Bupropion and Restless Legs Syndrome
Information source: East Tennessee State University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Restless Legs Syndrome
Intervention: Bupropion (Drug); Placebo (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: East Tennessee State University
Summary
The purpose of this study is to determine if bupropion will improve the symptoms of restless
legs syndrome (RLS).
Clinical Details
Official title: Bupropion and Restless Legs Syndrome
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale.Clinical Global Impression - Improvement Scale Ordinal Scale(i.e., 1-8)of Symptom Severity
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
East Tennessee State University, Johnson City, Tennessee 37614, United States
Additional Information
Starting date: February 2008
Last updated: April 4, 2012
|