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The Effects Of Ropinirole On ...

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

Last Updated: 2012-06-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Restless Legs Syndrome Moderate to Severe Idiopathic Restless Legs Syndrome (RLS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Interventions

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Ropinirole

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers