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The Effects Of Ropinirole On Mood Or Mild Depression In Patients With Moderate To Severe Restless Legs Syndrome
This study has been completed.
Study NCT00357097   Information provided by GlaxoSmithKline
First Received: July 25, 2006   Last Updated: August 11, 2009   History of Changes

July 25, 2006
August 11, 2009
June 2006
December 2007   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00357097 on ClinicalTrials.gov Archive Site
  • 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 ]
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.
 
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

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.

 
Phase III
Interventional
Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Moderate to Severe Idiopathic Restless Legs Syndrome (RLS)
Drug: Ropinirole
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
266
December 2007
December 2007   (final data collection date for primary outcome measure)

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. 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
  • 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).
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00357097
Study Director, GSK
RRL106721, EudraCT:2005-006080-31
GlaxoSmithKline
 
Study Director: GSK Clinical Trials, MD, PhD GlaxoSmithKline
GlaxoSmithKline
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP