Expired Study
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Johnson City, Tennessee 37614


Purpose:

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


Study 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.


Criteria:

Inclusion Criteria: - clinical diagnosis of Restless Legs Syndrome - Severity Scale score 15 or higher Exclusion Criteria: - History of seizures - History of alcohol use greater than 2 drinks per day or occasional binges of 5 or more drinks 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


NCT ID:

NCT00621517


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Johnson City, Tennessee 37614
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 17, 2018

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