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

Cephalon

Status and phase

Completed

Phase 4

Conditions

Sleep Disorders

Major Depressive Disorder

Dysthymic Disorder

Obstructive Sleep Apnea

Treatments

Drug: placebo

Drug: armodafinil

Study type

Interventional

Funder types

Industry

Identifiers

NCT00518986

C10953/4024/ES/US

Details and patient eligibility

About

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.

Enrollment

249 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.