Bupropion and Restless Legs Syndrome

NCT ID: NCT00621517

Last Updated: 2019-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-07-31

Brief Summary

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

Detailed 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.

Conditions

Restless Legs Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Participants will receive 150MG Bupropion nightly.

Group Type: EXPERIMENTAL

Bupropion

Intervention Type: DRUG

Partipants will receive 150 mg bupropion per night

2

Participants will receive matching placebo capsule nightly.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1 capsule nightly for six weeks

Interventions

Bupropion

Partipants will receive 150 mg bupropion per night

Intervention Type: DRUG

Placebo

1 capsule nightly for six weeks

Intervention Type: DRUG

Other Intervention Names

Wellbutrin

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

East Tennessee State University

OTHER

Sponsor Role: lead

Responsible Party

Max Bayard

Associate Professor of Family Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

East Tennessee State University

Johnson City, Tennessee, United States

Countries

United States

Other Identifiers

ETSU-07-061f

Identifier Type: -

Identifier Source: org_study_id