Provigil in Conjunction With SSRIs for the Treatment of Mild or Moderate Depression With Attendant Symptoms of Sleepiness and Fatigue.

Completed · Phase 4

Conditions studied: Major Depression, Mental Health

In brief

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 Depressive Disorder when added to a SSRI.

Key facts

Study ID

NCT00208715

Run by

Emory University

People needed

100

Starts

2003-02-01

Expected to finish

2004-10-01

Last updated by the study team

2013-11-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Stanford University — Stanford, California, United States
• Emory University — Atlanta, Georgia, United States
• Mount Sinai School of Medicine — New York, New York, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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