Provigil in Conjunction With SSRIs for the Treatment of Mild or Moderate Depression With Attendant Symptoms of Sleepiness and Fatigue.
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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 |
- Epworth Sleepiness Scale (ESS)
- Hamilton Depression Scale (HAM-D 31 item)
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2003 |
| Estimated Study Completion Date: | October 2004 |
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 |
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| 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 | |
| Principal Investigator: | Philip T Ninan, MD | Emory University |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00208715 History of Changes |
| Other Study ID Numbers: | 1021-2002 |
| Study First Received: | September 13, 2005 |
| Last Updated: | September 13, 2005 |
| 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 |
Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on May 21, 2013