Bupropion and Restless Legs Syndrome

East Tennessee State University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Restless Legs Syndrome

Treatments: Drug: Placebo; Drug: Bupropion

Study type: Interventional

Funder types: Other

Identifiers

NCT00621517

ETSU-07-061f

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Participants will receive 150MG Bupropion nightly.

Treatment:

Drug: Bupropion

2

Placebo Comparator group

Description:

Participants will receive matching placebo capsule nightly.

Treatment:

Drug: Placebo