The Effects Of Ropinirole On Mood Or Mild Depression In Patients With Moderate To Severe Restless… (NCT00357097) | Clinical Trial Compass
CompletedPhase 3
The Effects Of Ropinirole On Mood Or Mild Depression In Patients With Moderate To Severe Restless Legs Syndrome
Germany240 participantsStarted 2006-06
Plain-language 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.
Who can participate
Age range18 Years – 79 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Average Change of the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score From Baseline to Final Visit After 12 Weeks of Treatment