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.
Inclusion Criteria:
- Current diagnosis of 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
- Patient has been on a stable monotherapy dose of an allowed SSRI 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
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.
- Patients with a score of 2 on any of the insomnia items (items 4, 5, or 6) of the
HAMD-17 are to be excluded.
Jasper Summit Research, LLC, Jasper, Alabama 35501, United States; Recruiting
Site Contact
Janice Westerman, MD, Principal Investigator
Pulmonary Associates, P.A., Phoenix, Arizona 85012, United States; Recruiting
Site Contact
Mark Gotfried, MD, Principal Investigator
PsyPharm Clinical Research, Inc., Tucson, Arizona 85712, United States; Recruiting
Site Contact
Derek Loewy, PhD, Principal Investigator
Psypharma Clinical Research, Phoenix, Arizona 85050, United States; Recruiting
Site Contact
Barbara Harris, PhD, Principal Investigator
California Clinical Trials Medical Group, Inc., Glendale, California 91206, United States; Completed
Pacific Sleep Medicine Services, Inc., San Diego, California 92121, United States; Recruiting
Site Contact
Milton Erman, MD, Principal Investigator
California Clinical Trials Medical Group, Inc., San Diego, California 92123, United States; Completed
St. Johns Medical Plaza Sleep Disorders Center, Santa Monica, California 90404, United States; Recruiting
Site Contact
Paul Haberman, MD, Principal Investigator
Pacific Sleep Medicine Services, Inc., Redlands, California 92373, United States; Recruiting
Site Contact
Stuart Menn, MD, Principal Investigator
SDS Clinical Research, Santa Ana, California 92704, United States; Recruiting
Site Contact
Julie Thompson-Dobkin, DO, Principal Investigator
Pacific Research Network, Inc., San Diego, California 92103, United States; Recruiting
Site Contact
Stephen Thein, PhD, Principal Investigator
Behavioral Research Specialists, Glendale, California 91204, United States; Recruiting
Site Contact
Jesse Carr, MD, Principal Investigator
National Jewish Medical and Research Center, Denver, Colorado 80206, United States; Completed
Rocky Mountain Center for Clinical Research, Wheat Ridge, Colorado 80033, United States; Recruiting
Site Contact
Robert Lapidus, MD, Principal Investigator
PAB Clinical Research, Brandon, Florida 33511, United States; Recruiting
Site Contact
Daniel Lorch, MD, Principal Investigator
Clinical Research Group of St. Petersburg, St. Petersburg, Florida 33707, United States; Completed
Florida Sleep Institute, Spring Hill, Florida 34609, United States; Recruiting
Site Contact
William Kohler, MD, Principal Investigator
Stedman Clinical Trials, LLC, Tampa, Florida 33613, United States; Recruiting
Site Contact
Mary Stedman, MD, Principal Investigator
Florida Pulmonary Research Center, LLC, Winter Park, Florida 33613, United States; Recruiting
Site Contact
Faisal Fakih, MD, Principal Investigator
SomnoMedics, Tampa, Florida 33607, United States; Recruiting
Site Contact
Alberto Pineiro, MD, Principal Investigator
Sleep Disorders Center of Georgia, Atlanta, Georgia 30342, United States; Recruiting
Site Contact
Alan Lankford, PhD, Principal Investigator
SleepMed, Inc, Macon, Georgia 31201, United States; Recruiting
Site Contact
Charles Wells, MD, Principal Investigator
The Sleep Disorders Center, Atlanta, Georgia 30339, United States; Recruiting
Site Contact
Scott Leibowitz, MD, Principal Investigator
Neurotrials Research, Inc, Atlanta, Georgia 30342, United States; Recruiting
Site Contact
Russell Rosenberg, PhD, Principal Investigator
Peoria Pulmonary Associates, Peoria, Illinois 61603, United States; Recruiting
Site Contact
Patrick Whitten, MD, Principal Investigator
Sleep and Behavior Medicine, Vernon Hills, Illinois 60061, United States; Recruiting
Site Contact
Alexander Golbin, MD, Principal Investigator
Chicago Research Center, Chicago, Illinois 60634, United States; Recruiting
Site Contact
Jane Dyonzak, PhD, Principal Investigator
The Center for Sleep and Wake Disorders, Danville, Indiana 46122, United States; Recruiting
Site Contact
James Cook, MD, Principal Investigator
Vince & Associates Clinical Research, Overland Park, Kansas 66212, United States; Recruiting
Steven Hull, MD, Principal Investigator
