Bupropion and Restless Legs Syndrome

Last updated: February 14, 2019
Sponsor: East Tennessee State University
Overall Status: Completed

Phase

2/3

Condition

Williams Syndrome

Dyskinesias

Manic Disorders

Treatment

N/A

Clinical Study ID

NCT00621517
ETSU-07-061f
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • clinical diagnosis of Restless Legs Syndrome

  • Severity Scale score 15 or higher

Exclusion

Exclusion Criteria:

  • History of seizures

  • History of alcohol use greater than 2 drinks per day or occasional binges of 5 or moredrinks per day

  • Suicidal thoughts/ideations

  • Inability to return for follow up appointments at 3 and 6 weeks

  • Lack of access to telephone

  • Eating disorder

  • Age less than 18

  • Pregnancy

  • Unwillingness or inability to discontinue any RLS medications

Study Design

Total Participants: 60
Study Start date:
February 01, 2008
Estimated Completion Date:
July 31, 2009

Study Description

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.

Connect with a study center

  • East Tennessee State University

    Johnson City, Tennessee 37614
    United States

    Site Not Available

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