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
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 |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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.
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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.
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Outcome Measures
Primary Outcome Measures
- 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
- Change from baseline in Weight up to Week 26 [Baseline to Week 26]
Change from baseline in weight will be reported.
- 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).
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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
Inclusion Criteria:
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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
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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)
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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
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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
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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
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Body mass index (BMI) between 18 and 40 kilogram per meter square (kg/m2), inclusive (BMI=weight/height2)
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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:
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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
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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)
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Has history or current diagnosis of a psychotic disorder, bipolar disorder, intellectual disability, autism spectrum disorder, borderline personality disorder, somatoform disorders
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Has a history of moderate to severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening
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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 | |
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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 "Russian University of Peoples' Friendship" | 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 "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.- CR108810
- 42847922MDD3005
- 2020-000341-14