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OpenTrials
Completed

NCT Number: NCT00208715

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.

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Key information

Conditions

Major Depression Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mental Health Mood Disorders Personal Satisfaction Psychological Well-Being

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stanford University, Stanford, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Provigil

Drug

Primary outcomes

  1. Epworth Sleepiness Scale (ESS)

Secondary outcomes

  1. Hamilton Depression Scale (HAM-D 31 item)

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Cephalon

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2004
First posted
Sep 21, 2005
Registry last updated
Nov 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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