A Phase 4 interventional study of Provigil in Major Depression and Mental Health, sponsored by Emory University. Completed at 4 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-11-11.
Sponsored by Emory University · Phase 4, Interventional, and Treatment
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.
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.
166 studies on the registry are indexed under Sleepiness; 19 are open to participants now.
This study's enrollment of 100 is above the median of 80 across 125 interventional studies indexed under Sleepiness.
Browse Sleepiness studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Epworth Sleepiness Scale (ESS)
Hamilton Depression Scale (HAM-D 31 item)
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Emory University