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Provigil in Conjunction With SSRIs for the Treatment of Mild or Moderate Depression With Attendant Symptoms of Sleepiness and Fatigue.

NCT ID: NCT00208715

Last Updated: 2013-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2004-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Major Depression Mental Health

Keywords

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Provigil

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Major Depressive Disorder
* MADRS score ≥ 15 at both screen \& baseline.
* Significant fatigue as evidenced by FSS ≥4 at both screen \& baseline.
* Excessive sleepiness as evidenced by ESS ≥ 10 at both screen \& baseline.

Exclusion Criteria

* Treatment refractory depression
* Serious or unstable medical condition.
* Pregnancy
* Primary diagnosis of another Axis I or II disorder
* Alcohol or substance abuse or dependence within the past 12 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cephalon

INDUSTRY

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philip T Ninan, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Stanford University

Stanford, California, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Mount Sinai School of Medicine

New York, New York, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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1021-2002

Identifier Type: -

Identifier Source: org_study_id