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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

September 13, 2005

Start Date ^ICMJE

February 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Epworth Sleepiness Scale (ESS)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Hamilton Depression Scale (HAM-D 31 item)

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Major Depression
Mental Health

Intervention ^ICMJE

Drug: Provigil

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

October 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00208715

Responsible Party

Study ID Numbers ^ICMJE

1021-2002

Study Sponsor ^ICMJE

Emory University

Collaborators ^ICMJE

Cephalon

Investigators ^ICMJE

Principal Investigator:

Philip T Ninan, MD

Emory University

Information Provided By

Emory University

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP