Clinical trial NCT00518986: Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Obstructive Sleep Apnea/Hypopnea and Depression
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep Disorders
Obstructive Sleep Apnea
Major Depressive Disorder
Dysthymic Disorder
Keywords: Obstructive Sleep Apnea/Hypopnea Syndrome
Excessive Sleepiness
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2007-08-21
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change From Baseline on Maintenance of Wakefulness Test (MWT) to Endpoint (12 Weeks or Last Observation After Baseline)
timeFrame: Baseline and 12 weeks (or last observation after baseline)
measure: Clinical Global Impression of Change (CGI-C) at Endpoint (12-weeks or Last Observation After Baseline)
timeFrame: 12 weeks (or last observation after baseline)
Secondary outcomes:
measure: Change From Baseline on the Epworth Sleepiness Scale (ESS) at Endpoint (12 Weeks or Last Measurement After Baseline)
timeFrame: Baseline and 12 weeks (or last observation after baseline)
measure: Change From Baseline on Maintenance of Wakefulness Test (MWT) at 4 Weeks
timeFrame: baseline and 4 weeks
measure: Change From Baseline on Maintenance of Wakefulness Test (MWT) at 8 Weeks
timeFrame: Baseline and 8 weeks following start of study drug administration
measure: Change From Baseline on Maintenance of Wakefulness Test (MWT) at 12 Weeks
timeFrame: baseline and 12 weeks (or last observation after baseline)
measure: Clinical Global Impression of Change (CGI-C) at 4 Weeks
timeFrame: 4 weeks after beginning study drug treatment
measure: Clinical Global Impression of Change (CGI-C) at 8 Weeks
timeFrame: 8 weeks after beginning study drug treatment
measure: Clinical Global Impression of Change (CGI-C) at 12 Weeks
timeFrame: 12 weeks after beginning treatment
measure: Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale
timeFrame: 4 weeks after start of treatment
measure: Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale
timeFrame: 8 weeks after start of study drug treatment
measure: Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale
timeFrame: 12 weeks after starting study drug treatment
measure: Change From Baseline on Epworth Sleepiness Scale (ESS) at 2 Weeks
timeFrame: Baseline and 2 weeks following start of study drug administration
measure: Change From Baseline on Epworth Sleepiness Scale (ESS) at 4 Weeks
timeFrame: Baseline and 4 weeks after start of study drug administration
measure: Change From Baseline on Epworth Sleepiness Scale (ESS) at 8 Weeks
timeFrame: Baseline and 8 weeks after start of study drug administration
measure: Change From Baseline on Epworth Sleepiness Scale (ESS) at 12 Weeks
timeFrame: 12 weeks (or last observation after baseline)
measure: Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 2 Weeks
timeFrame: 2 weeks
measure: Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 4 Weeks
timeFrame: 4 weeks
measure: Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 8 Weeks
timeFrame: 8 weeks
measure: Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 12 Weeks
timeFrame: 12 weeks
measure: Change From Baseline to Endpoint (Week 12 or Last Observation After Baseline) in the Brief Fatigue Inventory (BFI) Total Score
timeFrame: Baseline and 12 weeks following start of study drug administration or last recorded observation
measure: Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 2 Weeks
timeFrame: Baseline and 2 weeks after start of study drug administration
measure: Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 4 Weeks
timeFrame: Baseline and 4 weeks after start of study drug administration
measure: Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 8 Weeks
timeFrame: Baseline and 8 weeks after start of study drug administration
measure: Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 12 Weeks
timeFrame: Baseline and 12 weeks after start of study drug administration
measure: Change From Baseline on the Brief Fatigue Inventory (BFI) Worst Daily Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline)
timeFrame: Baseline and 12 weeks or last observation after baseline
measure: Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 2 Weeks
timeFrame: Baseline and 2 weeks after start of study drug administration
measure: Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 4 Weeks
timeFrame: Baseline and 4 weeks after start of study drug administration
measure: Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 8 Weeks
timeFrame: Baseline and 8 weeks after start of study drug administration
measure: Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 12 Weeks
timeFrame: 12 weeks
measure: Number of Responders According to Brief Fatigue Inventory (BFI) Worst Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline)
timeFrame: 12 weeks after start of study drug administration (or last observation after baseline)
measure: Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 2 Weeks
timeFrame: 2 weeks after start of study drug administration
measure: Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 4 Weeks
