Provigil in Conjunction With SSRIs for the Treatment of Mild or Moderate Depression With Attendant Symptoms of Sleepiness and Fatigue.
Information source: Emory University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depression; Mental Health
Intervention: Provigil (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Emory University Official(s) and/or principal investigator(s):
Philip T Ninan, MD, Principal Investigator, Affiliation: Emory University
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Epworth Sleepiness Scale (ESS)
Secondary outcome: Hamilton Depression Scale (HAM-D 31 item)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Stanford University, Stanford, California 94305, United States
Emory University, Atlanta, Georgia 30329, United States
Mount Sinai School of Medicine, New York, New York 10029, United States
University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
Additional Information
Starting date: February 2003
Ending date: October 2004
Last updated: September 13, 2005
|
