Trials / Completed
CompletedNCT00518986
Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Obstructive Sleep Apnea/Hypopnea and Depression
Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome With Major Depressive Disorder or Dysthymic Disorder
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 249 (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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | armodafinil | 200 mg/day |
| DRUG | placebo | placebo |
Timeline
- Start date
- 2007-10-01
- Primary completion
- 2009-03-01
- Completion
- 2009-03-01
- First posted
- 2007-08-21
- Last updated
- 2013-07-19
- Results posted
- 2011-03-29
Locations
62 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00518986. Inclusion in this directory is not an endorsement.