Bupropion and Restless Legs Syndrome

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

Detailed Description
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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.

Official Title
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Bupropion and Restless Legs Syndrome

Conditions
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Restless Legs Syndrome

Intervention / Treatment
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* Drug: Bupropion
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants will receive 150MG Bupropion nightly. | Drug: Bupropion<br>* Partipants will receive 150 mg bupropion per night<br>* Other names: Wellbutrin;|
| Placebo Comparator: 2<br>Participants will receive matching placebo capsule nightly. | Drug: Placebo<br>* 1 capsule nightly for six weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale. | 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. | Baseline, three weeks, and six weeks | 
| Clinical Global Impression - Improvement Scale |  | three weeks and six weeks | 
| Ordinal Scale (i.e., 1-8) of Symptom Severity |  | three weeks and six weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Restless Legs Syndrome, Bupropion