The Effects Of Ropinirole On Mood Or Mild Depression In Patients With Moderate To Severe Restless Legs Syndrome - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00357097

Purpose

Ropinirole has shown to improve mood in depressed patients as well as to improve the symptoms of Restless Legs Syndrome. Up to 40% of RLS patients suffer from mild depression, therefore it would be important for decisions no therapy to know whether a drug could improve both depressive and RLS symptoms.

Condition	Intervention	Phase
Moderate to Severe Idiopathic Restless Legs Syndrome (RLS)	Drug: Ropinirole	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Official Title:	A Multicenter 3:1-Randomized Placebo-Controlled Double-Blind Phase IIIb Study on the Effects of Ropinirole on Mood/(Subclinical) Depression in the Therapy of Patients With Moderate to Severe Idiopathic RLS in Germany

Resource links provided by NLM:

MedlinePlus related topics: Depression Restless Legs

Drug Information available for: Ropinirole hydrochloride Ropinirole

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

to compare efficacy of ropinirole and placebo on improving mood in patients with moderate to severe idiopathic RLS and some depressive symptoms, change on a depression rating scale after 12 weeks treatment with ropinirole versus placebo is measured.

Secondary Outcome Measures:

The efficacy of ropinirole in improving mood in patient with different severities of depression will be measured. Also the efficacy of ropinirole in improving the symptoms of RLS and sleep will be assessed. Some endpoints will include safety measures.
·Change from baseline at week 12 in Sleep II Index, as measured by MOS sleep scale.
·Change from baseline at week 12 in sleep quantity, as measured by the MOS sleep scale.
·Change form baseline at week 12 in somnolence, as measured by the MOS sleep scale.
·Time to response on the Clinical Global Impression (Global Improvement) (CGI) scale.
·Proportion of patients with a score of much-improved (2) or very much-improved (1) on the CGI (Global Improvement) scale at day 8, weeks 4, 8 and 12 LOCF (last observation carried forward).
·Change from baseline at week 12 in the overall life impact score on the RLS QOL Questionnaire.
·Change from baseline at week 12 in all domains of the SF-36.
·CGI improvement and severity at day 8, weeks 4, 8 and 12.
·Changes from baseline at week 12 in number of days with RLS symptoms.
·Changes from baseline at week 12 in number of awakenings per night due to RLS symptoms.
Changes from baseline in visual analogue scale score (patients own assessment of their overall health) to day 8, weeks 4, 8 and 12

Estimated Enrollment:	240
Study Start Date:	June 2006
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

diagnosis of idiopathic Restless Legs Syndrome, confirmed by a score of at least 11 on the RLS Diagnostic Index
certain severity of symptoms (at least score of 15 on the International Restless Legs Score (IRLS)
Have had RLS symptoms for at least 15 nights in the last four weeks.
< 6 hours of sleep in nights with RLS symptoms
MADRS (depression rating scale) score of at least 12 (= borderline to depression) at baseline

Exclusion criteria:

any other sleep disorder that might interfere with the RLS symptoms or sleep (e.g. sleep apnea disorder, narcolepsy)
Secondary RLS due to diagnosis of renal insufficiency, polyneuropathy, pregnancy (see below), iron deficiency anemia
Any significant psychiatric disorders (e.g. schizophrenia, bipolar disorder); depression which by judgement of the investigator is caused by RLS, is not an exclusion criterion.
Current or past suicidality
medication known to trigger/aggravate/ cause or interfere with RLS symptoms (e.g. most antidepressants, lithium, neuroleptics, opioids, carbidopa, clonidine, antihistamines, anticonvulsants etc.).
daytime RLS symptoms which require treatment (â€œdaytimeâ€: 10 a.m. until 6 p.m.).
concomitant movement disorders (e.g. Parkinsonâ€™s Disease, dyskinesia, dystonia).
medical conditions with symptoms which could affect assessments of efficacy (e.g. diabetes, rheumatoid arthritis, fibromyalgia syndrome, cancer etc.).
Subjects taking any medication known to induce drowsiness or to affect sleep.
Subjects who are pregnant, lactating or of childbearing potential. Women of childbearing potential must use adequate contraception
clinically significant or unstable medical conditions (e.g. severe heart disease, severe liver or kidney disease etc.).
pain syndromes, caused by other disorders than RLS
excessive caffeine intake
diastolic blood pressure >110mmHg or <50mmHg or systolic blood pressure >180mmHg or <90mmHg at baseline.
Withdrawal, introduction, or change in dose of hormone replacement therapy (HRT) or the oral contraceptive pill (OCP) and/or certain drugs which are known to interact with ropinirole (e.g. ciprofloxacin, cimetidine, tobacco, omeprazole).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357097

Show 50 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD, PhD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	RRL106721, EudraCT:2005-006080-31
Study First Received:	July 25, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00357097 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:

ropinirole
placebo
mood
depression
restless legs syndrome

RLS
double-blind
randomised
germany

Study placed in the following topic categories:

Neurotransmitter Agents
Ropinirole
Depression
Sleep Disorders
Dyssomnias
Psychomotor Agitation
Dopamine Agonists
Depressive Disorder
Dyskinesias
Behavioral Symptoms

Sleep Disorders, Intrinsic
Signs and Symptoms
Dopamine
Mental Disorders
Restless Legs Syndrome
Mood Disorders
Neurologic Manifestations
Dopamine Agents
Neurobehavioral Manifestations

Additional relevant MeSH terms:

Neurotransmitter Agents
Ropinirole
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Sleep Disorders
Antiparkinson Agents
Psychomotor Agitation
Dopamine Agonists
Sleep Disorders, Intrinsic
Signs and Symptoms
Pathologic Processes
Mental Disorders
Syndrome
Therapeutic Uses

Restless Legs Syndrome
Psychomotor Disorders
Neurobehavioral Manifestations
Depression
Disease
Parasomnias
Nervous System Diseases
Dyssomnias
Depressive Disorder
Dyskinesias
Pharmacologic Actions
Behavioral Symptoms
Mood Disorders
Neurologic Manifestations
Dopamine Agents

ClinicalTrials.gov processed this record on July 02, 2009