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 no therapy to know whether a drug could improve both depressive and RLS symptoms.

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).