A Study of RO4917838 in Participants With Persistent, Predominant Negative Symptoms of Schizophrenia (NN25310)
Completed · Phase 3 · Has a placebo group
Conditions studied: Schizophrenia
In brief
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.
Key facts
- Study ID
- NCT01192867
- Run by
- Hoffmann-La Roche
- People needed
- 629
- Starts
- 2010-12-11
- Expected to finish
- 2014-05-26
- Last updated by the study team
- 2017-06-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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)
Where it is running
- Advanced Research Center Inc. — Anaheim, California, United States
- Comprehensive Clinical Development- Cerritos CA — Cerritos, California, United States
- Diligent Clinical Trials Inc — Downey, California, United States
- Care Research Center — La Palma, California, United States
- Pasadena Research Institute — Pasadena, California, United States
- CNRI - Los Angeles, LLC — Pico Rivera, California, United States
- Pharmax Research Clinic Inc. — Miami, Florida, United States
- Northwest Behavioral Research Center — Marietta, Georgia, United States
- American Medical Research, Inc — Oak Brook, Illinois, United States
- University of Iowa College of Medicine; Psychiatry Research — Iowa City, Iowa, United States
- Clinical Insights, Inc. — Glen Burnie, Maryland, United States
- St Louis Clinical Trials — St Louis, Missouri, United States
- Ocean Rheumatology — Toms River, New Jersey, United States
- CRI Worldwide LLC — Willingboro, New Jersey, United States
- Raymond G. Murphy VA Medical Center — Albuquerque, New Mexico, United States
- Behavioral Medical Research of Brooklyn — Brooklyn, New York, United States
- Comprehensive NeuroScience — Fresh Meadows, New York, United States
- North Carolina Psychiatric Research Center — Raleigh, North Carolina, United States
- UC Health Clinical Trials Office — Cincinnati, Ohio, United States
- Belmont Center for Comprehensive Treatment; Research — Philadelphia, Pennsylvania, United States
- Claghorn-Lesem Research Clinic, Inc. — Bellaire, Texas, United States
- FutureSearch Clinical Trials, LP — Dallas, Texas, United States
- Pillar Clinical Research LLC — Dallas, Texas, United States
- Family Psychiatry of the Woodlands P.A. — The Woodlands, Texas, United States
- K&S Professional Research Services LLC — Little Rock, Arkansas, United States
Full record on ClinicalTrials.gov
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