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A Study of RO4917838 in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia (NN25310)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
RO4917838
Antipshychotics (Standard of Care)
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

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

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Sites / Locations

  • K&S Professional Research Services LLC
  • Advanced Research Center Inc.
  • Comprehensive Clinical Development- Cerritos CA
  • Diligent Clinical Trials Inc
  • Care Research Center
  • Pasadena Research Institute
  • CNRI - Los Angeles, LLC
  • Pharmax Research Clinic Inc.
  • Northwest Behavioral Research Center
  • American Medical Research, Inc
  • University of Iowa College of Medicine; Psychiatry Research
  • Clinical Insights, Inc.
  • St Louis Clinical Trials
  • Ocean Rheumatology
  • CRI Worldwide LLC
  • Raymond G. Murphy VA Medical Center
  • Behavioral Medical Research of Brooklyn
  • Comprehensive NeuroScience
  • North Carolina Psychiatric Research Center
  • UC Health Clinical Trials Office
  • Belmont Center for Comprehensive Treatment; Research
  • Claghorn-Lesem Research Clinic, Inc.
  • FutureSearch Clinical Trials, LP
  • Pillar Clinical Research LLC
  • Family Psychiatry of the Woodlands P.A.
  • Pacific Institute of Medical Sciences
  • Eastside Therapeutic Resource
  • Centro SERES
  • Fundacion para el Estudio y Tratamiento des las Enfi Mentales
  • Mulieris
  • Facene Fund.Argentina Contra Enferm.Neur.Del Envejecimiento
  • Instituto Nacional de Psicopatologia
  • Resolution Psicopharmacology Research Institute
  • Instituto DAMIC - Fundación Rusculleda
  • Sanatorio Prof.Leon.S.Morra S.A
  • Instituto de Neurociencias San Agustín S.A.
  • Centro de Psiquiatria Biologica Professor Julio J. Herrera; Psiquiatria
  • Centro de Asistencia e Investigación en Neurociencias
  • CIAP - Centro de Investigacion y Asistencia en Psiquiatria
  • Centro de Investigacion Clinica Farmacologica en Psiquiatria
  • Westmead Hospital; Department of Psychiatry
  • Monash Medical Centre-Clayton Campus; School of Psychology and Psychiatry
  • Frankston Hospital; Mental Health Service
  • The Alfred Hospital; Monash Alfred Psychiatry Research Centre (MAP-RC)
  • Centro de Investigaciones y Proyectos en Neurociencias CIPNA
  • E.S.E. Hospital Mental de Antioquia
  • Centro de Investigaciones del Sistema Nervioso Limitada - Gr
  • Privater
  • Centre Hospitalier Universitaire Caen; Pôle Psychiatrie - Addictologie
  • CHU Gabriel Montpied; Service de Psychiatrie
  • Centre Hospitalier Specialise du Jura
  • Cabinet Médical Ambroise Paré
  • Hôpital de la Conception; Pôle Psychiatrique Centre
  • CHU Strasbourg Nouvel Hôpital Civil;Service de Psychiatrie I
  • Hopital Chalucet; Unite de Psychiatrie
  • Dr. Kenessey Albert Hospital; Psychiatry I.
  • Fov.Onk.Szt Janos Korh. E-Budai Egyesitett Korhazai; Pszichiatriaci rehabilitacio
  • Semmelweis Egyetem AOK; Pszichiatriai es Pszichoterapias Klinika
  • Fovarosi Onkormanyzat Nyiro Gyula Korhaza; Pszichatria II
  • Fovarosi Onkormanyzat Nyiro Gyula Korhaza; Pszichiatria I.
  • UNO Medical Trials Kft.
  • Petz Aladar Megyei Oktato Korhaz; Pszichiatria I.
  • Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
  • Samvedna Hospitals; Samvedana Psychiatry and Sex Therapy Hospital
  • Sneh Clinic
  • Gujarat Institute of Psychological Research (GIPS)
  • Mental Health Care & Research
  • R. K.Yadav Memorial Mental Health & De-Addiction Hospital
  • Manav Neuropsychiatric Hospital Pvt. Ltd.
  • Kasturba Medical College & Hospital
  • K. S. Hegde Medical Academy
  • Poona Hospital and Research Centre
  • Brij Psychiatry Hospital & Muskaan Research Centre; Maanav Health Foundation
  • Inje University Busan Paik Hospital
  • Chonnam National University Hospital
  • Korea University Ansan Hospital
  • Inha University Hospital
  • Gil Hospital. Gachon University
  • Chonbuk National Uni Hospital
  • Korea University Anam Hospital
  • Seoul National University Hospital
  • The Catholic University of Korea St.Mary's Hospital
  • Arete Proycectos y Administracion S.C
  • Centro de Investigacion Medica S.C; Hospital Santa Cecilia de Monterrey S.A. de C.V.
  • Medikalink
  • Instituto de informacion e investigacion en salud mental AC
  • Hospital Lomas de San Luis Internacional
  • Spitalul Clinic Judetean Arad; Departamentul de Psihiatrie
  • Spit Univ Urgenta Militar Dr. Carol Davila; Sectia Psihiatrie
  • Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Clinical III Psihiatrie
  • Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Comunitara si Reintegrare Psihosociala
  • Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Sectia Clinica XIII Psihiatrie
  • Spitalul Clinic Judetean de Urgenta Cluj; Sectia Clinica de Psihiatrie III
  • Spitalul Universitar de Psihiatrie Socola
  • Spitalul Clinic Municipal Dr. Gavril Curteanu; Sectia Clinica Psihiatrie I
  • Spitalul de Psihiatrie Dr. Gh. Preda Sibiu;CSM Adulti Sibiu
  • Cabinet Medical S.C. Lorentina 2102 S.R.L.; Psihiatrie
  • Kemerovo Regional Clinical Psychiatric Hospital
  • GUZ Lipetsk Regional psychoneurological Hospital #1; Dispansary Department
  • Moscow Region Psychiatric Hospital #5
  • Scientifically Research Institute of Psychiatry of Ministry of Health of the Russian Federation
  • Institution of RAMS (Mental Health Research Center of RAMS)
  • Federal State Institution Moscow SRI of Psychiatry of Minzdravsocrazvitia
  • Central Moscow Regional Clinical Psychiatric Hospital
  • City Clinical Psychiatry Hospital #1
  • Military Medical Academy
  • Samara Psychiatric Hospital
  • Mhi City Clinical Hospital #2 Named After v.i. Razumousky
  • St. Petersburg State Healthcare Institution
  • St. Petersburg GUZ City Psychiatric Hospital #6
  • St. Petersburg State Healthcare Institution "City Mental Hospital #3; I.I. Skvortsov-Stepanov
  • City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
  • Saint Petersburg Psychoneurological Research Institute of Roszdrav n.a. Bekhterev
  • Arkhangelsk Regional Clinical Psychiatric Hospital
  • Tomsk Clinical Psychiatric Hospital
  • Integrerad Närsjukvård i Malmö
  • Karolinska Universitetssjukhuset Huddinge, Psykiatri Sydväst
  • Danderyds Sjukhus AB; PRIMA Vuxenpsykiatri
  • Akademiska Sjukhuset; Psykosvård och rättspsykiatrisk vård
  • Royal Edinburgh Hospital; Psychiatry
  • Institute of Pyschiatry
  • Wareneford Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

