drugset / Trial / NCT00518986

Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Obstructive Sleep Apnea/Hypopnea and Depression

NCT00518986

Phase 4 Completed 249 enrolled Cephalon
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of the study is to evaluate whether armodafinil at a target dosage of 200 mg/day is more effective than placebo treatment in improving excessive sleepiness in patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) who have comorbid major depressive disorder or dysthymic disorder.

Timeline

Start
2007-10
Primary completion
2009-03
Completion
2009-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Armodafinil Small molecule 200 mg