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

Sponsors and Collaborators:	Emory University Cephalon
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00208715

Purpose

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.

Condition	Intervention	Phase
Major Depression Mental Health	Drug: Provigil	Phase IV

MedlinePlus related topics: Depression Mental Health

Drug Information available for: Modafinil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Emory University:

Primary Outcome Measures:

Epworth Sleepiness Scale (ESS)

Secondary Outcome Measures:

Hamilton Depression Scale (HAM-D 31 item)

Estimated Enrollment:	100
Study Start Date:	February 2003
Estimated Study Completion Date:	October 2004

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208715

Locations

United States, California
Stanford University
Stanford, California, United States, 94305
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Emory University

Cephalon

Investigators

Principal Investigator:

Philip T Ninan, MD

Emory University

More Information

No publications provided

Study ID Numbers:	1021-2002
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00208715 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Emory University:

Depression

Study placed in the following topic categories:

Depression
Fatigue
Mental Disorders
Mood Disorders
Central Nervous System Stimulants
Depressive Disorder, Major

Depressive Disorder
Neuroprotective Agents
Serotonin Uptake Inhibitors
Modafinil
Behavioral Symptoms

Additional relevant MeSH terms:

Depression
Physiological Effects of Drugs
Central Nervous System Stimulants
Depressive Disorder, Major
Depressive Disorder
Protective Agents
Neuroprotective Agents

Modafinil
Pharmacologic Actions
Behavioral Symptoms
Mental Disorders
Therapeutic Uses
Mood Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009