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

Completed · Phase 4 · Has a placebo group

Conditions studied: Sleep Disorders, Obstructive Sleep Apnea, Major Depressive Disorder, Dysthymic Disorder

In brief

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.

Key facts

Study ID

NCT00518986

Run by

Cephalon

People needed

249

Starts

2007-10-01

Expected to finish

2009-03-01

Last updated by the study team

2013-07-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pulmonary Associates, P.A. — Phoenix, Arizona, United States
• Psypharma Clinical Research — Phoenix, Arizona, United States
• PsyPharm Clinical Research, Inc. — Tucson, Arizona, United States
• Behavioral Research Specialists — Glendale, California, United States
• California Clinical Trials Medical Group, Inc. — Glendale, California, United States
• Pacific Sleep Medicine Services, Inc. — Redlands, California, United States
• Pacific Research Network, Inc. — San Diego, California, United States
• Pacific Sleep Medicine Services, Inc. — San Diego, California, United States
• California Clinical Trials Medical Group, Inc. — San Diego, California, United States
• SDS Clinical Research — Santa Ana, California, United States
• St. Johns Medical Plaza Sleep Disorders Center — Santa Monica, California, United States
• National Jewish Medical and Research Center — Denver, Colorado, United States
• Rocky Mountain Center for Clinical Research — Wheat Ridge, Colorado, United States
• PAB Clinical Research — Brandon, Florida, United States
• Florida Sleep Institute — Spring Hill, Florida, United States
• Clinical Research Group of St. Petersburg — St. Petersburg, Florida, United States
• SomnoMedics — Tampa, Florida, United States
• Stedman Clinical Trials, LLC — Tampa, Florida, United States
• Florida Pulmonary Research Center, LLC — Winter Park, Florida, United States
• The Sleep Disorders Center — Atlanta, Georgia, United States
• Neurotrials Research, Inc — Atlanta, Georgia, United States
• Sleep Disorders Center of Georgia — Atlanta, Georgia, United States
• SleepMed, Inc — Macon, Georgia, United States
• Chicago Research Center — Chicago, Illinois, United States
• Jasper Summit Research, LLC — Jasper, Alabama, United States

Full record on ClinicalTrials.gov

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