RO4917838 20 milligrams (mg)

RO4917838 10 mg

Placebo

Arm Description

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.

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.

Participants, on stable antipsychotics, will receive RO4917838 matching placebo orally QD up to 56 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline in the Positive and Negative Symptoms Scales (PANSS) Negative Symptoms Factor Score at Week 24 (All-Participant Population)
Percentage of Participants With Adverse Events (All-Participant Population)

Secondary Outcome Measures

Change From Baseline in the PANSS Negative Symptoms Factor Score at Week 24 (Complement Factor H Related Protein 1 High [CFHR1-High] Subgroup Population)
Change From Baseline in the Personal and Social Performance (PSP) Total Score at Week 24 (All-Participant Population)
Change From Baseline in the PSP Total Score at Week 24 (CFHR1-High Subgroup Population)
Change From Baseline in the PANSS Total Score at Week 24 (All-Participant Population)
Change From Baseline in the PANSS Total Score at Week 24 (CFHR1-High Subgroup Population)
Change From Baseline in the PANSS Factor Score at Week 24 (All-Participant Population)
Change From Baseline in the PANSS Factor Score at Week 24 (CFHR1-High Subgroup Population)
Change From Baseline in the PANSS Subscale Scores at Week 24 (All-Participant Population)
Change From Baseline in the PANSS Subscale Scores at Week 24 (CFHR1-High Subgroup Population)
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)
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)
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)
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)
Percentage of Participants With Improvement From Baseline in the Overall Clinical Status Based on Clinical Global Impression - Improvement (CGI-I) Score (All-Participant Population)
Percentage of Participants With Improvement From Baseline in the Overall Clinical Status Based on CGI-I Score (CFHR1 Subgroup Population)
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)
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)
Percentage of Participants With Improvement From Baseline in the Negative Symptoms Based on CGI-I Negative Symptoms Score (All-Participant Population)
Percentage of Participants With Improvement From Baseline in the Negative Symptoms Based on CGI-I Negative Symptoms Score (CFHR1 Subgroup Population)
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)
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)
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)
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)
Change From Baseline in Severity of Illness Based on Clinical Global Impression - Severity (CGI-S) Overall Score (All-Participant Population)
Change From Baseline in Severity of Illness Based on CGI-S Overall Score (CFHR1 Subgroup Population)
Change From Baseline in Severity of Illness Based on CGI-S Negative Symptoms Score (All-Participant Population)
Change From Baseline in Severity of Illness Based on CGI-S Negative Symptoms Score (CFHR1 Subgroup Population)

