A Study of RO4917838 in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia (NN25310)
- Conditions
- Schizophrenia
- Interventions
- Drug: RO4917838Drug: PlaceboDrug: Antipshychotics (Standard of Care)
- Registration Number
- NCT01192867
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This multi-center, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 in participants with persistent, predominant negative symptoms of schizophrenia. Participants, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 56 weeks (treatment period 1 of 24 weeks and treatment period 2 of 32 weeks), followed by an optional treatment extension for up to 3 years. After 52 weeks, participants who were originally randomized to an active treatment will be randomly assigned to receive either placebo or continue on the originally assigned study treatment for 4 weeks washout period (Week 52 to Week 56) for the assessment of potential withdrawal effects in a blinded manner using participants staying on active treatment as a control. Participants initially randomized to placebo will remain on placebo. After 56 weeks, participants who were switched to placebo in the washout period will return to their blinded, active treatment arm.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 629
- Diagnosis of schizophrenia of paranoid, disorganized, residual, undifferentiated or catatonic subtype
- 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)
- Evidence that participant has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RO4917838 20 milligrams (mg) Antipshychotics (Standard of Care) 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 20 milligrams (mg) RO4917838 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 10 mg Antipshychotics (Standard of Care) 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. Placebo Placebo Participants, on stable antipsychotics, will receive RO4917838 matching placebo orally QD up to 56 weeks. RO4917838 10 mg RO4917838 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. Placebo Antipshychotics (Standard of Care) Participants, on stable antipsychotics, will receive RO4917838 matching placebo orally QD up to 56 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in the Positive and Negative Symptoms Scales (PANSS) Negative Symptoms Factor Score at Week 24 (All-Participant Population) Baseline, Week 24 Percentage of Participants With Adverse Events (All-Participant Population) Week 24
- Secondary Outcome Measures
Name Time Method Change From Baseline in the PANSS Negative Symptoms Factor Score at Week 24 (Complement Factor H Related Protein 1 High [CFHR1-High] Subgroup Population) Baseline, Week 24 Change From Baseline in the Personal and Social Performance (PSP) Total Score at Week 24 (All-Participant Population) Baseline, Week 24 Change From Baseline in the PSP Total Score at Week 24 (CFHR1-High Subgroup Population) Baseline, Week 24 Change From Baseline in the PANSS Total Score at Week 24 (All-Participant Population) Baseline, Week 24 Change From Baseline in the PANSS Total Score at Week 24 (CFHR1-High Subgroup Population) Baseline, Week 24 Change From Baseline in the PANSS Factor Score at Week 24 (All-Participant Population) Baseline, Week 24 Change From Baseline in the PANSS Factor Score at Week 24 (CFHR1-High Subgroup Population) Baseline, Week 24 Change From Baseline in the PANSS Subscale Scores at Week 24 (All-Participant Population) Baseline, Week 24 Change From Baseline in the PANSS Subscale Scores at Week 24 (CFHR1-High Subgroup Population) Baseline, Week 24 Percentage of Participants Who Have at least 20 Percent (%) Improvement From Baseline in the PANSS Negative Symptom Factor Score at Week 24 (All-Participant Population) Baseline, Week 24 Percentage of Participants Who Have at least 20% Improvement From Baseline in the PANSS Negative Symptom Factor Score at Week 24 (CFHR1-High Subgroup Population) Baseline, Week 24 Percentage of Participants Who Have at least 20% Improvement From Baseline in the PANSS