Provigil in Conjunction With SSRIs for the Treatment of Mild or Moderate Depression With Attendant Symptoms of Sleepiness and Fatigue.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00208715|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : November 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Major Depression Mental Health||Drug: Provigil||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|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 Start Date :||February 2003|
|Estimated Study Completion Date :||October 2004|
- Epworth Sleepiness Scale (ESS)
- Hamilton Depression Scale (HAM-D 31 item)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00208715
|United States, California|
|Stanford, California, United States, 94305|
|United States, Georgia|
|Atlanta, Georgia, United States, 30329|
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Philip T Ninan, MD||Emory University|