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

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.

Inclusion Criteria:

• Current diagnosis of obstructive sleep apnea/hypopnea syndrome (OSAHS)
• Complaint of residual excessive sleepiness despite nasal continuous positive airway pressure (nCPAP) therapy being effective
• Current or prior diagnosis of major depressive disorder or dysthymic disorder
• Clinically stable with regard to depressed mood and has shown a treatment response to selective serotonin reuptake inhibitor (SSRI) therapy or serotonin and norepinephrine reuptake inhibitor (SNRI) therapy
• Patient has been on a stable monotherapy dose of an allowed SSRI or SNRI for at least 8 weeks at the time of screening
• Women of childbearing potential must use a medically accepted method of contraception.

Exclusion Criteria:

• Confirmed or suspected diagnosis of a currently active sleep disorder other than obstructive sleep apnea/hypopnea syndrome (OSAHS)
• Current episode of major depression that is considered to be treatment-resistant
• A primary diagnosis of: eating disorder, psychotic disorder, delirium, dementia, substance-related disorders, or moderate to severe hypochondriasis
• Patient has a history of bipolar disorder, psychotic depression, schizophrenia, schizoaffective disorder, any other psychotic disorder, or other clinically significant uncontrolled psychiatric condition.
• Patient has a history of homicidal ideation or significant aggression
• Patient has a diagnosis of severe antisocial or borderline personality disorder
• Has a history of significant suicidal ideation, or has current active suicidal ideation, or is considered at imminent risk of self harm.
• Patient has a history consistent with fibromyalgia or chronic fatigue syndrome
• A high consumption of caffeinated products, approximately equivalent to 5 or more cups of coffee per day
• Patient history of any clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction
• Has a past or present seizure disorder
• Patient has a history of alcohol, narcotic, or any other substance abuse or dependence (with the exception of nicotine)
• Psychotherapeutic intervention for the patient was initiated within 8 weeks of the screening visit.
• Patient has known human immunodeficiency virus (HIV)
• Patient has any clinically significant uncontrolled medical condition (including illnesses related to the cardiovascular, renal, or hepatic systems) or surgical condition (treated or untreated)
• Patient is a pregnant or lactating woman
• Patient has previously received armodafinil; or, patient has used modafinil or any investigational product within 28 days of the baseline visit.