Bupropion and Restless Legs Syndrome

Condition(s) targeted: Restless Legs Syndrome

Intervention: Bupropion (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: East Tennessee State University

Overall contact:
Max Bayard, M.D., Phone: 423 439-6471, Email: bayard@etsu.edu

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

Official title: Bupropion and Restless Legs Syndrome

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:

Change in International Restless Legs Syndrome Study Group 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.

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

Max Bayard, M.D., Phone: 423 439-6471, Email: bayard@etsu.edu

East Tennessee State University, Johnson City, Tennessee 37614, United States; Recruiting
Max Bayard, M.D., Phone: 423-439-6471, Email: bayard@etsu.edu
Max Bayard, M.D., Principal Investigator
Beth Bailey, PhD, Sub-Investigator
Fred Tudiver, M.D., Sub-Investigator
Taran Kaur, M.D., Sub-Investigator
Sonia Duggal, M.D., Sub-Investigator
Farhana Ambreen, M.D., Sub-Investigator
Deep Acharya, M.D., Sub-Investigator
Zia Rahman, M.D., Sub-Investigator
Kim Roller, M.D., Sub-Investigator

Starting date: February 2008
Last updated: February 21, 2008