Full Information

First Posted
August 30, 2010
Last Updated
June 23, 2017
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01192867
Brief Title
A Study of RO4917838 in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia (NN25310)
Official Title
A Phase III, Multi-Center, Randomized, 24 Week, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate Efficacy and Safety of RO4917838 in Stable Patients With Persistent, Predominant Negative Symptoms of Schizophrenia Treated With Antipsychotics Followed by a 28 Week, Double-Blind Treatment Period
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
December 11, 2010 (Actual)
Primary Completion Date
May 26, 2014 (Actual)
Study Completion Date
May 26, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
RO4917838 20 milligrams (mg)
Arm Type
Experimental
Arm Description
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.
Arm Title
RO4917838 10 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants, on stable antipsychotics, will receive RO4917838 matching placebo orally QD up to 56 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered orally QD for 56 weeks
Intervention Type
Drug
Intervention Name(s)
RO4917838
Intervention Description
RO4917838 will be administered orally at 20 or 10 mg QD for 56 weeks.
Intervention Type
Drug
Intervention Name(s)
Antipshychotics (Standard of Care)
Intervention Description
Participants will continue to receive their stable antipshychotic as standard of care based on their prescription up to Week 56.
Primary Outcome Measure Information:
Title
Change From Baseline in the Positive and Negative Symptoms Scales (PANSS) Negative Symptoms Factor Score at Week 24 (All-Participant Population)
Time Frame
Baseline, Week 24
Title
Percentage of Participants With Adverse Events (All-Participant Population)
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in the PANSS Negative Symptoms Factor Score at Week 24 (Complement Factor H Related Protein 1 High [CFHR1-High] Subgroup Population)
Time Frame
Baseline, Week 24
Title
Change From Baseline in the Personal and Social Performance (PSP) Total Score at Week 24 (All-Participant Population)
Time Frame
Baseline, Week 24
Title
Change From Baseline in the PSP Total Score at Week 24 (CFHR1-High Subgroup Population)
Time Frame
Baseline, Week 24
Title
Change From Baseline in the PANSS Total Score at Week 24 (All-Participant Population)
Time Frame
Baseline, Week 24
Title
Change From Baseline in the PANSS Total Score at Week 24 (CFHR1-High Subgroup Population)
Time Frame
Baseline, Week 24
Title
Change From Baseline in the PANSS Factor Score at Week 24 (All-Participant Population)
Time Frame
Baseline, Week 24
Title
Change From Baseline in the PANSS Factor Score at Week 24 (CFHR1-High Subgroup Population)
Time Frame
Baseline, Week 24
Title
Change From Baseline in the PANSS Subscale Scores at Week 24 (All-Participant Population)
Time Frame
Baseline, Week 24
Title
Change From Baseline in the PANSS Subscale Scores at Week 24 (CFHR1-High Subgroup Population)
Time Frame
Baseline, Week 24
Title
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)
Time Frame
Baseline, Week 24
Title
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)
Time Frame
Baseline, Week 24
Title
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)
Time Frame
Baseline up to Week 24
Title
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)
Time Frame
Baseline up to Week 24
Title
Percentage of Participants With Improvement From Baseline in the Overall Clinical Status Based on Clinical Global Impression - Improvement (CGI-I) Score (All-Participant Population)
Time Frame
Baseline, Week 24
Title
Percentage of Participants With Improvement From Baseline in the Overall Clinical Status Based on CGI-I Score (CFHR1 Subgroup Population)
Time Frame
Baseline, Week 24
Title
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)
Time Frame
Baseline up to Week 24
Title
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)
Time Frame
Baseline up to Week 24
Title
Percentage of Participants With Improvement From Baseline in the Negative Symptoms Based on CGI-I Negative Symptoms Score (All-Participant Population)
Time Frame
Baseline, Week 24
Title
Percentage of Participants With Improvement From Baseline in the Negative Symptoms Based on CGI-I Negative Symptoms Score (CFHR1 Subgroup Population)
Time Frame
Baseline, Week 24
Title
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)
Time Frame
Baseline up to Week 24
Title
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)
Time Frame
Baseline up to Week 24
Title
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)
Time Frame
Baseline, Week 24
Title
