Clinical Trial Protocol Registry

Trial information

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

Status:
Recruiting
Protocol number:
NN25310
Sponsor:
Hoffmann-La Roche
Company division:
Pharmaceutical
Official Scientific 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.
Brief summary:
This multi-center, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 in patients with persistent, predominant negative symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks, followed by an optional treatment extension for up to 3 years. Target sample size is 630.
Study phase:
III
Study type:
Interventional; Treatment; Randomized; Parallel; Safety/efficacy study
Conditions:
  • Schizophrenia
Intervention type:
Drug
Intervention name:
RO4917838
Primary outcome:
  1. Efficacy (PANSS negative symptoms factor score) Time frame: Week 24
  2. Safety (incidence of adverse events) Time frame: Week 24
Inclusion criteria:
  • Adult patients, aged 18 years and above
  • Diagnosis of schizophrenia of paranoid, disorganized, residual, undifferentiated or catatonic subtype
  • Predominant negative symptoms
  • With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of two antipsychotics)
Exclusion criteria:
  • Evidence that patient has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder)
  • Body Mass Index (BMI) <18.5 or >40
  • 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 ESRS-A (Clinical Global Impression, Parkinsonism)
Gender:
Males or Females
Age limits:
Min: 18 years Max: N/A (No limit)
Accepts healthy volunteers:
No
Anticipated start date:
December, 2010
Trial registration date:
16.08.2010
Date last updated:
28.01.2013
This trial is being conducted at the following locations:
Argentina
  • BUENOS AIRES
  • CABA
  • CIUDAD AUTONOMA BS AS
  • CIUDAD DE MENDOZA
  • CORDOBA
  • LA PLATA
  • MENDOZA
  • ROSARIO
  • SANTIAGO DEL ESTERO
Australia
  • CLAYTON
  • FRANKSTON
  • MELBOURNE
  • WESTMEAD
Colombia
  • BARRANQUILLA
  • BELLO
  • BOGOTA
Finland
  • HELSINKI
  • KUOPIO
France
  • ANGOULEME
  • CAEN
  • CHATEAU GONTOR
  • CLERMONT-FERRAND
  • DOLE
  • ELANCOURT
  • HENIN-BEAUMONT
  • MARSEILLE
  • STRASBOURG
  • TOULON
Hungary
  • BALASSAGYARMAT
  • BUDAPEST
  • GYOR
  • GYULA
India
  • AHMEDABAD
  • BANGALORE
  • JAIPUR
  • KALYAN
  • LUCKNOW
  • MADURAI
  • MANGALORE
  • NASHIK
  • PUNE
  • RAIPUR
  • VADODARA
Mexico
  • MEXICO
  • MONTERREY
  • SAN LUIS POTOSI
Republic of Korea
  • BUSAN
  • GYEONGGI-DO
  • INCHEON
  • JEONJU
  • KWANGJU
  • SEOUL
Romania
  • ARAD
  • BUCURESTI
  • CLUJ-NAPOCA
  • LASI
  • ORADEA
  • SIBIU
  • TARGOUISTE
Russian Federation
  • KEMEROVO
  • LIPETSK
  • MOSCOW
  • MOSCOW REGION
  • NIZHNY NOVGOROD
  • SAINT PETERSBURG
  • SAMARA
  • SARTATOV
  • ST. PETERSBURG
  • ST PETERSBOURG
  • ST PETERSBURG
  • TALAGI
  • TOMSK
Sweden
  • LULEÅ
  • MALMÖ
  • STOCKHOLM
  • UPPSALA
U.S.A.
  • LITTLE ROCK, AR
  • ANAHEIM, CA
  • CERRITOS, CA
  • DOWNEY, CA
  • LONG BEACH, CA
  • PASADENA, CA
  • PICO RIVERA, CA
  • MIAMI, FL
  • MARIETTA, GA
  • IOWA CITY, IA
  • OAK BROOK, IL
  • GLEN BURNIE, MD
  • ST LOUIS, MO
  • RALEIGH, NC
  • TOMS RIVER, NJ
  • WILLINGBORO, NJ
  • ALBUQUERQUE, NM
  • BROOKLYN, NY
  • FRESH MEADOWS, NY
  • CINCINNATI, OH
  • PHILADELPHIA, PA
  • DALLAS, TX
  • HOUSTON, TX
  • THE WOODLANDS, TX
  • BOTHELL, WA
  • KIRKLAND, WA
United Kingdom
  • EDINBURGH
  • HULL
  • LONDON
  • OXFORD
  • SWANSEA

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