Graves Gilbert Clinic, Bowling Green, Kentucky 42101, United States; Recruiting
Site Contact
James Hansbrough, MD, Principal Investigator
Community Research, Crestview, Kentucky 45217, United States; Recruiting
Site Contact
David Mayleben, PhD, Principal Investigator
Clinical Trials of America, Shreveport, Louisiana 71101, United States; Recruiting
Site Contact
Susan Kemp, MD, Principal Investigator
The Center for Sleep & Wake Disorders, Chevy Chase, Maryland 20815, United States; Recruiting
Site Contact
Helene Emsellem, MD, Principal Investigator
Sleep Health Centers, Brighton, Massachusetts 02135, United States; Recruiting
Site Contact
Cynthia Dorsey, PhD, Principal Investigator
AccelRx Research, Fall River, Massachusetts 02721, United States; Recruiting
Site Contact
L. R. Pet, MD, Principal Investigator
The Center for Sleep Medicine, Hattiesburg, Mississippi 39406, United States; Recruiting
Site Contact
John Harsh, PhD, Principal Investigator
Washington University, St. Louis, Missouri 63108, United States; Recruiting
Site Contact
Stephen Duntley, MD, Principal Investigator
Somnos Sleep Center, Lincoln, Nebraska 68510, United States; Recruiting
Site Contact
John Trapp, MD, Principal Investigator
Clinilabs, Inc, New York City, New York 10019, United States; Recruiting
Site Contact
Jonathan Sacker-Bernstein, MD, Principal Investigator
Brooklyn Medical Institute, Brooklyn, New York 11223, United States; Recruiting
Site Contact
Zinoviy Benzar, MD, PhD, Principal Investigator
Sleep Medicine Centers, West Seneca, New York 14224, United States; Recruiting
Site Contact
Daniel Rifkin, MD, Principal Investigator
Duke University Medical Center, Durham, North Carolina 27710, United States; Recruiting
Site Contact
Andrew Krystal, MD, Principal Investigator
Clinical Trials of America, Hickory, North Carolina 28601, United States; Recruiting
Site Contact
Michael DeSantis, MD, Principal Investigator
Tri-State Sleep Disorders Center, Cincinnati, Ohio 45246, United States; Recruiting
Site Contact
Martin Scharf, PhD, Principal Investigator
Ohio Sleep Medicine Institute, Dublin, Ohio 43017, United States; Recruiting
Site Contact
Markus Schmidt, MD, PhD, Principal Investigator
North Star Medical Research, LLC, Middleburg Heights, Ohio 44130, United States; Recruiting
Site Contact
Mark Woyshville, MD, Principal Investigator
Lynn Health Science Institute, Oklahoma City, Oklahoma 73112, United States; Recruiting
Site Contact
William Orr, PhD, Principal Investigator
University of Pennsylvania Center for Sleep, Philadelphia, Pennsylvania 19104, United States; Completed
CRI Worldwide, Philadelphia, Pennsylvania 19139, United States; Recruiting
Site Contact
Daniel Gruener, MD, Principal Investigator
University Services, West Chester, Pennsylvania 19380, United States; Recruiting
Site Contact
Mark Burton, DO, Principal Investigator
Sleep Lab of Northeastern PA, Clarks Summit, Pennsylvania 18411, United States; Recruiting
Site Contact
Ashokkumar Patel, MD, Principal Investigator
AccelRx Research, Lincoln, Rhode Island 02865, United States; Recruiting
Site Contact
James Whalen, MD, Principal Investigator
SleepMed of South Carolina, Columbia, South Carolina 29201, United States; Recruiting
Site Contact
Richard Bogan, MD, Principal Investigator
Lowcountry Lung and Critical Care, Charleston, South Carolina 29406, United States; Recruiting
Site Contact
Thomas Kaelin, DO, Principal Investigator
Sleep Medicine of Middle Tennessee, Nashville, Tennessee 37203, United States; Completed
Baylor College of Medicine VAMC Sleep Research, Houston, Texas 77030, United States; Recruiting
Site Contact
Max Hirshkowitz, PhD, Principal Investigator
Sleep Medicine Associates of Texas, P.A., Dallas, Texas 75231, United States; Recruiting
Site Contact
Andrew Jamieson, MD, Principal Investigator
FutureSearch Trials of Neurology, Austin, Texas 78756, United States; Recruiting
Site Contact
John Hudson, MD, Principal Investigator
Houston Sleep Center, Houston, Texas 77063, United States; Recruiting
Site Contact
Todd Swick, MD, Principal Investigator
Northwest Clinical Research, Bellevue, Washington 98004, United States; Completed
Pacific Sleep Medicine Services, Inc., Seattle, Washington 98122, United States; Recruiting
Site Contact
Ralph Pascualy, MD, Principal Investigator
