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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Ropinirole

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).