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

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).