efficacy and safety of armodafinil for adults with excessive sleepiness obstructive sleep apnea/hypopnea and depression

Conditions: Sleep Disorders; Obstructive Sleep Apnea; Major Depressive Disorder; Dysthymic Disorder

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.


Eligibility criteria:
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.

Keywords: obstructive sleep apnea/hypopnea syndrome excessive sleepiness