timeFrame: 4 weeks after start of study drug administration
measure: Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 8 Weeks
timeFrame: 8 weeks after start of study drug administration
measure: Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 12 Weeks
timeFrame: 12 weeks after start of study drug administration
measure: Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at Endpoint (12 Weeks or Last Observation After Baseline)
timeFrame: Baseline and at endpoint (12 weeks or last observation after baseline)
measure: Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 2 Weeks
timeFrame: Baseline and 2 weeks after start of study drug administration
measure: Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 4 Weeks
timeFrame: Baseline and 4 weeks after start of study drug administration
measure: Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 8 Weeks
timeFrame: Baseline and 8 weeks after start of study drug administration
measure: Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 12 Weeks (or Last Observation After Baseline)
timeFrame: Baseline and 12 weeks after start of study drug administration
measure: Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (12 Weeks or Last Observation After Baseline)
timeFrame: Baseline and endpoint (12 weeks after start of study drug or last observation after baseline)
measure: Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks
timeFrame: baseline and 2 weeks following start of study drug administration
measure: Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 4 Weeks
timeFrame: baseline and 4 weeks following start of study drug administration
measure: Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 8 Weeks
timeFrame: baseline and 8 weeks following start of study drug administration
measure: Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 12 Weeks
timeFrame: baseline and 12 weeks following the start of study drug administration
measure: Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (Week 12 or Last Observation After Baseline)
timeFrame: Endpoint (week 12 or last observation after baseline)
measure: Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks
timeFrame: 2 weeks following start of study drug administration
measure: Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 4
timeFrame: 4 weeks following start of study drug administration
measure: Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 8
timeFrame: 8 weeks following start of study drug administration
measure: Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 12
timeFrame: 12 weeks following the start of study drug administration
measure: Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at Endpoint (12 Weeks or Last Observation After Baseline)
timeFrame: Baseline and Endpoint (12 weeks or last observation after baseline)
measure: Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 2 Weeks
timeFrame: baseline and 2 weeks
measure: Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 4 Weeks
timeFrame: baseline and 4 weeks following start of study drug administration
measure: Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 8 Weeks
timeFrame: baseline and 8 weeks following start of study drug administration
measure: Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 12 Weeks
timeFrame: baseline and 12 weeks following start of study drug administration
measure: Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at Endpoint (12 Weeks or Last Observation After Baseline)
timeFrame: Baseline and Endpoint (12 weeks or last observation after baseline)
measure: Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 2 Weeks
timeFrame: Baseline and 2 weeks
measure: Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 4 Weeks
timeFrame: Baseline and 4 weeks following start of study drug administration
measure: Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 8 Weeks
timeFrame: baseline and 8 weeks following start of study drug administration
measure: Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 12 Weeks
timeFrame: Baseline and 12 weeks following start of study drug administration
Other outcomes:
Locations:
city: Jasper
country: United States
facility: Jasper Summit Research, LLC
state: Alabama
city: Phoenix
country: United States
facility: Pulmonary Associates, P.A.
state: Arizona
city: Phoenix
country: United States
facility: Psypharma Clinical Research
state: Arizona
city: Tucson
country: United States
facility: PsyPharm Clinical Research, Inc.
state: Arizona
city: Glendale
country: United States
facility: Behavioral Research Specialists
state: California
city: Glendale
country: United States
facility: California Clinical Trials Medical Group, Inc.
state: California
city: Redlands
country: United States
facility: Pacific Sleep Medicine Services, Inc.
state: California
city: San Diego
country: United States
facility: Pacific Research Network, Inc.
state: California
city: San Diego
country: United States
facility: Pacific Sleep Medicine Services, Inc.
state: California
city: San Diego
country: United States
facility: California Clinical Trials Medical Group, Inc.
