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

Phase 4

Completed

• Conditions: Major Depression; Mental Health

• Registration Number: NCT00208715
• Lead Sponsor: Emory University

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 Depressive Disorder when added to a SSRI.

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 6 weeks of open label treatment with a selected SSRI \& double blind treatment with Provigil or placebo (inactive medication).

After the six week double blind treatment phase all patients will enter a four week open label treatment phase with Provigil. The dose of Provigil is not to exceed 400 mg and cannot be less than 100 mg per day. They will continue taking the prescribed SSRI.

Study Timeline

• Study Start: 2003-02
• Study Completion: 2004-10
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-08
• Last Update Posted: 2013-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Epworth Sleepiness Scale (ESS)

Secondary Outcome Measures

Name	Time	Method
Hamilton Depression Scale (HAM-D 31 item)

Trial Locations

Locations (4)

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