Clinical Trial: Bupropion and Restless Legs Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Bupropion and Restless Legs Syndrome

Brief Summary: The purpose of this study is to determine if bupropion will improve the symptoms of restless legs syndrome (RLS).

Detailed Summary: 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.
Sponsor: East Tennessee State University

Current Primary Outcome:

  • Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale. [ Time Frame: Baseline, three weeks, and six weeks ]
    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 ]
  • Ordinal Scale(i.e., 1-8)of Symptom Severity [ Time Frame: three weeks and six weeks ]


Original Primary Outcome:

  • Change in International Restless Legs Syndrome Study Group severity scale [ Time Frame: weekly for six weeks ]
  • Clinical Global Impression - Improvement Scale [ Time Frame: three weeks and six weeks ]
  • Ordinal Scale(i.e., 1-8)of Symptom Severity [ Time Frame: three weeks and six weeks ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: East Tennessee State University

Dates:
Date Received: February 12, 2008
Date Started: February 2008
Date Completion:
Last Updated: April 4, 2012
Last Verified: April 2012