A Study of RO4917838 in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia (NN25310)
NCT ID: NCT01192867
Last Updated: 2017-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
629 participants
INTERVENTIONAL
2010-12-11
2014-05-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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RO4917838 20 milligrams (mg)
Participants, on stable antipsychotics, will receive RO4917838 orally at 20 mg once daily (QD) up to 56 weeks followed by an optional treatment extension for up to 3 years.
RO4917838
RO4917838 will be administered orally at 20 or 10 mg QD for 56 weeks.
Antipshychotics (Standard of Care)
Participants will continue to receive their stable antipshychotic as standard of care based on their prescription up to Week 56.
RO4917838 10 mg
Participants, on stable antipsychotics, will receive RO4917838 orally at 10 mg QD up to 56 weeks followed by an optional treatment extension for up to 3 years.
RO4917838
RO4917838 will be administered orally at 20 or 10 mg QD for 56 weeks.
Antipshychotics (Standard of Care)
Participants will continue to receive their stable antipshychotic as standard of care based on their prescription up to Week 56.
Placebo
Participants, on stable antipsychotics, will receive RO4917838 matching placebo orally QD up to 56 weeks.
Placebo
Placebo will be administered orally QD for 56 weeks
Antipshychotics (Standard of Care)
Participants will continue to receive their stable antipshychotic as standard of care based on their prescription up to Week 56.
Interventions
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Placebo
Placebo will be administered orally QD for 56 weeks
RO4917838
RO4917838 will be administered orally at 20 or 10 mg QD for 56 weeks.
Antipshychotics (Standard of Care)
Participants will continue to receive their stable antipshychotic as standard of care based on their prescription up to Week 56.
Eligibility Criteria
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Inclusion Criteria
* Predominant negative symptoms
* With the exception of clozapine, participants are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of two antipsychotics)
Exclusion Criteria
* Body Mass Index (BMI) of less than (\<) 17 or greater than (\>) 40 kilograms per meter square (kg/m\^2)
* Depressive symptoms, defined as a score of 9 or greater on the Calgary Depression Rating Scale for Schizophrenia (CDSS)
* A severity score of 3 or greater on the Parkinsonism item of the Exrapyramidal Symptoms Rating Scale-Abbreviated (ESRS-A) (Clinical Global Impression, Parkinsonism)
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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K&S Professional Research Services LLC
Little Rock, Arkansas, United States
Advanced Research Center Inc.
Anaheim, California, United States
Comprehensive Clinical Development- Cerritos CA
Cerritos, California, United States
Diligent Clinical Trials Inc
Downey, California, United States
Care Research Center
La Palma, California, United States
Pasadena Research Institute
Pasadena, California, United States
CNRI - Los Angeles, LLC
Pico Rivera, California, United States
Pharmax Research Clinic Inc.
Miami, Florida, United States
Northwest Behavioral Research Center
Marietta, Georgia, United States
American Medical Research, Inc
Oak Brook, Illinois, United States
University of Iowa College of Medicine; Psychiatry Research
Iowa City, Iowa, United States
Clinical Insights, Inc.
Glen Burnie, Maryland, United States
St Louis Clinical Trials
St Louis, Missouri, United States
Ocean Rheumatology
Toms River, New Jersey, United States
CRI Worldwide LLC
Willingboro, New Jersey, United States
Raymond G. Murphy VA Medical Center
Albuquerque, New Mexico, United States
Behavioral Medical Research of Brooklyn
Brooklyn, New York, United States
Comprehensive NeuroScience
Fresh Meadows, New York, United States
North Carolina Psychiatric Research Center
Raleigh, North Carolina, United States
UC Health Clinical Trials Office
Cincinnati, Ohio, United States
Belmont Center for Comprehensive Treatment; Research
Philadelphia, Pennsylvania, United States
Claghorn-Lesem Research Clinic, Inc.
Bellaire, Texas, United States
FutureSearch Clinical Trials, LP
Dallas, Texas, United States
Pillar Clinical Research LLC
Dallas, Texas, United States
Family Psychiatry of the Woodlands P.A.
