Status:
COMPLETED
Provigil in Conjunction With SSRIs for the Treatment of Mild or Moderate Depression With Attendant Symptoms of Sleepiness and Fatigue.
Lead Sponsor:
Emory University
Collaborating Sponsors:
Cephalon
Conditions:
Major Depression
Mental Health
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The main purpose of this study is to determine if Provigil® (modafinil) at a dose of 200 mg once daily is safe and effective for treating symptoms of sleepiness and fatigue associated with Major Depre...
Detailed Description
Approximately 100 male and female outpatients, who are between the ages of 18 and 65, will be enrolled at four sites in the United States. This study consists of two parts. The first part consists of ...
Eligibility Criteria
Inclusion
- Major Depressive Disorder
- MADRS score ≥ 15 at both screen \& baseline.
- Significant fatigue as evidenced by FSS ≥4 at both screen \& baseline.
- Excessive sleepiness as evidenced by ESS ≥ 10 at both screen \& baseline.
Exclusion
- Treatment refractory depression
- Serious or unstable medical condition.
- Pregnancy
- Primary diagnosis of another Axis I or II disorder
- Alcohol or substance abuse or dependence within the past 12 months.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
End Date :
October 1 2004
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00208715
Start Date
February 1 2003
End Date
October 1 2004
Last Update
November 11 2013
Active Locations (4)
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1
Stanford University
Stanford, California, United States, 94305
2
Emory University
Atlanta, Georgia, United States, 30329
3
Mount Sinai School of Medicine
New York, New York, United States, 10029
4
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104