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A Study of RO4917838 in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia (NN25310)
- Psychiatric Disorder
- Schizophrenia
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Completed
This trial runs in
Cities
- Ahmedabad
- Albuquerque
- Anaheim
- Ansan-si
- Balassagyarmat
- Barranquilla
- Bogotá
- Bothell
- București
- Budapest
- Buenos Aires
- Busan
- Caen
- cerritos
- Cincinnati
- Clayton
- Clermont-Ferrand
- Cluj-Napoca
- Dallas
- darien
- DCE
- Dole
- Downey
- Frankston
- Gyula
- Győr
- Houston
- Incheon
- Iowa City
- Jaipur
- Kemerovo
- London
- Long Beach
- Mangaluru
- Marietta
- Marseille
- Melbourne
- Mendoza
- Miami
- Monterrey
- Moscow
- New York
- Nizhny Novgorod
- oradea
- Oxford
- Philadelphia
- Pico Rivera
- Pune
- Richardson
- Rosario
- Saint Petersburg
- Samara
- San Luis Potosí
- Sankt-Peterburg
- Saratov
- Seoul
- St. Louis
- Stockholm
- Strasbourg
- The Woodlands
- Toms River
- Toulon
- Uppsala län
- villa-elisa
- Westmead
Trial Identifier:
NCT01192867 2010-020370-42 NN25310
Trial 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.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT01192867, NN25310, 2010-020370-42
Trial Identifier
Placebo, RO4917838, Antipshychotics (Standard of Care)
Treatments
Schizophrenia
Condition
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
Eligibility Criteria
All
Gender
≥18 Years
Age
No
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)
For the latest version of this information please go to www.forpatients.roche.com