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

Sponsor:	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 on 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:

Average Change of the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score From Baseline to Final Visit After 12 Weeks of Treatment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Average Change of the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score From Baseline to Final Visit After 12 Weeks of Treatment in Participants With Signs of at Least Moderate Depression (MADRS Score: >=18) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Average Change of the HAM-D (Hamilton Depression Rating Scale, 17-item-Version) Total Score From Baseline to Final Visit After 12 Weeks of Treatment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Average Change of the HAM-D Total Score From Baseline to Final Visit After 12 Weeks of Treatment in Participants With Signs of an at Least Moderate Depression (HAM-D Score >= 15) at Baseline [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Average Change of the Beck Depression Inventory (BDI) Total Score From Baseline to Final Visit After 12 Weeks of Treatment [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Average Change of the Beck Depression Inventory (BDI) Total Score From Baseline to Final Visit After 12 Weeks of Treatment in Participants With Signs of an at Least Mild-moderate Depression (BDI >= 21) at Baseline [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Percentage of Participants With at Least Moderate Depression (MADRS Score >= 18) at Baseline and in Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Percentage of Participants With at Least Moderate Depression (HAM-D >= 15) at Baseline and in Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Percentage of Participants ("Responder") With a Decrease of MADRS Total Score of at Least 6 Points After 12 Weeks Compared to Baseline [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Percentage of Participants ("Responder") With a Decrease of MADRS Total Score of at Least 6 Points After 12 Weeks Compared to Baseline in Subjects With Signs of at Least Moderate Depression at Baseline (MADRS Score >= 18) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Change in Average MADRS Score From Baseline to Final Visit (Week 12) in Participants With Major Depressive Episodes (Diagnosed by MINI Interview Modules A, B and C / DSM Criteria) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Change in Average HAM-D Score From Baseline to Final Visit (Week 12) in Participants With Major Depressive Episodes (Diagnosed by MINI Interview Modules A, B and C / DSM Criteria) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Change in Average BDI Score From Baseline to Final Visit (Week 12) in Participants With Major Depressive Episodes (Diagnosed by MINI Interview Modules A, B and C / DSM Criteria) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Change in Average International Restless Legs Scale for Severity (IRLS) Scores in All Participants From Baseline to After 1, 4, and 12 Weeks [ Time Frame: Baseline, Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
Percentage of Participants With a Decrease of International Restless Legs Scale (IRLS) Scores of at Least 6 Points After 1, 4 and 12 Weeks [ Time Frame: Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
Percentage of Participants With "Much Improved" or "Very Much Improved" on the Clinical Global Impression-Global Improvement Scale After 1, 4 and 12 Weeks [ Time Frame: Week 1, Week 4, Week 12 ] [ Designated as safety issue: No ]
Change From Average Baseline Score of Subscale of "Somnolence" in the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks [ Time Frame: Baseline and after Week 12 ] [ Designated as safety issue: No ]
Change From Average Baseline Scores of Subscale "Sleep Disturbance" of the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks [ Time Frame: Baseline and after Week 12 ] [ Designated as safety issue: No ]
Change From Average Baseline Scores of Subscale "Sleep Adequacy" of the Medical Outcomes Study Sleep Scale (MOS-SS)to Final Visit After 12 Weeks [ Time Frame: Baseline and after Week 12 ] [ Designated as safety issue: No ]
Change From Average Baseline Scores of Subscale "Sleep Quantity" (Hours) of the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks [ Time Frame: Baseline and after Week 12 ] [ Designated as safety issue: No ]

Enrollment:	266
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 (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

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Locations

Germany
GSK Investigational Site
Berlin, Germany, 10629
GSK Investigational Site
Berlin, Germany, 10787
GSK Investigational Site
Berlin, Germany, 13053
GSK Investigational Site
Berlin, Germany, 10117
GSK Investigational Site
Berlin, Germany, 13156
GSK Investigational Site
Berlin, Germany, 10969
GSK Investigational Site
Berlin, Germany, 12167
GSK Investigational Site
Berlin, Germany, 10625
Germany, Baden-Wuerttemberg
GSK Investigational Site
Ostfildern, Baden-Wuerttemberg, Germany, 73760
GSK Investigational Site
Ellwangen, Baden-Wuerttemberg, Germany, 73479
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89081
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89073
Germany, Bayern
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
GSK Investigational Site
Nuernberg, Bayern, Germany, 90403
GSK Investigational Site
Muenchen, Bayern, Germany, 80331
GSK Investigational Site
Unterhaching, Bayern, Germany, 82008
GSK Investigational Site
Regensburg, Bayern, Germany, 93053
GSK Investigational Site
Freiburg, Bayern, Germany, 79104
Germany, Brandenburg
GSK Investigational Site
Bad Saarow, Brandenburg, Germany, 15526
Germany, Hessen
GSK Investigational Site
Bad Homburg, Hessen, Germany, 61348
GSK Investigational Site
Herborn, Hessen, Germany, 35745
GSK Investigational Site
Kassel, Hessen, Germany, 34128
GSK Investigational Site
Butzbach, Hessen, Germany, 35510
Germany, Mecklenburg-Vorpommern
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19053
GSK Investigational Site
Wismar, Mecklenburg-Vorpommern, Germany, 23966
GSK Investigational Site
Anklam, Mecklenburg-Vorpommern, Germany, 17389
Germany, Niedersachsen
GSK Investigational Site
Goettingen, Niedersachsen, Germany, 37073
GSK Investigational Site
Hildesheim, Niedersachsen, Germany, 31134
GSK Investigational Site
Achim, Niedersachsen, Germany, 28832
GSK Investigational Site
Wolfsburg, Niedersachsen, Germany, 38440
GSK Investigational Site
Goettingen, Niedersachsen, Germany, 37075
Germany, Nordrhein-Westfalen
GSK Investigational Site
Hattingen, Nordrhein-Westfalen, Germany, 45525
GSK Investigational Site
Dueren, Nordrhein-Westfalen, Germany, 52349
GSK Investigational Site
Duesseldorf, Nordrhein-Westfalen, Germany, 40212
GSK Investigational Site
Guetersloh, Nordrhein-Westfalen, Germany, 33330
GSK Investigational Site
Juelich, Nordrhein-Westfalen, Germany, 52428
GSK Investigational Site
Bielefeld, Nordrhein-Westfalen, Germany, 33647
GSK Investigational Site
Gelsenkirchen, Nordrhein-Westfalen, Germany, 45879
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44805
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44809
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44787
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44791
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44892
Germany, Rheinland-Pfalz
GSK Investigational Site
Limburgerhof, Rheinland-Pfalz, Germany, 67117
Germany, Sachsen
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
Germany, Sachsen-Anhalt
GSK Investigational Site
Halle, Sachsen-Anhalt, Germany, 06118
GSK Investigational Site
Koethen, Sachsen-Anhalt, Germany, 06366
Germany, Schleswig-Holstein
GSK Investigational Site
Oldenburg, Schleswig-Holstein, Germany, 26122
Germany, Thueringen
GSK Investigational Site
Jena, Thueringen, Germany, 07743
GSK Investigational Site
Gera, Thueringen, Germany, 07551

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
Results First Received:	December 12, 2008
Last Updated:	August 11, 2009
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

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 November 25, 2009