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

NCT01192867 | Completed Phase 3

• 2 other identifiers: NN253102010-020370-42
• Study Type: interventional
• Target: 629
• Locations: 14 countries
• Sites: 122

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (27)

• 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

Study Arms (3)

RO4917838 20 milligrams (mg)

EXPERIMENTAL

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.

Drug: RO4917838; Drug: Antipshychotics (Standard of Care)

RO4917838 10 mg

EXPERIMENTAL

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.

Drug: RO4917838; Drug: Antipshychotics (Standard of Care)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: Antipshychotics (Standard of Care)

Interventions

Placebo DRUG

Placebo will be administered orally QD for 56 weeks

Placebo

RO4917838 DRUG

RO4917838 will be administered orally at 20 or 10 mg QD for 56 weeks.

RO4917838 10 mg; RO4917838 20 milligrams (mg)

Antipshychotics (Standard of Care) DRUG

Participants will continue to receive their stable antipshychotic as standard of care based on their prescription up to Week 56.

Placebo; RO4917838 10 mg; RO4917838 20 milligrams (mg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (122)

K&S Professional Research Services LLC

Little Rock, Arkansas, 72201, United States

Location

Advanced Research Center Inc.

Anaheim, California, 92805, United States

Location

Comprehensive Clinical Development- Cerritos CA

Cerritos, California, 90703, United States

Location

Diligent Clinical Trials Inc

Downey, California, 90241, United States

Location

Care Research Center

La Palma, California, 90623, United States

Location

Pasadena Research Institute

Pasadena, California, 91106, United States

Location

CNRI - Los Angeles, LLC

Pico Rivera, California, 90660, United States

Location

Pharmax Research Clinic Inc.

Miami, Florida, 33126, United States

Location

Northwest Behavioral Research Center

Marietta, Georgia, 30060, United States

Location

American Medical Research, Inc

Oak Brook, Illinois, 60523, United States

Location

University of Iowa College of Medicine; Psychiatry Research

Iowa City, Iowa, 52242, United States

Location

Clinical Insights, Inc.

Glen Burnie, Maryland, 21061, United States

Location

St Louis Clinical Trials

St Louis, Missouri, 63141, United States

Location

Ocean Rheumatology

Toms River, New Jersey, 08775, United States

Location

CRI Worldwide LLC

Willingboro, New Jersey, 08046, United States

Location

Raymond G. Murphy VA Medical Center

Albuquerque, New Mexico, 87108, United States

Location

Behavioral Medical Research of Brooklyn

Brooklyn, New York, 11201, United States

Location

Comprehensive NeuroScience

Fresh Meadows, New York, 11366, United States

Location

North Carolina Psychiatric Research Center

Raleigh, North Carolina, 27603, United States

Location

UC Health Clinical Trials Office

Cincinnati, Ohio, 45267, United States

Location

Belmont Center for Comprehensive Treatment; Research

Philadelphia, Pennsylvania, 19131, United States

Location

Claghorn-Lesem Research Clinic, Inc.

Bellaire, Texas, 77401, United States

Location

FutureSearch Clinical Trials, LP

Dallas, Texas, 75231, United States

Location

Pillar Clinical Research LLC

Dallas, Texas, 75243, United States

Location

Family Psychiatry of the Woodlands P.A.

The Woodlands, Texas, 77381, United States

Location

Pacific Institute of Medical Sciences

Bothell, Washington, 98011, United States

Location

Eastside Therapeutic Resource

Kirkland, Washington, 98033, United States

Location

Centro SERES

Buenos Aires, 1425, Argentina

Location

Fundacion para el Estudio y Tratamiento des las Enfi Mentales

Buenos Aires, C1425AHQ, Argentina

Location

Mulieris

CABA, C1022AAO, Argentina

Location

Facene Fund.Argentina Contra Enferm.Neur.Del Envejecimiento

Ciudad Autonoma Bs As, 1117, Argentina

Location

Instituto Nacional de Psicopatologia

Ciudad Autonoma Bs As, 1405, Argentina

Location

Instituto DAMIC - Fundación Rusculleda

Córdoba, 5003, Argentina

Location

Sanatorio Prof.Leon.S.Morra S.A

Córdoba, X5009BIN, Argentina

Location

Instituto de Neurociencias San Agustín S.A.

