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

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: All

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 Depressive Disorder when added to a SSRI.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: Cephalon
• Treatments: Armodafinil; Modafinil

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.