Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Obstructive Sleep Apnea/Hypopnea and Depression
Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome With Major Depressive Disorder or Dysthymic Disorder
1 other identifier
interventional
249
1 country
62
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2007
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2007
CompletedFirst Posted
Study publicly available on registry
August 21, 2007
CompletedStudy Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
March 29, 2011
CompletedJuly 19, 2013
July 1, 2013
1.4 years
August 17, 2007
March 30, 2010
July 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline on Maintenance of Wakefulness Test (MWT) to Endpoint (12 Weeks or Last Observation After Baseline)
MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of 4 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occurred. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to Endpoint (12 weeks or last observation after baseline) in mean sleep latency averaged from the 4 intervals was measured. Poorest outcome was 0 minutes the best was 30 minutes.
Baseline and 12 weeks (or last observation after baseline)
Clinical Global Impression of Change (CGI-C) at Endpoint (12-weeks or Last Observation After Baseline)
The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates improvement by 7 categories: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories of illness as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least "minimally improved" in CGI-C ratings (as related to sleepiness) were assessed.
12 weeks (or last observation after baseline)
Secondary Outcomes (58)
Change From Baseline on the Epworth Sleepiness Scale (ESS) at Endpoint (12 Weeks or Last Measurement After Baseline)
Baseline and 12 weeks (or last observation after baseline)
Change From Baseline on Maintenance of Wakefulness Test (MWT) at 4 Weeks
baseline and 4 weeks
Change From Baseline on Maintenance of Wakefulness Test (MWT) at 8 Weeks
Baseline and 8 weeks following start of study drug administration
Change From Baseline on Maintenance of Wakefulness Test (MWT) at 12 Weeks
baseline and 12 weeks (or last observation after baseline)
Clinical Global Impression of Change (CGI-C) at 4 Weeks
4 weeks after beginning study drug treatment
- +53 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORarmodafinil 200 mg/day
2
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
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)
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cephalonlead
Study Sites (62)
Jasper Summit Research, LLC
Jasper, Alabama, 35501, United States
Pulmonary Associates, P.A.
Phoenix, Arizona, 85012, United States
Psypharma Clinical Research
Phoenix, Arizona, 85050, United States
PsyPharm Clinical Research, Inc.
Tucson, Arizona, 85712, United States
Behavioral Research Specialists
Glendale, California, 91204, United States
California Clinical Trials Medical Group, Inc.
Glendale, California, 91206, United States
Pacific Sleep Medicine Services, Inc.
Redlands, California, 92373, United States
Pacific Research Network, Inc.
San Diego, California, 92103, United States
Pacific Sleep Medicine Services, Inc.
San Diego, California, 92121, United States
California Clinical Trials Medical Group, Inc.
San Diego, California, 92123, United States
SDS Clinical Research
Santa Ana, California, 92704, United States
St. Johns Medical Plaza Sleep Disorders Center
Santa Monica, California, 90404, United States
National Jewish Medical and Research Center
Denver, Colorado, 80206, United States
Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado, 80033, United States
PAB Clinical Research
Brandon, Florida, 33511, United States
Florida Sleep Institute
Spring Hill, Florida, 34609, United States
Clinical Research Group of St. Petersburg
St. Petersburg, Florida, 33707, United States
SomnoMedics
Tampa, Florida, 33607, United States
Stedman Clinical Trials, LLC
Tampa, Florida, 33613, United States
Florida Pulmonary Research Center, LLC
Winter Park, Florida, 33613, United States
The Sleep Disorders Center
Atlanta, Georgia, 30339, United States
Neurotrials Research, Inc
Atlanta, Georgia, 30342, United States
Sleep Disorders Center of Georgia
Atlanta, Georgia, 30342, United States
SleepMed, Inc
Macon, Georgia, 31201, United States
Chicago Research Center
Chicago, Illinois, 60634, United States
Peoria Pulmonary Associates
Peoria, Illinois, 61603, United States
Sleep and Behavior Medicine
Vernon Hills, Illinois, 60061, United States
The Center for Sleep and Wake Disorders
Danville, Indiana, 46122, United States
Vince & Associates Clinical Research
Overland Park, Kansas, 66212, United States
Graves Gilbert Clinic
Bowling Green, Kentucky, 42101, United States
Community Research
Crestview, Kentucky, 45217, United States
Clinical Trials of America
Shreveport, Louisiana, 71101, United States
The Center for Sleep & Wake Disorders
Chevy Chase, Maryland, 20815, United States
Sleep Health Centers
Brighton, Massachusetts, 02135, United States
AccelRx Research
Fall River, Massachusetts, 02721, United States
The Center for Sleep Medicine
Hattiesburg, Mississippi, 39406, United States
Washington University
St Louis, Missouri, 63108, United States
Somnos Sleep Center
Lincoln, Nebraska, 68510, United States
Brooklyn Medical Institute
Brooklyn, New York, 11223, United States
Clinilabs, Inc
New York, New York, 10019, United States
Sleep Medicine Centers
West Seneca, New York, 14224, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Clinical Trials of America
Hickory, North Carolina, 28601, United States
Tri-State Sleep Disorders Center
Cincinnati, Ohio, 45246, United States
Ohio Sleep Medicine Institute
Dublin, Ohio, 43017, United States
North Star Medical Research, LLC
Middleburg Heights, Ohio, 44130, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, 43606, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Sleep Lab of Northeastern PA
Clarks Summit, Pennsylvania, 18411, United States
University of Pennsylvania Center for Sleep
Philadelphia, Pennsylvania, 19104, United States
CRI Worldwide
Philadelphia, Pennsylvania, 19139, United States
University Services
West Chester, Pennsylvania, 19380, United States
AccelRx Research
Lincoln, Rhode Island, 02865, United States
Lowcountry Lung and Critical Care
Charleston, South Carolina, 29406, United States
SleepMed of South Carolina
Columbia, South Carolina, 29201, United States
Sleep Medicine of Middle Tennessee
Nashville, Tennessee, 37203, United States
FutureSearch Trials of Neurology
Austin, Texas, 78756, United States
Sleep Medicine Associates of Texas, P.A.
Dallas, Texas, 75231, United States
Baylor College of Medicine VAMC Sleep Research
Houston, Texas, 77030, United States
Houston Sleep Center
Houston, Texas, 77063, United States
Northwest Clinical Research
Bellevue, Washington, 98004, United States
Pacific Sleep Medicine Services, Inc.
Seattle, Washington, 98122, United States
Related Publications (1)
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.
PMID: 20051221DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical monitor
- Organization
- Cephalon, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2007
First Posted
August 21, 2007
Study Start
October 1, 2007
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
July 19, 2013
Results First Posted
March 29, 2011
Record last verified: 2013-07