Last updated: 11/04/2018 10:31:41

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

GSK study ID
RRL106721
See study documents
Clinicaltrials.gov ID
NCT00357097
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Average change of the MADRS (Montgomery-Asberg Depression Rating Scale) total score from Baseline to final visit after 12 weeks of Treatment

Timeframe: Baseline and Week 12

Secondary outcomes:

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)

Timeframe: Baseline and Week 12

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

Timeframe: Baseline and Week 12

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

Timeframe: Baseline and Week 12

Average change of the Beck Depression Inventory (BDI) total score from Baseline to final visit after 12 weeks of Treatment

Timeframe: Baseline and Week 12

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

Timeframe: Baseline and Week 12

Percentage of participants with at least moderate depression (MADRS Score >= 18) at baseline and in week 12

Timeframe: Baseline and Week 12

Percentage of participants with at least moderate depression (HAM-D >= 15) at baseline and in week 12

Timeframe: Baseline and Week 12

Percentage of participants (“Responder”) with a decrease of MADRS total score of at least 6 points after 12 weeks compared to baseline

Timeframe: Baseline and Week 12

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)

Timeframe: Baseline and Week 12

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)

Timeframe: Baseline and Week 12

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)

Timeframe: Baseline and Week 12

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)

Timeframe: Baseline and Week 12

Change in average International Restless Legs Scale for Severity (IRLS) Scores in all participants from baseline to after 1, 4, and 12 weeks

Timeframe: Baseline, Week 1, Week 4, Week 12

Percentage of participants with a decrease of International Restless Legs Scale (IRLS) scores of at least 6 points after 1, 4 and 12 weeks

Timeframe: Week 1, Week 4, Week 12

Percentage of participants with “much improved” or “very much improved” on the Clinical Global Impression-Global Improvement Scale after 1, 4 and 12 weeks

Timeframe: Week 1, Week 4, Week 12

Change from Average Baseline score of Subscale of “Somnolence” in the Medical Outcomes Study Sleep Scale (MOS-SS) to final visit after 12 weeks

Timeframe: Baseline and after Week 12

Change from Average Baseline scores of subscale “Sleep disturbance” of the Medical Outcomes Study Sleep Scale (MOS-SS) to final visit after 12 weeks

Timeframe: Baseline and after Week 12

Change from Average Baseline scores of subscale “Sleep adequacy” of the Medical Outcomes Study Sleep Scale (MOS-SS)to final visit after 12 weeks

Timeframe: Baseline and after Week 12

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

Timeframe: Baseline and after Week 12

Interventions:
  • Drug: Ropinirole
    • Enrollment:
    240
    Primary completion date:
    2007-14-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Restless Legs Syndrome
    Product
    ropinirole
    Collaborators
    Not applicable
    Study date(s)
    June 2006 to December 2007
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 79 years
    Accepts healthy volunteers
    No
    • 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)
    • 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
    Inclusion and exclusion 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 (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
    • 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).

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Ellwangen, Baden-Wuerttemberg, Germany, 73479
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Goettingen, Niedersachsen, Germany, 37075
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Bochum, Nordrhein-Westfalen, Germany, 44805
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Oldenburg, Schleswig-Holstein, Germany, 26122
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Koethen, Sachsen-Anhalt, Germany, 06366
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Guetersloh, Nordrhein-Westfalen, Germany, 33330
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 50 Results

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-14-12
    Actual study completion date
    2007-14-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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