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)
Time Frame
Baseline, Week 24
Title
Change From Baseline in Severity of Illness Based on Clinical Global Impression - Severity (CGI-S) Overall Score (All-Participant Population)
Time Frame
Baseline, Week 24
Title
Change From Baseline in Severity of Illness Based on CGI-S Overall Score (CFHR1 Subgroup Population)
Time Frame
Baseline, Week 24
Title
Change From Baseline in Severity of Illness Based on CGI-S Negative Symptoms Score (All-Participant Population)
Time Frame
Baseline, Week 24
Title
Change From Baseline in Severity of Illness Based on CGI-S Negative Symptoms Score (CFHR1 Subgroup Population)
Time Frame
Baseline, Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
K&S Professional Research Services LLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72201
Country
United States
Facility Name
Advanced Research Center Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Comprehensive Clinical Development- Cerritos CA
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Diligent Clinical Trials Inc
City
Downey
State/Province
California
ZIP/Postal Code
90241
Country
United States
Facility Name
Care Research Center
City
La Palma
State/Province
California
ZIP/Postal Code
90623
Country
United States
Facility Name
Pasadena Research Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91106
Country
United States
Facility Name
CNRI - Los Angeles, LLC
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
Pharmax Research Clinic Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Northwest Behavioral Research Center
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
American Medical Research, Inc
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
University of Iowa College of Medicine; Psychiatry Research
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Clinical Insights, Inc.
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
St Louis Clinical Trials
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Ocean Rheumatology
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08775
Country
United States
Facility Name
CRI Worldwide LLC
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
Raymond G. Murphy VA Medical Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Behavioral Medical Research of Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Comprehensive NeuroScience
City
Fresh Meadows
State/Province
New York
ZIP/Postal Code
11366
Country
United States
Facility Name
North Carolina Psychiatric Research Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27603
Country
United States
Facility Name
UC Health Clinical Trials Office
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Belmont Center for Comprehensive Treatment; Research
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19131
Country
United States
Facility Name
Claghorn-Lesem Research Clinic, Inc.
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
FutureSearch Clinical Trials, LP
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pillar Clinical Research LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Family Psychiatry of the Woodlands P.A.
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
Facility Name
Pacific Institute of Medical Sciences
City
Bothell
State/Province
Washington
ZIP/Postal Code
98011
Country
United States
Facility Name
Eastside Therapeutic Resource
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
Facility Name
Centro SERES
City
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Fundacion para el Estudio y Tratamiento des las Enfi Mentales
City
Buenos Aires
ZIP/Postal Code
C1425AHQ
Country
Argentina
Facility Name
Mulieris
City
Caba
ZIP/Postal Code
C1022AAO
Country
Argentina
Facility Name
Facene Fund.Argentina Contra Enferm.Neur.Del Envejecimiento
City
Ciudad Autonoma Bs As
ZIP/Postal Code
1117
Country
Argentina
Facility Name
Instituto Nacional de Psicopatologia
City
Ciudad Autonoma Bs As
ZIP/Postal Code
1405
Country
Argentina
Facility Name
Resolution Psicopharmacology Research Institute
City
Ciudad de Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Instituto DAMIC - Fundación Rusculleda
City
Cordoba
ZIP/Postal Code
5003
Country
Argentina
Facility Name
Sanatorio Prof.Leon.S.Morra S.A
City
Cordoba
ZIP/Postal Code
X5009BIN
Country
Argentina
Facility Name
Instituto de Neurociencias San Agustín S.A.
City
La Plata
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Centro de Psiquiatria Biologica Professor Julio J. Herrera; Psiquiatria
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Centro de Asistencia e Investigación en Neurociencias
City
Mendoza
Country
Argentina
Facility Name
CIAP - Centro de Investigacion y Asistencia en Psiquiatria
