Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Obstructive Sleep Apnea/Hypopnea and Depression
Condition: Sleep Disorders; Obstructive Sleep Apnea; Major Depressive Disorder; Dysthymic Disorder
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Wake Disorders; Sleepiness; Depressive Disorder; Depression; Depressive Disorder, Major; Dysthymic Disorder
Intervention: armodafinil; placebo
Intervention description: 200 mg/day; placebo
Intervention MeSH terms: Modafinil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 249.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Obstructive Sleep Apnea/Hypopnea Syndrome; Excessive Sleepiness

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.