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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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:
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
GSK Investigational Site
Ellwangen, Baden-Wuerttemberg, Germany, 73479
Status
Study Complete
Location
GSK Investigational Site
Goettingen, Niedersachsen, Germany, 37075
Status
Study Complete
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44805
Status
Study Complete
Location
GSK Investigational Site
Oldenburg, Schleswig-Holstein, Germany, 26122
Status
Study Complete
Location
GSK Investigational Site
Koethen, Sachsen-Anhalt, Germany, 06366
Status
Study Complete
Location
GSK Investigational Site
Guetersloh, Nordrhein-Westfalen, Germany, 33330
Status
Study Complete
Location
GSK Investigational Site
Gelsenkirchen, Nordrhein-Westfalen, Germany, 45879
Status
Study Complete
Location
GSK Investigational Site
Juelich, Nordrhein-Westfalen, Germany, 52428
Status
Study Complete
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44787
Status
Study Complete
Location
GSK Investigational Site
Goettingen, Niedersachsen, Germany, 37073
Status
Study Complete
Location
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89081
Status
Study Complete
Location
GSK Investigational Site
Ostfildern, Baden-Wuerttemberg, Germany, 73760
Status
Study Complete
Location
GSK Investigational Site
Wolfsburg, Niedersachsen, Germany, 38440
Status
Study Complete
Location
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79104
Status
Study Complete
Location
GSK Investigational Site
Anklam, Mecklenburg-Vorpommern, Germany, 17389
Status
Study Complete
Location
GSK Investigational Site
Hattingen, Nordrhein-Westfalen, Germany, 45525
Status
Study Complete
Location
GSK Investigational Site
Dueren, Nordrhein-Westfalen, Germany, 52349
Status
Study Complete
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44892
Status
Study Complete
Location
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19053
Status
Study Complete
Location
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89073
Status
Study Complete
Location
GSK Investigational Site
Limburgerhof, Rheinland-Pfalz, Germany, 67117
Status
Study Complete
Location
GSK Investigational Site
Duesseldorf, Nordrhein-Westfalen, Germany, 40212
Status
Study Complete
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44791
Status
Study Complete
Location
GSK Investigational Site
Hildesheim, Niedersachsen, Germany, 31134
Status
Study Complete
Location
GSK Investigational Site
Bad Saarow, Brandenburg, Germany, 15526
Status
Study Complete
Location
GSK Investigational Site
Wismar, Mecklenburg-Vorpommern, Germany, 23966
Status
Study Complete
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44809
Status
Study Complete
Location
GSK Investigational Site
Bielefeld, Nordrhein-Westfalen, Germany, 33647
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
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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