Negative Symptom Factor Score for Two out of Three Assessments During 24 Weeks (All-Participant Population) Baseline up to Week 24 Percentage of Participants Who Have at least 20% Improvement From Baseline in the PANSS Negative Symptom Factor Score for Two out of Three Assessments During 24 Weeks (CFHR1-High Subgroup Population) Baseline up to Week 24 Percentage of Participants With Improvement From Baseline in the Overall Clinical Status Based on Clinical Global Impression - Improvement (CGI-I) Score (All-Participant Population) Baseline, Week 24 Percentage of Participants With Improvement From Baseline in the Overall Clinical Status Based on CGI-I Score (CFHR1 Subgroup Population) Baseline, Week 24 Percentage of Participants With Improvement From Baseline in the Overall Clinical Status Based on CGI-I Score for Two out of Three Assessments During 24 Weeks (All-Participant Population) Baseline up to Week 24 Percentage of Participants With Improvement From Baseline in the Overall Clinical Status Based on CGI-I Score for Two out of Three Assessments During 24 Weeks (CFHR1 Subgroup Population) Baseline up to Week 24 Percentage of Participants With Improvement From Baseline in the Negative Symptoms Based on CGI-I Negative Symptoms Score (All-Participant Population) Baseline, Week 24 Percentage of Participants With Improvement From Baseline in the Negative Symptoms Based on CGI-I Negative Symptoms Score (CFHR1 Subgroup Population) Baseline, Week 24 Percentage of Participants With Improvement From Baseline in the Negative Symptoms Based on CGI-I Negative Symptoms Score for Two out of Three Assessments During 24 Weeks (All-Participant Population) Baseline up to Week 24 Percentage of Participants With Improvement From Baseline in the Negative Symptoms Based on CGI-I Negative Symptoms Score for Two out of Three Assessments During 24 Weeks (CFHR1 Subgroup Population) Baseline up to Week 24 Percentage of Participants Who Have at least 20% Improvement From Baseline in the PANSS Negative Symptom Factor Score at Week 24 and Improvement in the Negative Symptoms Based on CGI-I Negative Symptoms Score (All-Participant Population) Baseline, Week 24 Percentage of Participants Who Have at least 20% Improvement From Baseline in the PANSS Negative Symptom Factor Score at Week 24 and Improvement in the Negative Symptoms Based on CGI-I Negative Symptoms Score (CFHR1 Subgroup Population) Baseline, Week 24 Change From Baseline in Severity of Illness Based on Clinical Global Impression - Severity (CGI-S) Overall Score (All-Participant Population) Baseline, Week 24 Change From Baseline in Severity of Illness Based on CGI-S Overall Score (CFHR1 Subgroup Population) Baseline, Week 24 Change From Baseline in Severity of Illness Based on CGI-S Negative Symptoms Score (All-Participant Population) Baseline, Week 24 Change From Baseline in Severity of Illness Based on CGI-S Negative Symptoms Score (CFHR1 Subgroup Population) Baseline, Week 24
Trial Locations
- Locations (122)
Family Psychiatry of the Woodlands P.A.
🇺🇸The Woodlands, Texas, United States
CNRI - Los Angeles, LLC
🇺🇸Pico Rivera, California, United States
Pillar Clinical Research LLC
🇺🇸Dallas, Texas, United States
Resolution Psicopharmacology Research Institute
🇦🇷Ciudad de Mendoza, Argentina
Sanatorio Prof.Leon.S.Morra S.A
🇦🇷Cordoba, Argentina
Instituto de Neurociencias San Agustín S.A.
🇦🇷La Plata, Argentina
Mental Health Care & Research
🇮🇳Jaipur, India
CIAP - Centro de Investigacion y Asistencia en Psiquiatria
🇦🇷Rosario, Argentina
Hôpital de la Conception; Pôle Psychiatrique Centre
🇫🇷Marseille, France
R. K.Yadav Memorial Mental Health & De-Addiction Hospital
🇮🇳Jaipur, India
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Instituto de informacion e investigacion en salud mental AC
🇲🇽Monterrey, Mexico
CHU Strasbourg Nouvel Hôpital Civil;Service de Psychiatrie I
🇫🇷Strasbourg, France
Poona Hospital and Research Centre
🇮🇳Pune, India
Ocean Rheumatology
🇺🇸Toms River, New Jersey, United States
