Evidence map›Paper›PMID 21188406›Full record

Trial reportJournal of neurology2011

Ropinirole improves depressive symptoms and restless legs syndrome severity in RLS patients: a multicentre, randomized, placebo-controlled study.

Heike Benes, Wolfgang Mattern, Ines Peglau, Tillmann Dreykluft, Lars Bergmann, Corinna Hansen, Ralf Kohnen, Norbert Banik, S W Schoen, Magdolna Hornyak

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of neurology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 3 pooled it
2.8field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 3 syntheses or guidelines pooled it, 55 citations in OpenAlex.

  1. Treatment of restless legs syndrome and periodic limb movement disorder: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025
    Pooled it
  2. Pooled it
  3. Dopamine agonists for restless legs syndrome.The Cochrane database of systematic reviews · 2011
    Pooled it
  4. Efficacy of an eight-week yoga intervention on symptoms of restless legs syndrome (RLS): a pilot study.Journal of alternative and complementary medicine (New York, N.Y.) · 2013
    Trial
  5. Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. Sleep therapeutics and neuropsychiatric illness.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2020
    Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. The link between sleep disturbance and depression among Mexican Americans: a Project FRONTIER study.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2014
    Article
  17. Article
  18. Article
  19. Article
  20. Psychiatric comorbidity in children and adolescents with restless legs syndrome: a retrospective study.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2011
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 1 country.

Heike BenesSomni-Bene Institute for Medical Research and Sleep Medicine, Schwerin, Germany.
Wolfgang Mattern
Ines Peglau
Tillmann Dreykluft
Lars Bergmann
Corinna Hansen
Ralf Kohnen
Norbert Banik
S W Schoen
Magdolna Hornyak
GlaxoSmithKline (Germany) · DEFriedrich-Alexander-Universität Erlangen-Nürnberg · DEGesellschaft für Klinische Forschung · DEHelios Hospital Schwerin · DEUniversity Medical Center Freiburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Comorbid depressive symptoms in restless legs syndrome (RLS) remain a treatment challenge, as some antidepressants aggravate RLS symptoms. Preliminary data in depressive patients suggest antidepressant properties of ropinirole. The present study investigates the effects of ropinirole immediate release (IR) on depressive symptoms and RLS severity. A multicenter, placebo-controlled, double-blind randomized (3:1) study was performed including patients with moderate to severe idiopathic RLS and at least mild depressive symptoms. Ropinirole IR (in flexible doses up to 4 mg/day) or placebo was given for 12 weeks including an uptitration phase of 7 weeks. Visits were scheduled at screening, baseline, and weeks 1, 4, and 12 with additional telephone contacts for dosing decisions. The modified intent to treat population comprised 231 patients (171 ropinirole, 60 placebo). The MADRS (Montgomery-Asberg Depression Rating Scale) scores decreased from baseline to week 12 from 18.8 to 8.7 in the ropinirole group and from 18.4 to 12.1 in the placebo group (primary endpoint, adjusted mean treatment difference -3.6 (95% CI: -5.6 to -1.6, significance in favor of ropinirole: P < 0.001). The superiority of ropinirole compared to placebo was confirmed by the Hamilton Scale for Depression and Beck Depression Inventory-II scores. RLS severity scores (IRLS) decreased by 14.7 (ropinirole) and by 9.9 (placebo, P < 0.001) points. Three out of four subdomains of the Medical Outcomes Study Sleep Scale improved significantly. The findings indicate that mild to moderate depressive symptoms should not be treated before sufficient therapy for RLS. Antidepressant medication can be necessary if depression symptoms still persist even if RLS symptoms are ameliorated.

Indexed as

AgedAnalysis of VarianceDepressive DisorderDopamine AgonistsDouble-Blind MethodFemaleFollow-Up StudiesHumansIndolesMaleMiddle AgedPsychiatric Status Rating ScalesRestless Legs SyndromeSeverity of Illness IndexTime FactorsTreatment OutcomeDopamine AgonistsIndolesropinirole

Identifiers

PMID21188406
OpenAlexW2081152911

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.