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



Status:Completed
Conditions:Cognitive Studies, Schizophrenia, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:6/3/2016
Start Date:November 2010
End Date:February 2014

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Trial Summary
Trial Overview
Inclusion Criteria

A Randomized, Double-blind, Placebo-controlled Parallel Arm Study of the Effect of RO4917838 on Biomarker Measures of Cognitive Dysfunction in Schizophrenia and Schizoaffective Disorder

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
RO4917383 in patients with schizophrenia and schizoaffective disorder. Patients will be
randomized to receive either RO4917383 (10mg daily orally) or placebo for 6 weeks, in
addition to their stable antipsychotic medication. Anticipated time on study treatment is 6
weeks.


Inclusion Criteria:

- adult patients, 18-65 years of age

- diagnosis of schizophrenia or schizoaffective disorder (based on screening tests)

- medically stable for 1 month and psychiatrically stable without symptom acerbation
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 >1 mood stabilizer or antidepressant

- use of clozapine within 2 months

- bipolar disorder, or more than mild anxiety disorder
We found this trial at
1
site
Clinical Trial Facility in Orangeburg New York
Orangeburg, New York 10962
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from
Orangeburg, NY
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