The Alfred Hospital; Monash Alfred Psychiatry Research Centre (MAP-RC)
🇦🇺Melbourne, Victoria, Australia
CRI Worldwide LLC
🇺🇸Willingboro, New Jersey, United States
Centro de Asistencia e Investigación en Neurociencias
🇦🇷Mendoza, Argentina
Centro de Investigaciones del Sistema Nervioso Limitada - Gr
🇨🇴Bogota, Colombia
Centre Hospitalier Universitaire Caen; Pôle Psychiatrie - Addictologie
🇫🇷Caen, France
Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
🇭🇺Gyula, Hungary
Samvedna Hospitals; Samvedana Psychiatry and Sex Therapy Hospital
🇮🇳Ahmedabad, India
K. S. Hegde Medical Academy
🇮🇳Mangalore, India
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Comunitara si Reintegrare Psihosociala
🇷🇴Bucuresti, Romania
GUZ Lipetsk Regional psychoneurological Hospital #1; Dispansary Department
🇷🇺Lipetsk, Russian Federation
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
City Clinical Psychiatry Hospital #1
🇷🇺Nizhny Novgorod, Russian Federation
City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
🇷🇺St. Petersburg, Russian Federation
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
CHU Gabriel Montpied; Service de Psychiatrie
🇫🇷Clermont-ferrand, France
Gujarat Institute of Psychological Research (GIPS)
🇮🇳Ahmedabad, India
Hospital Lomas de San Luis Internacional
🇲🇽San Luis Potosi, Mexico
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Sectia Clinica XIII Psihiatrie
🇷🇴Bucuresti, Romania
St. Petersburg State Healthcare Institution "City Mental Hospital #3; I.I. Skvortsov-Stepanov
🇷🇺St Petersburg, Russian Federation
Arkhangelsk Regional Clinical Psychiatric Hospital
🇷🇺Talagi, Russian Federation
Fovarosi Onkormanyzat Nyiro Gyula Korhaza; Pszichatria II
🇭🇺Budapest, Hungary
Federal State Institution Moscow SRI of Psychiatry of Minzdravsocrazvitia
🇷🇺Moscow, Russian Federation
Chonbuk National Uni Hospital
🇰🇷Jeollabuk-do, Korea, Republic of
Kemerovo Regional Clinical Psychiatric Hospital
🇷🇺Kemerovo, Russian Federation
The Catholic University of Korea St.Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Spitalul Clinic Judetean de Urgenta Cluj; Sectia Clinica de Psihiatrie III
🇷🇴Cluj-Napoca, Romania
Military Medical Academy
🇷🇺Saint Petersburg, Russian Federation
Mhi City Clinical Hospital #2 Named After v.i. Razumousky
🇷🇺Sartatov, Russian Federation
St. Petersburg State Healthcare Institution
🇷🇺St Petersbourg, Russian Federation
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Spitalul Universitar de Psihiatrie Socola
🇷🇴Lasi, Romania
St. Petersburg GUZ City Psychiatric Hospital #6
🇷🇺St Petersburg, Russian Federation
Tomsk Clinical Psychiatric Hospital
🇷🇺Tomsk, Russian Federation
K&S Professional Research Services LLC
🇺🇸Little Rock, Arkansas, United States
Comprehensive Clinical Development- Cerritos CA
🇺🇸Cerritos, California, United States
Care Research Center
🇺🇸La Palma, California, United States
Comprehensive NeuroScience
🇺🇸Fresh Meadows, New York, United States
North Carolina Psychiatric Research Center
🇺🇸Raleigh, North Carolina, United States
Fundacion para el Estudio y Tratamiento des las Enfi Mentales
🇦🇷Buenos Aires, Argentina
Facene Fund.Argentina Contra Enferm.Neur.Del Envejecimiento
🇦🇷Ciudad Autonoma Bs As, Argentina
Instituto Nacional de Psicopatologia
🇦🇷Ciudad Autonoma Bs As, Argentina
Centro SERES
🇦🇷Buenos Aires, Argentina
Mulieris
🇦🇷Caba, Argentina
Frankston Hospital; Mental Health Service
🇦🇺Frankston, Victoria, Australia
Centro de Investigaciones y Proyectos en Neurociencias CIPNA
🇨🇴Barranquilla, Colombia
Cabinet Médical Ambroise Paré
🇫🇷Elancourt, France
UNO Medical Trials Kft.
🇭🇺Budapest, Hungary
Petz Aladar Megyei Oktato Korhaz; Pszichiatria I.
🇭🇺Gyor, Hungary
Sneh Clinic
🇮🇳Ahmedabad, India
Kasturba Medical College & Hospital
🇮🇳Mangalore, India
Manav Neuropsychiatric Hospital Pvt. Ltd.
🇮🇳Kalyan, India
Brij Psychiatry Hospital & Muskaan Research Centre; Maanav Health Foundation
🇮🇳Vadodara, India
Gil Hospital. Gachon University
🇰🇷Incheon, Korea, Republic of
Centro de Investigacion Medica S.C; Hospital Santa Cecilia de Monterrey S.A. de C.V.