City
Rosario
ZIP/Postal Code
S2000QJI
Country
Argentina
Facility Name
Centro de Investigacion Clinica Farmacologica en Psiquiatria
City
Santiago del Estero
ZIP/Postal Code
4200
Country
Argentina
Facility Name
Westmead Hospital; Department of Psychiatry
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Monash Medical Centre-Clayton Campus; School of Psychology and Psychiatry
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Frankston Hospital; Mental Health Service
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
The Alfred Hospital; Monash Alfred Psychiatry Research Centre (MAP-RC)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Centro de Investigaciones y Proyectos en Neurociencias CIPNA
City
Barranquilla
Country
Colombia
Facility Name
E.S.E. Hospital Mental de Antioquia
City
Bello
Country
Colombia
Facility Name
Centro de Investigaciones del Sistema Nervioso Limitada - Gr
City
Bogota
Country
Colombia
Facility Name
Privater
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
Facility Name
Centre Hospitalier Universitaire Caen; Pôle Psychiatrie - Addictologie
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CHU Gabriel Montpied; Service de Psychiatrie
City
Clermont-ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Centre Hospitalier Specialise du Jura
City
Dole
ZIP/Postal Code
39100
Country
France
Facility Name
Cabinet Médical Ambroise Paré
City
Elancourt
ZIP/Postal Code
78990
Country
France
Facility Name
Hôpital de la Conception; Pôle Psychiatrique Centre
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
CHU Strasbourg Nouvel Hôpital Civil;Service de Psychiatrie I
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Hopital Chalucet; Unite de Psychiatrie
City
Toulon
ZIP/Postal Code
83000
Country
France
Facility Name
Dr. Kenessey Albert Hospital; Psychiatry I.
City
Balassagyarmat
ZIP/Postal Code
2660
Country
Hungary
Facility Name
Fov.Onk.Szt Janos Korh. E-Budai Egyesitett Korhazai; Pszichiatriaci rehabilitacio
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
Facility Name
Semmelweis Egyetem AOK; Pszichiatriai es Pszichoterapias Klinika
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
Facility Name
Fovarosi Onkormanyzat Nyiro Gyula Korhaza; Pszichatria II
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Fovarosi Onkormanyzat Nyiro Gyula Korhaza; Pszichiatria I.
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
UNO Medical Trials Kft.
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz; Pszichiatria I.
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
City
Gyula
ZIP/Postal Code
5703
Country
Hungary
Facility Name
Samvedna Hospitals; Samvedana Psychiatry and Sex Therapy Hospital
City
Ahmedabad
ZIP/Postal Code
380006
Country
India
Facility Name
Sneh Clinic
City
Ahmedabad
ZIP/Postal Code
380008
Country
India
Facility Name
Gujarat Institute of Psychological Research (GIPS)
City
Ahmedabad
ZIP/Postal Code
380015
Country
India
Facility Name
Mental Health Care & Research
City
Jaipur
ZIP/Postal Code
302017
Country
India
Facility Name
R. K.Yadav Memorial Mental Health & De-Addiction Hospital
City
Jaipur
ZIP/Postal Code
302021
Country
India
Facility Name
Manav Neuropsychiatric Hospital Pvt. Ltd.
City
Kalyan
ZIP/Postal Code
421301
Country
India
Facility Name
Kasturba Medical College & Hospital
City
Mangalore
ZIP/Postal Code
575001
Country
India
Facility Name
K. S. Hegde Medical Academy
City
Mangalore
ZIP/Postal Code
575018
Country
India
Facility Name
Poona Hospital and Research Centre
City
Pune
ZIP/Postal Code
411030
Country
India
Facility Name
Brij Psychiatry Hospital & Muskaan Research Centre; Maanav Health Foundation
City
Vadodara
ZIP/Postal Code
390001
Country
India
Facility Name
Inje University Busan Paik Hospital
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Korea University Ansan Hospital
City
Gyeonggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Gil Hospital. Gachon University
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Chonbuk National Uni Hospital
City
Jeollabuk-do
ZIP/Postal Code
561-712
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
The Catholic University of Korea St.Mary's Hospital
City
Seoul
ZIP/Postal Code
150-713
Country
Korea, Republic of
Facility Name
Arete Proycectos y Administracion S.C
City
Mexico
ZIP/Postal Code
05300
Country
Mexico
Facility Name
Centro de Investigacion Medica S.C; Hospital Santa Cecilia de Monterrey S.A. de C.V.
City
Monterrey
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Medikalink
City
Monterrey
ZIP/Postal Code
64060
Country
Mexico
Facility Name
Instituto de informacion e investigacion en salud mental AC
City
Monterrey
