The Effects Of Ropinirole On Mood Or Mild Depression In Patients With Moderate To Severe Restless Legs Syndrome
Condition: Restless Legs Syndrome; Moderate to Severe Idiopathic Restless Legs Syndrome (RLS)
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome; Depression
Intervention: Ropinirole
Intervention MeSH terms: Ropinirole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: randomised; ropinirole; depression; RLS; placebo; mood; double-blind; restless legs syndrome; germany

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.

          -  < 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).