🇲🇽Monterrey, Mexico
Medikalink
🇲🇽Monterrey, Mexico
Spitalul Clinic Judetean Arad; Departamentul de Psihiatrie
🇷🇴Arad, Romania
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Clinical III Psihiatrie
🇷🇴Bucuresti, Romania
Karolinska Universitetssjukhuset Huddinge, Psykiatri Sydväst
🇸🇪Stockholm, Sweden
Wareneford Hospital
🇬🇧Oxford, United Kingdom
Arete Proycectos y Administracion S.C
🇲🇽Mexico, Mexico
Spit Univ Urgenta Militar Dr. Carol Davila; Sectia Psihiatrie
🇷🇴Bucuresti, 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
Integrerad Närsjukvård i Malmö
🇸🇪Malmö, Sweden
Danderyds Sjukhus AB; PRIMA Vuxenpsykiatri
🇸🇪Stockholm, Sweden
Royal Edinburgh Hospital; Psychiatry
🇬🇧Edinburgh, United Kingdom
Moscow Region Psychiatric Hospital #5
🇷🇺Moscow Region, Russian Federation
Scientifically Research Institute of Psychiatry of Ministry of Health of the Russian Federation
🇷🇺Moscow, Russian Federation
Institution of RAMS (Mental Health Research Center of RAMS)
🇷🇺Moscow, Russian Federation
Samara Psychiatric Hospital
🇷🇺Samara, Russian Federation
Akademiska Sjukhuset; Psykosvård och rättspsykiatrisk vård
🇸🇪Uppsala, Sweden
Saint Petersburg Psychoneurological Research Institute of Roszdrav n.a. Bekhterev
🇷🇺St. Petersburg, Russian Federation
Institute of Pyschiatry
🇬🇧London, United Kingdom
UC Health Clinical Trials Office
🇺🇸Cincinnati, Ohio, United States
Advanced Research Center Inc.
🇺🇸Anaheim, California, United States
Pasadena Research Institute
🇺🇸Pasadena, California, United States
St Louis Clinical Trials
🇺🇸Saint Louis, Missouri, United States
American Medical Research, Inc
🇺🇸Oak Brook, Illinois, United States
Northwest Behavioral Research Center
🇺🇸Marietta, Georgia, United States
University of Iowa College of Medicine; Psychiatry Research
🇺🇸Iowa City, Iowa, United States
Raymond G. Murphy VA Medical Center
🇺🇸Albuquerque, New Mexico, United States
Clinical Insights, Inc.
🇺🇸Glen Burnie, Maryland, United States
Behavioral Medical Research of Brooklyn
🇺🇸Brooklyn, New York, United States
FutureSearch Clinical Trials, LP
🇺🇸Dallas, Texas, United States
Belmont Center for Comprehensive Treatment; Research
🇺🇸Philadelphia, Pennsylvania, United States
Claghorn-Lesem Research Clinic, Inc.
🇺🇸Bellaire, Texas, United States
Eastside Therapeutic Resource
🇺🇸Kirkland, Washington, United States
Pacific Institute of Medical Sciences
🇺🇸Bothell, Washington, United States
Instituto DAMIC - Fundación Rusculleda
🇦🇷Cordoba, Argentina
Centro de Psiquiatria Biologica Professor Julio J. Herrera; Psiquiatria
🇦🇷Mendoza, Argentina
Westmead Hospital; Department of Psychiatry
🇦🇺Westmead, New South Wales, Australia
Monash Medical Centre-Clayton Campus; School of Psychology and Psychiatry
🇦🇺Clayton, Victoria, Australia
Centro de Investigacion Clinica Farmacologica en Psiquiatria
🇦🇷Santiago del Estero, Argentina
Centre Hospitalier Specialise du Jura
🇫🇷Dole, France
E.S.E. Hospital Mental de Antioquia
🇨🇴Bello, Colombia
Privater
🇫🇮Kuopio, Finland
Dr. Kenessey Albert Hospital; Psychiatry I.
🇭🇺Balassagyarmat, Hungary
Hopital Chalucet; Unite de Psychiatrie
🇫🇷Toulon, France
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; Pszichiatria I.
🇭🇺Budapest, Hungary
Cabinet Medical S.C. Lorentina 2102 S.R.L.; Psihiatrie
🇷🇴Targouiste, Romania
Pharmax Research Clinic Inc.
🇺🇸Miami, Florida, United States
Diligent Clinical Trials Inc
🇺🇸Downey, California, United States
Central Moscow Regional Clinical Psychiatric Hospital
🇷🇺Moscow, Russian Federation