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Hospital Lomas de San Luis Internacional
City
San Luis Potosi
ZIP/Postal Code
72818
Country
Mexico
Facility Name
Spitalul Clinic Judetean Arad; Departamentul de Psihiatrie
City
Arad
ZIP/Postal Code
310022
Country
Romania
Facility Name
Spit Univ Urgenta Militar Dr. Carol Davila; Sectia Psihiatrie
City
Bucuresti
ZIP/Postal Code
010825
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Clinical III Psihiatrie
City
Bucuresti
ZIP/Postal Code
041914
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Comunitara si Reintegrare Psihosociala
City
Bucuresti
ZIP/Postal Code
041914
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Sectia Clinica XIII Psihiatrie
City
Bucuresti
ZIP/Postal Code
041914
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Cluj; Sectia Clinica de Psihiatrie III
City
Cluj-Napoca
ZIP/Postal Code
400012
Country
Romania
Facility Name
Spitalul Universitar de Psihiatrie Socola
City
Lasi
ZIP/Postal Code
700282
Country
Romania
Facility Name
Spitalul Clinic Municipal Dr. Gavril Curteanu; Sectia Clinica Psihiatrie I
City
Oradea
ZIP/Postal Code
410154
Country
Romania
Facility Name
Spitalul de Psihiatrie Dr. Gh. Preda Sibiu;CSM Adulti Sibiu
City
Sibiu
ZIP/Postal Code
550082
Country
Romania
Facility Name
Cabinet Medical S.C. Lorentina 2102 S.R.L.; Psihiatrie
City
Targouiste
ZIP/Postal Code
130081
Country
Romania
Facility Name
Kemerovo Regional Clinical Psychiatric Hospital
City
Kemerovo
ZIP/Postal Code
650036
Country
Russian Federation
Facility Name
GUZ Lipetsk Regional psychoneurological Hospital #1; Dispansary Department
City
Lipetsk
ZIP/Postal Code
399313
Country
Russian Federation
Facility Name
Moscow Region Psychiatric Hospital #5
City
Moscow Region
ZIP/Postal Code
142601
Country
Russian Federation
Facility Name
Scientifically Research Institute of Psychiatry of Ministry of Health of the Russian Federation
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
Facility Name
Institution of RAMS (Mental Health Research Center of RAMS)
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Federal State Institution Moscow SRI of Psychiatry of Minzdravsocrazvitia
City
Moscow
ZIP/Postal Code
117995
Country
Russian Federation
Facility Name
Central Moscow Regional Clinical Psychiatric Hospital
City
Moscow
ZIP/Postal Code
127083
Country
Russian Federation
Facility Name
City Clinical Psychiatry Hospital #1
City
Nizhny Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Facility Name
Military Medical Academy
City
Saint Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Samara Psychiatric Hospital
City
Samara
ZIP/Postal Code
443016
Country
Russian Federation
Facility Name
Mhi City Clinical Hospital #2 Named After v.i. Razumousky
City
Sartatov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
St. Petersburg State Healthcare Institution
City
St Petersbourg
ZIP/Postal Code
190005
Country
Russian Federation
Facility Name
St. Petersburg GUZ City Psychiatric Hospital #6
City
St Petersburg
ZIP/Postal Code
193167
Country
Russian Federation
Facility Name
St. Petersburg State Healthcare Institution "City Mental Hospital #3; I.I. Skvortsov-Stepanov
City
St Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
Saint Petersburg Psychoneurological Research Institute of Roszdrav n.a. Bekhterev
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
Arkhangelsk Regional Clinical Psychiatric Hospital
City
Talagi
ZIP/Postal Code
163530
Country
Russian Federation
Facility Name
Tomsk Clinical Psychiatric Hospital
City
Tomsk
ZIP/Postal Code
634014
Country
Russian Federation
Facility Name
Integrerad Närsjukvård i Malmö
City
Malmö
ZIP/Postal Code
21135
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset Huddinge, Psykiatri Sydväst
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Danderyds Sjukhus AB; PRIMA Vuxenpsykiatri
City
Stockholm
ZIP/Postal Code
18288
Country
Sweden
Facility Name
Akademiska Sjukhuset; Psykosvård och rättspsykiatrisk vård
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Royal Edinburgh Hospital; Psychiatry
City
Edinburgh
ZIP/Postal Code
EH10 5HF
Country
United Kingdom
Facility Name
Institute of Pyschiatry
City
London
ZIP/Postal Code
SE5-8AF
Country
United Kingdom
Facility Name
Wareneford Hospital
City
Oxford
ZIP/Postal Code
OX3 7JX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28433500
Citation
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.
Results Reference
derived
PubMed Identifier
28117049
Citation
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.
Results Reference
derived

Learn more about this trial

A Study of RO4917838 in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia (NN25310)

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