La Plata, 1900, Argentina

Location

Centro de Psiquiatria Biologica Professor Julio J. Herrera; Psiquiatria

Mendoza, 5500, Argentina

Location

Resolution Psicopharmacology Research Institute

Mendoza, 5500, Argentina

Location

Centro de Asistencia e Investigación en Neurociencias

Mendoza, Argentina

Location

CIAP - Centro de Investigacion y Asistencia en Psiquiatria

Rosario, S2000QJI, Argentina

Location

Centro de Investigacion Clinica Farmacologica en Psiquiatria

Santiago del Estero, 4200, Argentina

Location

Westmead Hospital; Department of Psychiatry

Westmead, New South Wales, 2145, Australia

Location

Monash Medical Centre-Clayton Campus; School of Psychology and Psychiatry

Clayton, Victoria, 3168, Australia

Location

Frankston Hospital; Mental Health Service

Frankston, Victoria, 3199, Australia

Location

The Alfred Hospital; Monash Alfred Psychiatry Research Centre (MAP-RC)

Melbourne, Victoria, 3004, Australia

Location

Centro de Investigaciones y Proyectos en Neurociencias CIPNA

Barranquilla, Colombia

Location

E.S.E. Hospital Mental de Antioquia

Bello, Colombia

Location

Centro de Investigaciones del Sistema Nervioso Limitada - Gr

Bogotá, Colombia

Location

Privater

Kuopio, 70100, Finland

Location

Centre Hospitalier Universitaire Caen; Pôle Psychiatrie - Addictologie

Caen, 14033, France

Location

CHU Gabriel Montpied; Service de Psychiatrie

Clermont-Ferrand, 63000, France

Location

Centre Hospitalier Specialise du Jura

Dole, 39100, France

Location

Cabinet Médical Ambroise Paré

Élancourt, 78990, France

Location

Hôpital de la Conception; Pôle Psychiatrique Centre

Marseille, 13005, France

Location

CHU Strasbourg Nouvel Hôpital Civil;Service de Psychiatrie I

Strasbourg, 67091, France

Location

Hopital Chalucet; Unite de Psychiatrie

Toulon, 83000, France

Location

Dr. Kenessey Albert Hospital; Psychiatry I.

Balassagyarmat, 2660, Hungary

Location

Fov.Onk.Szt Janos Korh. E-Budai Egyesitett Korhazai; Pszichiatriaci rehabilitacio

Budapest, 1032, Hungary

Location

Semmelweis Egyetem AOK; Pszichiatriai es Pszichoterapias Klinika

Budapest, 1082, Hungary

Location

Fovarosi Onkormanyzat Nyiro Gyula Korhaza; Pszichatria II

Budapest, 1135, Hungary

Location

Fovarosi Onkormanyzat Nyiro Gyula Korhaza; Pszichiatria I.

Budapest, 1135, Hungary

Location

UNO Medical Trials Kft.

Budapest, 1135, Hungary

Location

Petz Aladar Megyei Oktato Korhaz; Pszichiatria I.

Győr, 9024, Hungary

Location

Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek

Gyula, 5703, Hungary

Location

Samvedna Hospitals; Samvedana Psychiatry and Sex Therapy Hospital

Ahmedabad, 380006, India

Location

Sneh Clinic

Ahmedabad, 380008, India

Location

Gujarat Institute of Psychological Research (GIPS)

Ahmedabad, 380015, India

Location

Mental Health Care & Research

Jaipur, 302017, India

Location

R. K.Yadav Memorial Mental Health & De-Addiction Hospital

Jaipur, 302021, India

Location

Manav Neuropsychiatric Hospital Pvt. Ltd.

Kalyān, 421301, India

Location

Kasturba Medical College & Hospital

Mangalore, 575001, India

Location

K. S. Hegde Medical Academy

Mangalore, 575018, India

Location

Poona Hospital and Research Centre

Pune, 411030, India

Location

Brij Psychiatry Hospital & Muskaan Research Centre; Maanav Health Foundation

Vadodara, 390001, India

Location

Arete Proycectos y Administracion S.C

México, 05300, Mexico

Location

Centro de Investigacion Medica S.C; Hospital Santa Cecilia de Monterrey S.A. de C.V.

