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NCT00208715 · ClinicalTrials.gov registry record · Phase 4
Provigil in Conjunction With SSRIs for the Treatment of Mild or Moderate Depression With Attendant Symptoms of Sleepiness and Fatigue.
A Phase 4 study of Mental Health and Major Depression, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 4
- Study locations
NCT00208715: Completed Phase 4 study of Mental Health and Major Depression, sponsored by Emory University.
NCT00208715 is a Phase 4 study of Mental Health and Major Depression that has completed, run by Emory University. The registered enrollment target is 100 participants, below the 10,182-participant average among 62 other Mental Health trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00208715, a Phase 4 study of Mental Health and Major Depression, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 4
- Study locations
Study 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 Studied
Interventions
- DRUG Provigil
Study Locations (4)
California
- Stanford University - Stanford
Georgia
- Emory University - Atlanta
New York
- Mount Sinai School of Medicine - New York
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2003-02 |
| Est. Completion | 2004-10 |
| Phase | Phase 4 |
What the finished NCT00208715 record still lists
NCT00208715 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 10,182-participant average among 62 other Mental Health trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Mental Health appearing as the primary indexed condition, and to 1 intervention - of which Provigil is the first listed.
NCT00208715 reports a single indexed study location in California, Georgia, New York.
Frequently Asked Questions
What is clinical trial NCT00208715 about?
NCT00208715 is a clinical study titled "Provigil in Conjunction With SSRIs for the Treatment of Mild or Moderate Depression With Attendant Symptoms of Sleepiness and Fatigue.". 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.
What is the current status of trial NCT00208715?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2003-02. Estimated completion is 2004-10.
What conditions does trial NCT00208715 study?
This clinical trial studies the following conditions: Mental Health, Major Depression.
What interventions are being tested in trial NCT00208715?
The interventions under investigation include: Provigil (DRUG).
Who is sponsoring clinical trial NCT00208715?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00208715 being conducted?
This trial has 4 study locations across California, Georgia, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00208715's enrollment target sits among peer trials
100 48th of 62 higher than 13 of 62 other Mental Health trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mental Health trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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