A Study of the Effect of RO4917838 on Biomarker Measures of Cognitive Dysfunction in Participants With Schizophrenia and Schizoaffective Disorder

Completed · Phase 1 · Has a placebo group

Conditions studied: Schizophrenia

In brief

This randomized, double-blind, placebo-controlled parallel group study will assess the effect on biomarkers measures of cognitive dysfunction, the clinical efficacy and safety of RO4917838 in participants with schizophrenia and schizoaffective disorder. Participants will be randomized to receive either RO4917838 (10 milligrams \[mg\] daily orally) or placebo for 6 weeks, in addition to their stable antipsychotic medication. Anticipated time on study treatment is 6 weeks.

Key facts

Study ID

NCT01116830

Run by

Hoffmann-La Roche

People needed

29

Starts

2010-11-01

Expected to finish

2014-02-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of schizophrenia or schizoaffective disorder (based on screening tests)
• Medically stable for 1 month and psychiatrically stable without symptom exacerbation for 6 weeks prior to baseline
• On stable treatment with a maximum of 2 antipsychotics

You may not qualify if…

• Change in regimen for any psychotropic or sleep medication within 1 month
• Treatment with more than (>) 1 mood stabilizer or antidepressant
• Use of clozapine within 2 months
• Bipolar disorder, or more than mild anxiety disorder

Where it is running

• Study site — Orangeburg, New York, United States

Full record on ClinicalTrials.gov

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