- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00208715
Provigil in Conjunction With SSRIs for the Treatment of Mild or Moderate Depression With Attendant Symptoms of Sleepiness and Fatigue.
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
Study Overview
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 Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University
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Georgia
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Atlanta, Georgia, United States, 30329
- Emory University
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New York
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New York, New York, United States, 10029
- Mount Sinai School of Medicine
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Epworth Sleepiness Scale (ESS)
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Secondary Outcome Measures
Outcome Measure |
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Hamilton Depression Scale (HAM-D 31 item)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Philip T Ninan, MD, Emory University
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Sleepiness
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Central Nervous System Stimulants
- Wakefulness-Promoting Agents
- Modafinil
Other Study ID Numbers
- 1021-2002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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