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The Effects Of Ropinirole On Mood Or Mild Depression In Patients With Moderate To Severe Restless Legs Syndrome | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT00357097•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 79 years

Sex

ALL

Healthy Volunteers

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 (daytime: 10 a.m. until 6 p.m.).
•concomitant movement disorders (e.g. Parkinson'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
+5 more criteria

Locations (50)

GSK Investigational Site

Ellwangen, Baden-Wurttemberg, Germany

GSK Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

GSK Investigational Site

Ostfildern, Baden-Wurttemberg, Germany

GSK Investigational Site

Ulm, Baden-Wurttemberg, Germany

GSK Investigational Site

Ulm, Baden-Wurttemberg, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Nuremberg, Bavaria, Germany

GSK Investigational Site

Regensburg, Bavaria, Germany

GSK Investigational Site

Unterhaching, Bavaria, Germany

GSK Investigational Site

Würzburg, Bavaria, Germany

Key Dates

Start Date

June 1, 2006

Primary Completion Date

December 1, 2007

Completion Date

December 1, 2007

Last Updated

June 7, 2012

Enrollment

240

ACTUAL participants

Conditions

Restless Legs SyndromeModerate to Severe Idiopathic Restless Legs Syndrome (RLS)

Interventions

Ropinirole

DRUG

Functional Connectivity of the Interoceptive Network in RLS

NCT07001891

Restless Legs Syndrome

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RECRUITINGNA

The Application of Wide Pulse High Frequency Neuromuscular Electrical Stimulation in Disorders Associated With Motoneuron Hyperexcitability

NCT05908214

StrokeCramp+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 7, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Functional Connectivity of the Interoceptive Network in RLS

The Application of Wide Pulse High Frequency Neuromuscular Electrical Stimulation in Disorders Associated With Motoneuron Hyperexcitability

Quality Improvement and Practice Based Research in Neurology Using the EMR

A Post-Market Study for Long-Term Effectiveness and Safety of the NTX100 for RLS

Adverse Long-term Consequences of Sleep Disordered Breathing: The Ottawa Hospital (TOH) Sleep Database

Impact of Iron Supplementation Treatment on Brain Iron Concentrations