At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 249 enrolled
Drug / intervention
armodafinil +1 moredrug
Likely dose
armodafinil 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating armodafinil and placebo for Sleep Disorders and 3 related conditions. Completed, enrolled 249 participants across 62 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2007
Enrollment StartOct 2007
Primary CompletionMar 2009
TodayJul 2026
First PostedAug 21, 2007
Enrollment StartOct 1, 2007
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.9 years ago
Interventions
armodafinildrug
200 mg/day
placebodrug
placebo