Monterrey, 64000, Mexico

Location

Medikalink

Monterrey, 64060, Mexico

Location

Instituto de informacion e investigacion en salud mental AC

Monterrey, 64710, Mexico

Location

Hospital Lomas de San Luis Internacional

San Luis Potosí City, 72818, Mexico

Location

Spitalul Clinic Judetean Arad; Departamentul de Psihiatrie

Arad, 310022, Romania

Location

Spit Univ Urgenta Militar Dr. Carol Davila; Sectia Psihiatrie

Bucharest, 010825, Romania

Location

Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Clinical III Psihiatrie

Bucharest, 041914, Romania

Location

Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Comunitara si Reintegrare Psihosociala

Bucharest, 041914, Romania

Location

Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Sectia Clinica XIII Psihiatrie

Bucharest, 041914, Romania

Location

Spitalul Clinic Judetean de Urgenta Cluj; Sectia Clinica de Psihiatrie III

Cluj-Napoca, 400012, Romania

Location

Spitalul Universitar de Psihiatrie Socola

Lasi, 700282, Romania

Location

Spitalul Clinic Municipal Dr. Gavril Curteanu; Sectia Clinica Psihiatrie I

Oradea, 410154, Romania

Location

Spitalul de Psihiatrie Dr. Gh. Preda Sibiu;CSM Adulti Sibiu

Sibiu, 550082, Romania

Location

Cabinet Medical S.C. Lorentina 2102 S.R.L.; Psihiatrie

Targouiste, 130081, Romania

Location

Kemerovo Regional Clinical Psychiatric Hospital

Kemerovo, 650036, Russia

Location

GUZ Lipetsk Regional psychoneurological Hospital #1; Dispansary Department

Lipetsk, 399313, Russia

Location

Scientifically Research Institute of Psychiatry of Ministry of Health of the Russian Federation

Moscow, 107076, Russia

Location

Institution of RAMS (Mental Health Research Center of RAMS)

Moscow, 115522, Russia

Location

Federal State Institution Moscow SRI of Psychiatry of Minzdravsocrazvitia

Moscow, 117995, Russia

Location

Central Moscow Regional Clinical Psychiatric Hospital

Moscow, 127083, Russia

Location

Moscow Region Psychiatric Hospital #5

Moscow Region, 142601, Russia

Location

City Clinical Psychiatry Hospital #1

Nizhny Novgorod, 603155, Russia

Location

St. Petersburg State Healthcare Institution

Saint Petersburg, 190005, Russia

Location

City Psychiatric Hospital #2 of St. Nikolay Chudotvorets

Saint Petersburg, 190121, Russia

Location

Saint Petersburg Psychoneurological Research Institute of Roszdrav n.a. Bekhterev

Saint Petersburg, 192019, Russia

Location

St. Petersburg GUZ City Psychiatric Hospital #6

Saint Petersburg, 193167, Russia

Location

Military Medical Academy

Saint Petersburg, 194044, Russia

Location

St. Petersburg State Healthcare Institution "City Mental Hospital #3; I.I. Skvortsov-Stepanov

Saint Petersburg, 197341, Russia

Location

Samara Psychiatric Hospital

Samara, 443016, Russia

Location

Mhi City Clinical Hospital #2 Named After v.i. Razumousky

Sartatov, 410028, Russia

Location

Arkhangelsk Regional Clinical Psychiatric Hospital

Talagi, 163530, Russia

Location

Tomsk Clinical Psychiatric Hospital

Tomsk, 634014, Russia

Location

Inje University Busan Paik Hospital

Busan, 47392, South Korea

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Korea University Ansan Hospital

Gyeonggi-do, 15355, South Korea

Location

Inha University Hospital

Incheon, 22332, South Korea

Location

Gil Hospital. Gachon University

Incheon, 405-760, South Korea

Location

Chonbuk National Uni Hospital

Jeollabuk-do, 561-712, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

The Catholic University of Korea St.Mary's Hospital

Seoul, 150-713, South Korea

Location

Integrerad Närsjukvård i Malmö

Malmo, 21135, Sweden

Location

Karolinska Universitetssjukhuset Huddinge, Psykiatri Sydväst

Stockholm, 14186, Sweden

Location

Danderyds Sjukhus AB; PRIMA Vuxenpsykiatri

Stockholm, 18288, Sweden

Location

Akademiska Sjukhuset; Psykosvård och rättspsykiatrisk vård

Uppsala, 75185, Sweden

Location

Royal Edinburgh Hospital; Psychiatry

Edinburgh, EH10 5HF, United Kingdom

Location

Institute of Pyschiatry

London, SE5-8AF, United Kingdom

Location

Wareneford Hospital

Oxford, OX3 7JX, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 28433500 DERIVED

• 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.

  PMID: 28117049 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: September 1, 2010
• Study Start: December 11, 2010
• Primary Completion: May 26, 2014
• Study Completion: May 26, 2014
• Last Updated: June 26, 2017

Record last verified: 2017-06

Locations

CO (3); FI (1); RO (10); IN (10); ME (5); US (27); RU (18); GB (3); HU (8); AU (4); KR (9); SE (4); AR (13); FR (7)