Bupropion and Restless Legs Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Max Bayard, East Tennessee State University
ClinicalTrials.gov Identifier:
NCT00621517
First received: February 12, 2008
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Restless Legs Syndrome
Drug: Bupropion
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bupropion and Restless Legs Syndrome

Resource links provided by NLM:


Further study details as provided by East Tennessee State University:

Primary Outcome Measures:
  • Change in International Restless Legs Syndrome Study Group (IRLSSG) Severity Scale. [ Time Frame: Baseline, three weeks, and six weeks ] [ Designated as safety issue: No ]
    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.

  • Clinical Global Impression - Improvement Scale [ Time Frame: three weeks and six weeks ] [ Designated as safety issue: No ]
  • Ordinal Scale(i.e., 1-8)of Symptom Severity [ Time Frame: three weeks and six weeks ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: February 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive 150MG Bupropion nightly.
Drug: Bupropion
Partipants will receive 150 mg bupropion per night
Other Name: Wellbutrin
Placebo Comparator: 2
Participants will receive matching placebo capsule nightly.
Drug: Placebo
1 capsule nightly for six weeks

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621517

Locations
United States, Tennessee
East Tennessee State University
Johnson City, Tennessee, United States, 37614
Sponsors and Collaborators
East Tennessee State University
  More Information

No publications provided

Responsible Party: Max Bayard, Associate Professor of Family Medicine, East Tennessee State University
ClinicalTrials.gov Identifier: NCT00621517     History of Changes
Other Study ID Numbers: ETSU-07-061f
Study First Received: February 12, 2008
Results First Received: March 4, 2012
Last Updated: April 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by East Tennessee State University:
Restless Legs Syndrome
Bupropion

Additional relevant MeSH terms:
Restless Legs Syndrome
Psychomotor Agitation
Nervous System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Parasomnias
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014