state: California
city: Santa Ana
country: United States
facility: SDS Clinical Research
state: California
city: Santa Monica
country: United States
facility: St. Johns Medical Plaza Sleep Disorders Center
state: California
city: Denver
country: United States
facility: National Jewish Medical and Research Center
state: Colorado
city: Wheat Ridge
country: United States
facility: Rocky Mountain Center for Clinical Research
state: Colorado
city: Brandon
country: United States
facility: PAB Clinical Research
state: Florida
city: Spring Hill
country: United States
facility: Florida Sleep Institute
state: Florida
city: St. Petersburg
country: United States
facility: Clinical Research Group of St. Petersburg
state: Florida
city: Tampa
country: United States
facility: SomnoMedics
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials, LLC
state: Florida
city: Winter Park
country: United States
facility: Florida Pulmonary Research Center, LLC
state: Florida
city: Atlanta
country: United States
facility: The Sleep Disorders Center
state: Georgia
city: Atlanta
country: United States
facility: Neurotrials Research, Inc
state: Georgia
city: Atlanta
country: United States
facility: Sleep Disorders Center of Georgia
state: Georgia
city: Macon
country: United States
facility: SleepMed, Inc
state: Georgia
city: Chicago
country: United States
facility: Chicago Research Center
state: Illinois
city: Peoria
country: United States
facility: Peoria Pulmonary Associates
state: Illinois
city: Vernon Hills
country: United States
facility: Sleep and Behavior Medicine
state: Illinois
city: Danville
country: United States
facility: The Center for Sleep and Wake Disorders
state: Indiana
city: Overland Park
country: United States
facility: Vince & Associates Clinical Research
state: Kansas
city: Bowling Green
country: United States
facility: Graves Gilbert Clinic
state: Kentucky
city: Crestview
country: United States
facility: Community Research
state: Kentucky
city: Shreveport
country: United States
facility: Clinical Trials of America
state: Louisiana
city: Chevy Chase
country: United States
facility: The Center for Sleep & Wake Disorders
state: Maryland
city: Brighton
country: United States
facility: Sleep Health Centers
state: Massachusetts
city: Fall River
country: United States
facility: AccelRx Research
state: Massachusetts
city: Hattiesburg
country: United States
facility: The Center for Sleep Medicine
state: Mississippi
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Lincoln
country: United States
facility: Somnos Sleep Center
state: Nebraska
city: Brooklyn
country: United States
facility: Brooklyn Medical Institute
state: New York
city: New York City
country: United States
facility: Clinilabs, Inc
state: New York
city: West Seneca
country: United States
facility: Sleep Medicine Centers
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Hickory
country: United States
facility: Clinical Trials of America
state: North Carolina
city: Cincinnati
country: United States
facility: Tri-State Sleep Disorders Center
state: Ohio
city: Dublin
country: United States
facility: Ohio Sleep Medicine Institute
state: Ohio
city: Middleburg Heights
country: United States
facility: North Star Medical Research, LLC
state: Ohio
city: Toledo
country: United States
facility: St. Vincent Mercy Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Clarks Summit
country: United States
facility: Sleep Lab of Northeastern PA
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Center for Sleep
state: Pennsylvania
city: Philadelphia
country: United States
facility: CRI Worldwide
state: Pennsylvania
city: West Chester
country: United States
facility: University Services
state: Pennsylvania
city: Lincoln
country: United States
facility: AccelRx Research
state: Rhode Island
city: Charleston
country: United States
facility: Lowcountry Lung and Critical Care
state: South Carolina
city: Columbia
country: United States
facility: SleepMed of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Sleep Medicine of Middle Tennessee
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Dallas
country: United States
facility: Sleep Medicine Associates of Texas, P.A.
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine VAMC Sleep Research
state: Texas
city: Houston
country: United States
facility: Houston Sleep Center
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research
state: Washington
city: Seattle
country: United States
facility: Pacific Sleep Medicine Services, Inc.
state: Washington
Study officials:
References:
citation: 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.