Clinical trial NCT00357097: The Effects Of Ropinirole On Mood Or Mild Depression In Patients With Moderate To Severe Restless Legs Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Restless Legs Syndrome
Moderate to Severe Idiopathic Restless Legs Syndrome (RLS)
Keywords: randomised
ropinirole
depression
RLS
placebo
mood
double-blind
restless legs syndrome
germany
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-07-27
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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).

Primary outcomes:
measure: 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:
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: Percentage of Participants With at Least Moderate Depression (MADRS Score >= 18) at Baseline and in Week 12
timeFrame: Baseline and Week 12
measure: Percentage of Participants With at Least Moderate Depression (HAM-D >= 15) at Baseline and in Week 12
timeFrame: Baseline and Week 12
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
Other outcomes:
Locations:
city: Ellwangen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Freiburg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Ostfildern
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Ulm
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Ulm
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Nuernberg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Regensburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Unterhaching
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Wuerzburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Bad Saarow
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Bad Homburg
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Butzbach
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Herborn
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Kassel
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Anklam
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Schwerin
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Wismar
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Achim
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Goettingen
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Goettingen
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Hildesheim
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Wolfsburg
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Bielefeld
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bochum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bochum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bochum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bochum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bochum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Dueren
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Duesseldorf
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Gelsenkirchen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Guetersloh
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Hattingen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Juelich
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Limburgerhof
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Halle
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Koethen
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Oldenburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Gera
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Jena
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: