Bupropion and Restless Legs Syndrome - Full Text View

Sponsored by:	East Tennessee State University
Information provided by:	East Tennessee State University
ClinicalTrials.gov Identifier:	NCT00621517

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 II Phase III

MedlinePlus related topics: Restless Legs

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Bupropion and Restless Legs Syndrome

Further study details as provided by East Tennessee State University:

Primary Outcome Measures:

Change in International Restless Legs Syndrome Study Group severity scale [ Time Frame: weekly for six weeks ] [ Designated as safety issue: No ]
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 ]

Estimated Enrollment:	100
Study Start Date:	February 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Participants will receive 150MG Bupropion nightly.	Drug: Bupropion 150 MG per day for six weeks
2: Placebo Comparator 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

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

Contacts

Contact: Max Bayard, M.D.	423 439-6471	bayard@etsu.edu
Contact: Beth Bailey, PhD	423 439-6458	nordstro@etsu.edu

Locations

United States, Tennessee
East Tennessee State University	Recruiting
Johnson City, Tennessee, United States, 37614
Contact: Max Bayard, M.D. 423-439-6471 bayard@etsu.edu
Principal Investigator: Max Bayard, M.D.
Sub-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.

Sponsors and Collaborators

East Tennessee State University

More Information

No publications provided

Responsible Party:	East Tennessee State University ( Max Bayard, M.D., Principal Investigator )
Study ID Numbers:	ETSU-07-061f
Study First Received:	February 12, 2008
Last Updated:	February 21, 2008
ClinicalTrials.gov Identifier:	NCT00621517 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by East Tennessee State University:

Restless Legs Syndrome
Bupropion

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Psychotropic Drugs
Sleep Disorders
Dyssomnias
Psychomotor Agitation
Dyskinesias
Sleep Disorders, Intrinsic
Signs and Symptoms

Dopamine
Mental Disorders
Restless Legs Syndrome
Bupropion
Neurologic Manifestations
Dopamine Agents
Antidepressive Agents, Second-Generation
Neurobehavioral Manifestations
Antidepressive Agents

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Sleep Disorders
Psychomotor Agitation
Sleep Disorders, Intrinsic
Signs and Symptoms
Pathologic Processes
Mental Disorders
Syndrome
Therapeutic Uses
Restless Legs Syndrome

Psychomotor Disorders
Antidepressive Agents, Second-Generation
Neurobehavioral Manifestations
Antidepressive Agents
Disease
Parasomnias
Nervous System Diseases
Dyssomnias
Dyskinesias
Pharmacologic Actions
Bupropion
Neurologic Manifestations
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 06, 2009