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

This study has been completed.
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
Emory University
ClinicalTrials.gov Identifier:
NCT00208715
First received: September 13, 2005
Last updated: November 8, 2013
Last verified: November 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Emory University
ClinicalTrials.gov Identifier: NCT00208715     History of Changes
Other Study ID Numbers: 1021-2002
Study First Received: September 13, 2005
Last Updated: November 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Modafinil
Armodafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014