NCT00772005

Study to Evaluate the Efficacy and Safety of Armodafinil as Adjunctive Therapy in Adults With Schizophrenia

A 24-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil (150, 200, and 250 mg/ Day) as Adjunctive Therapy in Adults With Schizophrenia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 287 (actual)
• Sponsor: Cephalon · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate whether armodafinil treatment is more effective than placebo as adjunctive therapy to antipsychotic medication in alleviating the negative symptoms of schizophrenia

Detailed description

This study was designed and was powered to evaluate the efficacy and safety of armodafinil treatment at dosages of 150, 200, and 250 mg/day compared with placebo over 24 weeks as an adjunctive therapy to antipsychotic medication (olanzapine, oral risperidone, or paliperidone) in adults with schizophrenia who were clinically stable at study entry. Specifically, the effects of armodafinil treatment on the negative symptoms of schizophrenia were the primary assessment in this study.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	armodafinil	150 mg/day armodafinil
DRUG	placebo	placebo
DRUG	armodafinil	200 mg/day armodafinil
DRUG	armodafinil	250 mg/day armodafinil

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-03-01
• Completion: 2010-05-01
• First posted: 2008-10-15
• Last updated: 2012-07-27
• Results posted: 2012-07-27

Locations

39 sites across 1 country: United States