Encino California United States 91316
6 Collaborative NeuroScience Network Garden Grove California United States 92845
7 Collaborative NeuroScience Network Long Beach California United States 90806
8 Pharmacology Research Institute Los Alamitos California United States 90720
9 CalNeuro Research Los Angeles California United States 90024
10 Cedars Sinai Medical Center Los Angeles California United States 90048
11 Pharmacology Research Institute Newport Beach California United States 92660
12 NRC Research Institute Orange California United States 92868
13 Pacific Neuropsychiatric Specialists Orange California United States 92868
14 CNRI-Los Angeles, LLC Pico Rivera California United States 90660
15 Prospective Research Innovations, Inc. Rancho Cucamonga California United States 91730
16 Anderson Clinical Research Redlands California United States 92374
17 University of California at San Diego San Diego California United States 92103
18 University of California San Francisco San Francisco California United States 94143-0984
19 National Research Institute Santa Ana California United States 91704
20 CI Trials Santa Ana California United States 92705
21 CMB Clinical Trials Santee California United States 92071
22 Schuster Medical Research Institute Sherman Oaks California United States 91403
23 Pacific Clinical Research Medical Group Upland California United States 91786
24 Hartford Hospital Hartford Connecticut United States 06102
25 Yale University New Haven Connecticut United States 06516
26 Innovative Research of West Florida, Incorporated Clearwater Florida United States 33756
27 Moonshine Research Center, Inc Doral Florida United States 33166
28 Velocity Clinical Research, Hallandale Beach Hallandale Beach Florida United States 33009
29 Indago Research & Health Center Inc Hialeah Florida United States 33012
30 New Life Medical Research Center, Inc. Hialeah Florida United States 33012
31 Meridien Research Lakeland Florida United States 33803
32 Premier Clinical Research Miami Florida United States 33122
33 Global Medical Institutes Miami Florida United States 33125
34 Miami Jewish Health System Miami Florida United States 33137
35 Clinical Neuroscience Solutions Orlando Florida United States 23801
36 Synexus Research Orlando Orlando Florida United States 32806
37 Meridien Research Saint Petersburg Florida United States 33709
38 University of South Florida Tampa Florida United States 33612
39 Compass Research LLC-Bioclinica Research The Villages Florida United States 32162
40 Synexus Clinical Research US, Inc Atlanta Georgia United States 30328
41 Atlanta Center for Medical Research Atlanta Georgia United States 30331
42 iResearch Atlanta LLC Decatur Georgia United States 30030
43 Psych Atlanta, P.C. Marietta Georgia United States 30060
44 Chicago Research Center Chicago Illinois United States 60634
45 Capstone Clinical Research Libertyville Illinois United States 60048
46 Alexian Brothers Health System Lisle Illinois United States 60532
47 Baber Research Group Naperville Illinois United States 60563
48 Lemah Creek Clinical Research Oakbrook Terrace Illinois United States 60618
49 Heartland Research Associates, an AMR Company Wichita Kansas United States 67207
50 Ascension via Christi Research Wichita Kansas United States 67214
51 Lake Charles Clinical Trials Lake Charles Louisiana United States 70629
52 Riverstar Research New Orleans Louisiana United States 70115
53 Pharmasite Research, Inc. Baltimore Maryland United States 21208
54 BTC of New Bedford New Bedford Massachusetts United States 02740
55 Boston Clinical Trials & Medical Research Roslindale Massachusetts United States 02135
56 Adams Clinical Watertown Massachusetts United States 02472
57 Neurobehavioral Medicine Group Bloomfield Hills Michigan United States 48302