The Woodlands, Texas, United States
Pacific Institute of Medical Sciences
Bothell, Washington, United States
Eastside Therapeutic Resource
Kirkland, Washington, United States
Centro SERES
Buenos Aires, , Argentina
Fundacion para el Estudio y Tratamiento des las Enfi Mentales
Buenos Aires, , Argentina
Mulieris
CABA, , Argentina
Facene Fund.Argentina Contra Enferm.Neur.Del Envejecimiento
Ciudad Autonoma Bs As, , Argentina
Instituto Nacional de Psicopatologia
Ciudad Autonoma Bs As, , Argentina
Instituto DAMIC - Fundación Rusculleda
Córdoba, , Argentina
Sanatorio Prof.Leon.S.Morra S.A
Córdoba, , Argentina
Instituto de Neurociencias San Agustín S.A.
La Plata, , Argentina
Centro de Psiquiatria Biologica Professor Julio J. Herrera; Psiquiatria
Mendoza, , Argentina
Resolution Psicopharmacology Research Institute
Mendoza, , Argentina
Centro de Asistencia e Investigación en Neurociencias
Mendoza, , Argentina
CIAP - Centro de Investigacion y Asistencia en Psiquiatria
Rosario, , Argentina
Centro de Investigacion Clinica Farmacologica en Psiquiatria
Santiago del Estero, , Argentina
Westmead Hospital; Department of Psychiatry
Westmead, New South Wales, Australia
Monash Medical Centre-Clayton Campus; School of Psychology and Psychiatry
Clayton, Victoria, Australia
Frankston Hospital; Mental Health Service
Frankston, Victoria, Australia
The Alfred Hospital; Monash Alfred Psychiatry Research Centre (MAP-RC)
Melbourne, Victoria, Australia
Centro de Investigaciones y Proyectos en Neurociencias CIPNA
Barranquilla, , Colombia
E.S.E. Hospital Mental de Antioquia
Bello, , Colombia
Centro de Investigaciones del Sistema Nervioso Limitada - Gr
Bogotá, , Colombia
Privater
Kuopio, , Finland
Centre Hospitalier Universitaire Caen; Pôle Psychiatrie - Addictologie
Caen, , France
CHU Gabriel Montpied; Service de Psychiatrie
Clermont-Ferrand, , France
Centre Hospitalier Specialise du Jura
Dole, , France
Cabinet Médical Ambroise Paré
Élancourt, , France
Hôpital de la Conception; Pôle Psychiatrique Centre
Marseille, , France
CHU Strasbourg Nouvel Hôpital Civil;Service de Psychiatrie I
Strasbourg, , France
Hopital Chalucet; Unite de Psychiatrie
Toulon, , France
Dr. Kenessey Albert Hospital; Psychiatry I.
Balassagyarmat, , Hungary
Fov.Onk.Szt Janos Korh. E-Budai Egyesitett Korhazai; Pszichiatriaci rehabilitacio
Budapest, , Hungary
Semmelweis Egyetem AOK; Pszichiatriai es Pszichoterapias Klinika
Budapest, , Hungary
Fovarosi Onkormanyzat Nyiro Gyula Korhaza; Pszichatria II
Budapest, , Hungary
Fovarosi Onkormanyzat Nyiro Gyula Korhaza; Pszichiatria I.
Budapest, , Hungary
UNO Medical Trials Kft.
Budapest, , Hungary
Petz Aladar Megyei Oktato Korhaz; Pszichiatria I.
Győr, , Hungary
Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
Gyula, , Hungary
Samvedna Hospitals; Samvedana Psychiatry and Sex Therapy Hospital
Ahmedabad, , India
Sneh Clinic
Ahmedabad, , India
Gujarat Institute of Psychological Research (GIPS)
Ahmedabad, , India
Mental Health Care & Research
Jaipur, , India
R. K.Yadav Memorial Mental Health & De-Addiction Hospital
Jaipur, , India
Manav Neuropsychiatric Hospital Pvt. Ltd.
Kalyān, , India
Kasturba Medical College & Hospital
Mangalore, , India
K. S. Hegde Medical Academy
Mangalore, , India
Poona Hospital and Research Centre
Pune, , India
Brij Psychiatry Hospital & Muskaan Research Centre; Maanav Health Foundation
Vadodara, , India
Arete Proycectos y Administracion S.C
México, , Mexico
Centro de Investigacion Medica S.C; Hospital Santa Cecilia de Monterrey S.A. de C.V.
