A Phase 2 interventional study of RO4917838 and RO4917838 in Schizophrenia, sponsored by Hoffmann-La Roche. Completed at 73 sites in 10 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2014-06-24.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
This study will determine the efficacy and safety of RO4917838 in patients with schizophrenia who are stable on current antipsychotic treatment (olanzapine, que tiapine, risperidone, paliperidone or aripiprazole) with prominent negative or d isorganized thought symptoms. After a 4 week run in period on their current anti psychotic treatment, patients will be randomized to receive placebo 10mg, 30mg, or 60mg of RO4917838 once daily, p.o., as add-on therapy. The anticipated time o n study treatment is \<3 months, and the target sample size is 100-500 individual s.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 323 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: RO4917838 · Drug: Standard antipsychotic therapy
Drug: Placebo · Drug: Standard antipsychotic therapy
Drug: RO4917838 · Drug: Standard antipsychotic therapy
Drug: RO4917838 · Drug: Standard antipsychotic therapy
10mg po daily
30mg po daily
60mg po daily
po daily
As prescribed
Mean change from baseline in PANSS (Positive and Negative Syndrome Scale) negative factor score.
Time frame: Week 8
Change from baseline in total PANSS score, CGI, PSP, SGLS; cognition status changes.
Time frame: Throughout study
AEs, laboratory parameters, C-SSRS
Time frame: Throughout study
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hoffmann-La Roche