58 Rochester Center for Behavioral Medicine (RCBM) Rochester Hills Michigan United States 48307
59 Psychiatric Care and Research Center (PCRC) O'Fallon Missouri United States 63368
60 Bio Behavioral Health Toms River New Jersey United States 08755
61 SPRI Clinical Trials, LLC Brooklyn New York United States 11235
62 Fieve Clinical Research, Inc. New York New York United States 10017
63 The Medical Research Network, LLC New York New York United States 10128
64 Finger Lakes Clinical Research Rochester New York United States 14618-1609
65 Richmond Behavioral Associates Staten Island New York United States 10312
66 Stony Brook University Medical Center Stony Brook New York United States 11794-0001
67 Velocity Clinical Research, Inc. Durham North Carolina United States 27701
68 University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience Cincinnati Ohio United States 45219
69 Midwest Clinical Research Center Dayton Ohio United States 45417
70 Neuro-Behavioral Clinical Research North Canton Ohio United States 44720
71 Sooner Clinical Research Oklahoma City Oklahoma United States 73112
72 Paradigm Research Professionals, LLC Oklahoma City Oklahoma United States 73118
73 Oregon Center for Clinical Investigations, Inc. Portland Oregon United States 97214
74 Suburban Research Associates Pine Hill Pennsylvania United States 08021
75 Global Medical Institutes Scranton Pennsylvania United States 18503
76 Coastal Carolina Research Center Mount Pleasant South Carolina United States 29464
77 Spartanburg Medical Research Spartanburg South Carolina United States 29303
78 Clinical NeuroScience Solutions, Inc Memphis Tennessee United States 38119
79 West Houston Clinical Research Service Bellaire Texas United States 77401
80 Future Search Trials of Dallas Dallas Texas United States 75231
81 North Texas Clinical Trials Fort Worth Texas United States 76104
82 Hawkins Psychiatry, PC Mansfield Texas United States 76054
83 Clinical Trials of Texas, Inc San Antonio Texas United States 78229
84 Family Psychiatry of The Woodlands The Woodlands Texas United States 77381
85 Grayline Research Center Wichita Falls Texas United States 76309
86 Alpine Research Organization Clinton Utah United States 84015
87 Cedar Clinical Research Draper Utah United States 84020
88 University of Virginia Charlottesville Virginia United States 22903
89 Northwest Clinical Research Center Bellevue Washington United States 98007
90 Core Clinical Research Everett Washington United States 98201
91 Cary J. Kohlenberg, MD, SC, dba, IPC Research. Waukesha Wisconsin United States 53188
92 CENydET - Centro Neurobiologico y de Stress Traumatico Buenos Aires Argentina 1058AAJ
93 Hospital Fleni Ciudad Autonoma Buenos Aires Argentina C1428AQK
94 Hospital Italiano Ciudad Autonoma de Buenos Aires Argentina 1199
95 FunDaMos Ciudad Autonoma de Buenos Aires Argentina C1405BOA
96 Fundacion Lennox Cordoba Argentina 5000
97 Instituto Privado Kremer Cordoba Argentina X5004AOA
98 Centro Medico Luquez Cordoba Argentina X5006IKK
99 CENPIA La Plata Argentina 1902
100 Clinica Privada de Salud Mental Santa Teresa de Ávila La Plata Argentina Thanks
101 CENAIN Mendoza Argentina M5502AWY
102 Clinica Mayo de UMCB San Miguel de Tucuman Argentina 4000
103 Clinica El Jardin Santiago del Estero Argentina 4200
104 Medizinische Universität Innsbruck Innsbruck Austria 6020
105 AZ Sint-Lucas Brugge Belgium 8310
106 Clinique Psychiatrique des Frères Alexiens Henri-Chapelle Belgium 4841
107 CHU de Liège Liège Belgium 4000
108 AZ Nikolaas Sint-Niklaas Belgium 9100
109 CHU UCL Namur - Site Godinne Yvoir Belgium 5530
110 Medical Center Medconsult-Pleven Pleven Bulgaria 5800
111 MC 'Hipokrat - N', EOOD Plovdiv Bulgaria 4028
