Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Obstructive Sleep Apnea/Hypopnea and Depression
NCT ID: NCT00518986
Last Updated: 2013-07-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
249 participants
INTERVENTIONAL
2007-10-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
armodafinil 200 mg/day
armodafinil
200 mg/day
2
Placebo
placebo
placebo
Interventions
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armodafinil
200 mg/day
placebo
placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Cephalon
INDUSTRY
Responsible Party
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Locations
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Jasper Summit Research, LLC
Jasper, Alabama, United States
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
Peoria Pulmonary Associates
Peoria, Illinois, United States
Sleep and Behavior Medicine
Vernon Hills, Illinois, United States
The Center for Sleep and Wake Disorders
Danville, Indiana, United States
Vince & Associates Clinical Research
Overland Park, Kansas, United States
Graves Gilbert Clinic
Bowling Green, Kentucky, United States
Community Research
Crestview, Kentucky, United States
Clinical Trials of America
Shreveport, Louisiana, United States
The Center for Sleep & Wake Disorders
Chevy Chase, Maryland, United States
Sleep Health Centers
Brighton, Massachusetts, United States
AccelRx Research
Fall River, Massachusetts, United States
The Center for Sleep Medicine
Hattiesburg, Mississippi, United States
Washington University
St Louis, Missouri, United States
Somnos Sleep Center
Lincoln, Nebraska, United States
Brooklyn Medical Institute
Brooklyn, New York, United States
Clinilabs, Inc
New York, New York, United States
Sleep Medicine Centers
West Seneca, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Clinical Trials of America
Hickory, North Carolina, United States
Tri-State Sleep Disorders Center
Cincinnati, Ohio, United States
Ohio Sleep Medicine Institute
Dublin, Ohio, United States
North Star Medical Research, LLC
Middleburg Heights, Ohio, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Sleep Lab of Northeastern PA
Clarks Summit, Pennsylvania, United States
University of Pennsylvania Center for Sleep
Philadelphia, Pennsylvania, United States
CRI Worldwide
Philadelphia, Pennsylvania, United States
University Services
West Chester, Pennsylvania, United States
AccelRx Research
Lincoln, Rhode Island, United States
Lowcountry Lung and Critical Care
Charleston, South Carolina, United States
SleepMed of South Carolina
Columbia, South Carolina, United States
Sleep Medicine of Middle Tennessee
Nashville, Tennessee, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
Sleep Medicine Associates of Texas, P.A.
Dallas, Texas, United States
Baylor College of Medicine VAMC Sleep Research
Houston, Texas, United States
Houston Sleep Center
Houston, Texas, United States
Northwest Clinical Research
Bellevue, Washington, United States
Pacific Sleep Medicine Services, Inc.
Seattle, Washington, United States
Countries
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References
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Krystal AD, Harsh JR, Yang R, Rippon GA, Lankford DA. A double-blind, placebo-controlled study of armodafinil for excessive sleepiness in patients with treated obstructive sleep apnea and comorbid depression. J Clin Psychiatry. 2010 Jan;71(1):32-40. doi: 10.4088/JCP.09m05536gry. Epub 2009 Dec 29.
Other Identifiers
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C10953/4024/ES/US
Identifier Type: -
Identifier Source: org_study_id
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