Provigil in Conjunction With SSRIs for the Treatment of Mild or Moderate Depression With Attendant Symptoms of Sleepiness and Fatigue.
NCT00208715 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2013-11-11
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.
Conditions
Interventions
- DRUG
-
Provigil
Sponsors & Collaborators
-
Cephalon
collaborator INDUSTRY -
Emory University
lead OTHER
Principal Investigators
-
Philip T Ninan, MD · Emory University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-02-28
- Completion
- 2004-10-31
Countries
- United States
Study Locations
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