Bupropion and Restless Legs Syndrome
The purpose of this study is to determine if bupropion will improve the symptoms of restless legs syndrome (RLS).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Bupropion and Restless Legs Syndrome|
- Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale. [ Time Frame: Baseline, three weeks, and six weeks ] [ Designated as safety issue: No ]Scale ranges from 0 to 40 points with higher scores being associated with more severe symptoms of restless legs syndrome. There are 10 questions, with points of 0 to 4 per question. The change in IRLSSG score from baseline is recorded at three and six weeks.
- Clinical Global Impression - Improvement Scale [ Time Frame: three weeks and six weeks ] [ Designated as safety issue: No ]
- Ordinal Scale(i.e., 1-8)of Symptom Severity [ Time Frame: three weeks and six weeks ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Participants will receive 150MG Bupropion nightly.
Partipants will receive 150 mg bupropion per night
Other Name: Wellbutrin
Placebo Comparator: 2
Participants will receive matching placebo capsule nightly.
1 capsule nightly for six weeks
Adult patients with moderate to severe RLS will be recruited for the study. Those on medications which treat RLS will be asked to discontinue the medications for two weeks prior to beginning the study. All participants will be screened with Beck Depression Inventory, International Restless Legs Syndrome Study Group (IRLSSG) severity scale, and Clinical Global Impression of Improvement (CGI-I) scale. An ordinal scale (i.e. rate symptoms from 1-8) will also be obtained. Participants will be randomized to a placebo or medication group. Those in the medication group will be given 150 mg of bupropion at night for six weeks. Others will receive similar-appearing placebo. Participants will be called at the end of weeks one, two, four and five to assess symptom severity based on IRLSSG scale, and to determine if they are experiencing any adverse effects. At three weeks and six weeks, participants will return to the clinic to complete all four of the initial forms, the Beck Depression Inventory, IRLSSG severity scale, ordinal scale, and CGI-I.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00621517
|United States, Tennessee|
|East Tennessee State University|
|Johnson City, Tennessee, United States, 37614|