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

NCT01116830 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2016-11-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Placebo

Orally daily for 6 weeks

DRUG

RO4917838

10 mg daily orally for 6 weeks

DRUG

Standard Antipsychotic Therapy

Participants will continue to receive their current antipsychotic treatment (as they are receiving at the time of screening). Protocol does not specify any particular standard antipsychotic therapy.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01116830 on ClinicalTrials.gov