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

Major Depression Clinical Trial

Official title:

A DOUBLE-BLIND PILOT STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PROVIGIL® (MODAFINIL) AT FIXED/FLEXIBLE DOSES, IN CONJUNCTION WITH IDENTIFIED SSRIs FOR THE TREATMENT OF EXCESSIVE SLEEPINESS IN PATIENTS WITH MILD TO MODERATE DEPRESSION WITH ATTENDANT SYMPTOMS OF SLEEPINESS AND FATIGUE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00208715
• Other study ID #: 1021-2002
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: November 8, 2013
• Start date: February 2003
• Est. completion date: October 2004

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression
• Mental Health

Intervention

Drug:
• Provigil

Locations

Country	Name	City	State
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	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Cephalon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epworth Sleepiness Scale (ESS)
Secondary	Hamilton Depression Scale (HAM-D 31 item)