Phase 3 N=266 Randomized Triple-blind Treatment

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

Restless Legs Syndrome · Moderate to Severe Idiopathic Restless Legs Syndrome (RLS)

Bottom Line

View on ClinicalTrials.gov: NCT00357097 ↗

Enrolled (actual)

266

Serious AEs

—

Results posted

Sep 2009

Primary outcome: Primary: Average Change of the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score From Baseline to Final Visit After 12 Weeks of Treatment — -10.1; -6.5 Score on a Scale — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ropinirole (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Dec 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Average Change of the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score From Baseline to Final Visit After 12 Weeks of Treatment	-10.1; -6.5	<0.001 sig
SECONDARY 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)	-12.5; -8.8	—
SECONDARY 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	-8.2; -5.5	—
SECONDARY 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	-9.6; -7.2	—
SECONDARY Average Change of the Beck Depression Inventory (BDI) Total Score From Baseline to Final Visit After 12 Weeks of Treatment	-8.6; -6.5	—
SECONDARY 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	-10.9; -9.9	—
SECONDARY Percentage of Participants With at Least Moderate Depression (MADRS Score >= 18) at Baseline and in Week 12	11.7; 23.3	—
SECONDARY Percentage of Participants With at Least Moderate Depression (HAM-D >= 15) at Baseline and in Week 12	10.7; 26.8	—
SECONDARY Percentage of Participants ("Responder") With a Decrease of MADRS Total Score of at Least 6 Points After 12 Weeks Compared to Baseline	74.9; 48.3	—
SECONDARY 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)	80.2; 58.6	—
SECONDARY 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)	-11.6; -7.6	—
SECONDARY 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)	-9.2; -6.5	—
SECONDARY 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)	-10.4; -7.2	—
SECONDARY Change in Average International Restless Legs Scale for Severity (IRLS) Scores in All Participants From Baseline to After 1, 4, and 12 Weeks	-7.7; -4.1; -14.0; -8.6; -14.6; -10.2	—
SECONDARY Percentage of Participants With a Decrease of International Restless Legs Scale (IRLS) Scores of at Least 6 Points After 1, 4 and 12 Weeks	52.6; 28.3; 80.7; 58.3; 84.8; 61.7	—
SECONDARY Percentage of Participants With "Much Improved" or "Very Much Improved" on the Clinical Global Impression-Global Improvement Scale After 1, 4 and 12 Weeks	35.1; 15.0; 66.7; 40.0; 64.3; 46.7	—
SECONDARY Change From Average Baseline Score of Subscale of "Somnolence" in the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks	-12.5; -10.2	—
SECONDARY Change From Average Baseline Scores of Subscale "Sleep Disturbance" of the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks	-30.5; -15.8	—
SECONDARY Change From Average Baseline Scores of Subscale "Sleep Adequacy" of the Medical Outcomes Study Sleep Scale (MOS-SS)to Final Visit After 12 Weeks	34.0; 15.6	—
SECONDARY 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	1.3; 0.5	—

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.
110mmHg or 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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00357097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.