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

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Antipsychotic Agents

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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