112 Mental Health Center - Rousse Ruse Bulgaria 7003
113 Medical Center Intermedica, OOD Sofia Bulgaria 1680
114 MC 'Synexus Sofia' EOOD Sofia Bulgaria 1784
115 MC 'Synexus Sofia' EOOD Stara Zagora Bulgaria 6000
116 UMHAT Prof. Dr. St. Kirkovich AD Stara Zagora Bulgaria 6003
117 State Psychiatric Hospital - Tzarev Brod Tzarev Brod Bulgaria 9747
118 Diagnostic Consulting Center Mladost - M Varna Varna Bulgaria 9020
119 Mental Health Center - Veliko Tarnovo EOOD Veliko Tarnovo Bulgaria 5000
120 A.K. Munshi Medical Inc. Sydney Nova Scotia Canada B1P 1E1
121 Recherches Neuro-Hippocampe Inc. Ottawa Ontario Canada K1Z 1G3
122 Canadian Phase Onward Toronto Ontario Canada M3J 2C5
123 Clinique Force Medic (GCP Trials) Montreal Quebec Canada H1M 1B1
124 DIEX Recherche Sherbrooke Inc. Sherbrooke Quebec Canada J1L 0H8
125 Psychiatricka ambulance Saint Anne s.r.o. Brno Czechia 60200
126 NeuropsychiatrieHK, s.r.o. Hradec Kralove Czechia 500 09
127 AD71 s.r.o. Praha 10 Czechia 10000
128 NeuropsychiatrieHK, s.r.o. Praha 6 Czechia 160 00
129 Institut Neuropsychiatricke pece Praha 8 Czechia 186 00
130 Marienthali Kliinik Tallinn Estonia 11315
131 Tartu University Hospital Tartu Estonia 50406
132 The Mental Hospital of Jelgava Ģintermuiža - Psychiatry Jelgava Latvia LV-3008
133 L. Keruze Practice in Psychiatry Liepaja Latvia LV-3401
134 Hospital of Rezekne Outpatient Centre Of Psychiatry Latvia LV-4601
135 Riga Centre of Psychiatry and Narcology Riga Latvia LV-1002
136 Kaunas Silainiu Outpatient Clinic, Public Institution Kaunas Lithuania 48259
137 Neuromeda, JSC Kaunas Lithuania 50185
138 Republic Kaunas Hospital Kaunas Lithuania 53136
139 Romuvos Klinika, JSC Kaunas Lithuania LT-44279
140 Hospital of Lithuanian University of Health Sciences Kaunas Clinics Kaunas Lithuania LT-50009
141 Silutes Mental health and psychotherapy center, JSC Silute Lithuania 99142
142 Zirmunai Mental Health Center, Public Institution Vilnius Lithuania 09112
143 Antakalnis Psychiatric Consultation Centre, Public Institution Vilnius Lithuania 10204
144 Vilnius Mental Health Center Vilnius Lithuania 10309
145 Hospital Raja Permaisuri Bainun Ipoh Malaysia 30990
146 Hospital Permai Johor Bahru Malaysia 81200
147 Hospital Pulau Pinang Pulau Pinang Malaysia 10990
148 Hospital Tuanku Jaafar Seremban Malaysia 70300
149 Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski Belchatow Poland 97-400
150 Wlokiennicza MED Specjalistyczna Praktyka Lekarska dr n.med. Tomasz Markowski Bialystok Poland 15-464
151 Przychodnia Srodmiescie SP. z o.o. Bydgoszcz Poland 85-080
152 Osrodek Badan Klinicznych CLINSANTE S.C. Bydgoszcz Poland 85-794
153 Centrum Badań Klinicznych PI-House sp. z o.o. Gdansk Poland 80-546
154 SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im. Prof. Leszka Gieca Katowice Poland 40-635
155 Specjalistyczna Indywidualna Praktyka Lekarska Lodz Poland 90-009
156 CCBR - Lodz - PL Lodz Poland 90-368
157 Specjalistyczna Praktyka Lekarska Marek Domanski Lublin Poland 20-582
158 Synexus Polska Sp. z.o.o. Oddzial w Poznaniu Poznan Poland 60-702
159 Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp z o.o. Warszawa Poland 01-737
160 Instytut Psychiatrii I Neurologii Warszawa Poland 02-957
161 Sverdlov Regional Psychiatric Clinical Hospital Ekaterinburg Russian Federation 620030
162 Engels psychiatric hospital Engels, Saratov Region Russian Federation 413124
163 Kemerovo Regional Clinical Psychiatric Hospital Kemerovo Russian Federation 650036
164 GUZ Lipetsk Regional psychoneurological Hospital #1 Lipetsk Region Russian Federation 399313
165 JSC Scientific Centre of Personalized Medicine Moscow Russian Federation 105082
166 FSI Moscow SRI of Psychiatry of Minzdravsocrazvitia Moscow Russian Federation 107076
