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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 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.

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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

Mental Health Major Depression

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

FieldValue
Enrollment Target 100 participants
Start Date 2003-02
Est. Completion 2004-10
Phase Phase 4

Sponsor

Emory University

1,208 total trials

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What the Registry Record Tells You About NCT00208715

The ClinicalTrials.gov registry entry for NCT00208715 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 10,182-participant average among 62 other Mental Health trials with a reported enrollment target (99% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.