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Sponsored by: |
Cephalon |
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Information provided by: | Cephalon |
ClinicalTrials.gov Identifier: | NCT00518986 |
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 |
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 |
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 |
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1: Active Comparator
armodafinil 200 mg/day
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Drug: armodafinil
200 mg/day
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2: Placebo Comparator
Placebo
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Drug: placebo
placebo
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Cephalon Contact | 1-877-CEPH-TRY |
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 |
Obstructive Sleep Apnea/Hypopnea Syndrome Excessive Sleepiness |
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 |
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 |