167 Moscow Scientific Research Institute of Psychiatry Moscow Russian Federation 107076
168 Federal State Budgetary Scientific Instit Moscow Russian Federation 115522
169 FSAEI HE &quot;Russian University of Peoples&#39; Friendship&quot; Moscow Russian Federation 117198
170 Clinical Psychiatry Hospital n.a. N.N. Solodovnikov Omsk Russian Federation 644070
171 State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary Roshchino Russian Federation 188820
172 Dermatovenerological Dispensary #10 Saint-Petersburg Russian Federation 190121
173 St Petersburg State Institution &quot;Psychoneurological Dispensary #5 Saint-Petersburg Russian Federation 195160
174 St-Petersburg Bekhterev Psychoneurological Research Institute St. Petersburg Russian Federation 192019
175 Klinika StoLet Ltd Tomsk Russian Federation 634009
176 Bel Medic General Hospital Belgrade Serbia 11000
177 General Hospital Euromedik Belgrade Serbia 11000
178 Institute of Mental Health Serbia Belgrade Serbia 11000
179 University Clinical Center of Serbia Belgrade Serbia 11000
180 University Clinical Hospital Center Dr Dragisa Misovic- Dedi Belgrade Serbia 11000
181 Special Psychiatric Hospital Gornja Toponica Serbia 18202
182 Special Neuropsychiatric Hospital Kovin Kovin Serbia 26220
183 University Clinical Center Kragujevac Kragujevac Serbia 34000
184 Clinical Center Nis Nis Serbia 18000
185 Specialized Hospital for Neuropsychiatric Diseases 'Sveti Vracevi' Novi Knezevac Serbia 23330
186 Special Hospital for Psychiatric Disease Dr Slavoljub Bakalovic Vrsac Serbia 26300
187 Psychomed-Svatosavsky, s.r.o. Banska Bystrica Slovakia 97401
188 Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach Bojnice Slovakia 97201
189 Epamed sro Koshice Slovakia 040 11
190 Univerzitna nemocnica L. Pasteura Kosice Kosice Slovakia 04190
191 Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu Liptovsky Mikulas Slovakia 03123
192 Psychiatricka Ambulancia Psycholine S.R.O. Rimavska Sobota Slovakia 97901
193 Vseobecna nemocnica Rimavska Sobota Rimavska Sobota Slovakia 97901
194 FN Trencin Trencin Slovakia 91101
195 Pro mente sana s.r.o. Trencin Slovakia 91108
196 Fakultna nemocnica Trnava Trnava Slovakia 917 01
197 Fakultna nemocnica s poliklinikou v Ziline Zilina Slovakia 1207
198 MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association Glevakha Ukraine 8631
199 Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3' Kharkiv Ukraine 61068
200 Kyiv Territorial Medical Incorporation 'Psychiatry' Kyiv Ukraine 04080
201 Railway Clinical Hospital #1 of Kiev Railway station of DTGO 'South-Western Railway' Kyiv Ukraine 1030
202 Medical Center Health and Happy Kyiv Ukraine 1034
203 Mnpe 'Regional Clinical Psychiatric Hospital of Kirovohrad Regional Council' Nove, Kropyvnytskiy Ukraine 25491
204 Ternopil RCCPH Depts of Psychiatry #2 (m) & Psychiatry #4 (f) Ternopil I.Ya. Gorbachevskyi SMU Ternopil Ukraine 46020
205 Transcarpathian Regional Narcological Dispensary Uzhgorod Ukraine 88000
206 Zaporizhzhia Regional Clinical Hospital Zaporizhzhia Ukraine 69600
207 Kingsway Hospital Derby United Kingdom DE22 3LZ
208 Synexus Greater Manchester United Kingdom M15 6SX
209 Garden Valleys Resource Centre Harrogate United Kingdom HG1 2PW
210 Kings College Hospital NHS Trust London United Kingdom SE5 8EF
211 Barnes Hospital London United Kingdom SW14 8SU
212 Cornwall Partnership Foundation Trust Redruth United Kingdom TR15 2SP
213 Cherry Knowle Hospital Sunderland United Kingdom SR2 0NB

Sponsors and Collaborators

  • Janssen Research & Development, LLC

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT04513912
Other Study ID Numbers:
  • CR108810
  • 42847922MDD3005
  • 2020-000341-14
First Posted:
Aug 14, 2020
Last Update Posted:
Jul 21, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2022