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Study to Evaluate the Efficacy and Safety of Armodafinil as Treatment for Adults With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome With Comorbid Major Depressive Disorder or Dysthymic Disorder
This study is currently recruiting participants.
Verified by Cephalon, December 2008
Sponsored by: Cephalon
Information provided by: Cephalon
ClinicalTrials.gov Identifier: NCT00518986
  Purpose

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.


Condition Intervention Phase
Sleep Disorders
Obstructive Sleep Apnea
Major Depressive Disorder
Dysthymic Disorder
Drug: armodafinil
Drug: placebo
Phase IV

MedlinePlus related topics: Depression Sleep Apnea Sleep Disorders
Drug Information available for: Armodafinil
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Armodafinil at a Target Dosage of 200 mg/Day as Treatment for Adults With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome With Comorbid Major Depressive Disorder or Dysthymic Disorder

Further study details as provided by Cephalon:

Primary Outcome Measures:
  • MWT mean sleep latency assessed at week 12 (or last postbaseline observation) and CGI-C ratings assessed at week 12 (or last postbaseline observation). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ESS assessed at week 12 (or last postbaseline observation). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 232
Study Start Date: October 2007
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
armodafinil 200 mg/day
Drug: armodafinil
200 mg/day
2: Placebo Comparator
Placebo
Drug: placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518986

Contacts
Contact: Cephalon Contact 1-877-CEPH-TRY

  Show 62 Study Locations
Sponsors and Collaborators
Cephalon
  More Information

Responsible Party: Cephalon ( Sponsor's Medical Expert )
Study ID Numbers: C10953/4024/ES/US
Study First Received: August 17, 2007
Last Updated: December 2, 2008
ClinicalTrials.gov Identifier: NCT00518986  
Health Authority: United States: Food and Drug Administration

Keywords provided by Cephalon:
Obstructive Sleep Apnea/Hypopnea Syndrome
Excessive Sleepiness

Study placed in the following topic categories:
Sleep Apnea Syndromes
Depression
Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Dyssomnias
Sleep Disorders
Depressive Disorder, Major
Depressive Disorder
Modafinil
Sleep Disorders, Intrinsic
Behavioral Symptoms
Signs and Symptoms
Respiratory Tract Diseases
Mental Disorders
Mood Disorders
Neurologic Manifestations
Signs and Symptoms, Respiratory
Dysthymic Disorder

Additional relevant MeSH terms:
Pathologic Processes
Disease
Therapeutic Uses
Syndrome
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Stimulants
Protective Agents
Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009