Monterrey, , Mexico
Medikalink
Monterrey, , Mexico
Instituto de informacion e investigacion en salud mental AC
Monterrey, , Mexico
Hospital Lomas de San Luis Internacional
San Luis Potosí City, , Mexico
Spitalul Clinic Judetean Arad; Departamentul de Psihiatrie
Arad, , Romania
Spit Univ Urgenta Militar Dr. Carol Davila; Sectia Psihiatrie
Bucharest, , Romania
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Clinical III Psihiatrie
Bucharest, , Romania
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Comunitara si Reintegrare Psihosociala
Bucharest, , Romania
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Sectia Clinica XIII Psihiatrie
Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta Cluj; Sectia Clinica de Psihiatrie III
Cluj-Napoca, , Romania
Spitalul Universitar de Psihiatrie Socola
Lasi, , Romania
Spitalul Clinic Municipal Dr. Gavril Curteanu; Sectia Clinica Psihiatrie I
Oradea, , Romania
Spitalul de Psihiatrie Dr. Gh. Preda Sibiu;CSM Adulti Sibiu
Sibiu, , Romania
Cabinet Medical S.C. Lorentina 2102 S.R.L.; Psihiatrie
Targouiste, , Romania
Kemerovo Regional Clinical Psychiatric Hospital
Kemerovo, , Russia
GUZ Lipetsk Regional psychoneurological Hospital #1; Dispansary Department
Lipetsk, , Russia
Scientifically Research Institute of Psychiatry of Ministry of Health of the Russian Federation
Moscow, , Russia
Institution of RAMS (Mental Health Research Center of RAMS)
Moscow, , Russia
Federal State Institution Moscow SRI of Psychiatry of Minzdravsocrazvitia
Moscow, , Russia
Central Moscow Regional Clinical Psychiatric Hospital
Moscow, , Russia
Moscow Region Psychiatric Hospital #5
Moscow Region, , Russia
City Clinical Psychiatry Hospital #1
Nizhny Novgorod, , Russia
St. Petersburg State Healthcare Institution
Saint Petersburg, , Russia
City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
Saint Petersburg, , Russia
Saint Petersburg Psychoneurological Research Institute of Roszdrav n.a. Bekhterev
Saint Petersburg, , Russia
St. Petersburg GUZ City Psychiatric Hospital #6
Saint Petersburg, , Russia
Military Medical Academy
Saint Petersburg, , Russia
St. Petersburg State Healthcare Institution "City Mental Hospital #3; I.I. Skvortsov-Stepanov
Saint Petersburg, , Russia
Samara Psychiatric Hospital
Samara, , Russia
Mhi City Clinical Hospital #2 Named After v.i. Razumousky
Sartatov, , Russia
Arkhangelsk Regional Clinical Psychiatric Hospital
Talagi, , Russia
Tomsk Clinical Psychiatric Hospital
Tomsk, , Russia
Inje University Busan Paik Hospital
Busan, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Korea University Ansan Hospital
Gyeonggi-do, , South Korea
Inha University Hospital
Incheon, , South Korea
Gil Hospital. Gachon University
Incheon, , South Korea
Chonbuk National Uni Hospital
Jeollabuk-do, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
The Catholic University of Korea St.Mary's Hospital
Seoul, , South Korea
Integrerad Närsjukvård i Malmö
Malmo, , Sweden
Karolinska Universitetssjukhuset Huddinge, Psykiatri Sydväst
Stockholm, , Sweden
Danderyds Sjukhus AB; PRIMA Vuxenpsykiatri
Stockholm, , Sweden
Akademiska Sjukhuset; Psykosvård och rättspsykiatrisk vård
Uppsala, , Sweden
Royal Edinburgh Hospital; Psychiatry
Edinburgh, , United Kingdom
Institute of Pyschiatry
London, , United Kingdom
Wareneford Hospital
Oxford, , United Kingdom
Countries
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References
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Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.
Bugarski-Kirola D, Blaettler T, Arango C, Fleischhacker WW, Garibaldi G, Wang A, Dixon M, Bressan RA, Nasrallah H, Lawrie S, Napieralski J, Ochi-Lohmann T, Reid C, Marder SR. Bitopertin in Negative Symptoms of Schizophrenia-Results From the Phase III FlashLyte and DayLyte Studies. Biol Psychiatry. 2017 Jul 1;82(1):8-16. doi: 10.1016/j.biopsych.2016.11.014. Epub 2016 Dec 15.
Other Identifiers
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2010-020370-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN25310
Identifier Type: -
Identifier Source: org_study_id
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