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

Journal of Neurology

Volumn 258, Issue 6, 2011, Pages 1046-1054

  Benes, Heike ^a   Mattern, Wolfgang ^b   Peglau, Ines ^b   Dreykluft, Tillmann ^c   Bergmann, Lars ^d   Hansen, Corinna ^d   Kohnen, Ralf ^e,f   Banik, Norbert ^d   Schoen, S W ^d   Hornyak, Magdolna ^g  

^a Somni Bene Institute for Medical Research and Sleep Medicine   (Germany)

^b Klinische Forschung Berlin ^*

^c RPS   (United Kingdom)

^d GLAXOSMITHKLINE   (Germany)

^e Qualcomm Germany GmbH   (Germany)

^f UNIVERSITY OF ERLANGEN NUREMBERG   (Germany)

^g UNIVERSITY OF FREIBURG   (Germany)

Author keywords

Depressive symptoms; RCT; Restless legs syndrome; Ropinirole; Treatment

Indexed keywords

PLACEBO; ROPINIROLE;

ABDOMINAL PAIN; ADULT; AGED; ARTICLE; BECK DEPRESSION INVENTORY; BEDTIME DOSAGE; CLINICAL GLOBAL IMPRESSION SCALE; COMORBIDITY; CONTROLLED STUDY; DEPRESSION; DIARRHEA; DISEASE SEVERITY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG OVERDOSE; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; FEMALE; HAMILTON SCALE; HEADACHE; HUMAN; HYPERHIDROSIS; INTENTION TO TREAT ANALYSIS; INTERNATIONAL RESTLESS LEGS STUDY GROUP RATING SCALE; MAJOR CLINICAL STUDY; MALE; MEDICAL OUTCOMES STUDY SLEEP SCALE; MONTGOMERY ASBERG DEPRESSION RATING SCALE; MULTICENTER STUDY; NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; NAUSEA; OUTCOME ASSESSMENT; PERIPHERAL EDEMA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESTLESS LEGS SYNDROME; SCORING SYSTEM; TREATMENT DURATION; VOMITING;

EID: 79959813151     PISSN: 03405354     EISSN: 14321459     Source Type: Journal    
DOI: 10.1007/s00415-010-5879-7     Document Type: Article

References (33)

1. RP Allen D Picchietti WA Hening, et al. 2003 Restless legs syndrome: diagnostic criteria, special considerations and epidemiology. A report from the restless legs syndrome diagnosis and epidemiology workshop at the National Institute of Health Sleep Med 4 101 119 14592341 10.1016/S1389-9457(03)00010-8 (Pubitemid 36527231)
2. K Berger T Kurth 2007 RLS epidemiology-frequencies, risk factors and methods in population studies Mov Disord 22 suppl18 S420 S423 17557345 10.1002/mds.21589
3. L Abetz R Allen A Follet, et al. 2004 Evaluating the quality of life of patients with restless legs syndrome Clin Ther 26 925 935 15262463 10.1016/S0149-2918(04)90136-1 (Pubitemid 38943041)
4. RP Allen AS Walters J Montplaisir, et al. 2005 Restless legs syndrome prevalence and impact: REST general population study Arch Intern Med 165 1286 1292 15956009 10.1001/archinte.165.11.1286 (Pubitemid 40989594)
5. S Happe JP Reese K Stiasny-Kolster, et al. 2009 Assessing health-related quality of life in patients with restless legs syndrome Sleep Med 10 3 295 305 18359664 10.1016/j.sleep.2008.01.002
6. M Vandeputte A deWeerd 2003 Sleep disorders and depressive feelings: a global survey with the Beck depression scale Sleep Med 4 343 345 14592308 10.1016/S1389-9457(03)00059-5 (Pubitemid 36974815)
7. J Ulfberg B Nyström N Carter, et al. 2001 Prevalence of restless legs syndrome among men aged 18-64 years: an association with somatic disease and neuropsychiatric symptoms Mov Disord 16 1159 1163 11748753 10.1002/mds.1209 1:STN:280:DC%2BD3MnpvFCgsw%3D%3D (Pubitemid 36041234)
8. J Winkelmann M Prager R Lieb, et al. 2005 "Anxietas Tibiarum" depression and anxiety disorders in patients with restless legs syndrome J Neurol 252 67 71 15654556 10.1007/s00415-005-0604-7 1:STN:280: DC%2BD2M%2FislWisw%3D%3D (Pubitemid 40179020)
9. HB Lee WA Hening RP Allen, et al. 2008 Restless legs syndrome is associated with DSM-IV major depressive disorder and panic disorder in the community J Neuropsychiatry Clin Neurosci 20 101 105 18305292 10.1176/appi.neuropsych.20.1.101 (Pubitemid 351295036)
10. W Katon EH Lin K Kroenke 2007 The association of depression and anxiety with medical symptom burden in patients with chronic medical illness Gen Hosp Psychiatry 29 2 147 155 17336664 10.1016/j.genhosppsych.2006.11.005
11. M Hornyak M Kopasz M Berger, et al. 2005 Impact of sleep-related complaints on depressive symptoms in patients with restless legs syndrome J Clin Psychiatry 66 1139 1145 16187772 10.4088/JCP.v66n0909 (Pubitemid 41442281)
12. KG Rottach BM Schaner MH Kirch, et al. 2008 Restless legs syndrome as side effect of second generation antidepressants J Psychiatry Res 43 70 75 10.1016/j.jpsychires.2008.02.006
13. D Picchietti JD Winkelmann 2005 Restless legs syndrome, periodic limb movements in sleep, and depression Sleep 28 891 898 16124671 (Pubitemid 40993722)
14. S Cohrs A Rodenbeck M Hornyak D Kunz 2008 Restless legs syndrome, periodic limb movements and psychopharmacology Nervenarzt 79 11 1263 1272 18958441 10.1007/s00115-008-2575-2 1:STN:280:DC%2BD1cjjtVartw%3D%3D
15. L Vignatelli M Billiard P Clarenbach, et al. 2006 EFNS task force. EFNS guidelines on management of restless legs syndrome and periodic limb movement disorder in sleep Eur J Neurol 13 1049 1065 16987157 10.1111/j.1468-1331.2006. 01410.x 1:STN:280:DC%2BD28rmt1SgsA%3D%3D (Pubitemid 44434310)
16. WH Oertel C Trenkwalder M Zucconi, et al. 2007 State of the art in restless legs syndrome therapy: practice recommendations for treating restless legs syndrome Mov Disord 22 suppl18 S466 S475 17516455 10.1002/mds.21545
17. C Trenkwalder WA Hening P Montagna, et al. 2008 Treatment of restless legs syndrome: an evidence-based review and implications for clinical practice Mov Disord 23 16 2267 2302 18925578 10.1002/mds.22254
18. C Trenkwalder D Garcia -Borreguero P Montagna On behalf of the TREAT RLS 1 (Therapy with Ropinirole; Efficacy And Tolerability in RLS 1) study group, et al. 2004 Ropinirole in the treatment of restless legs syndrome: results from the TREAT RLS 1 study, a 12 week, randomised, placebo controlled study in 10 European countries J Neurol Neurosurg Psychiatry 75 92 97 14707315 1:STN:280:DC%2BD2c%2FjvVSguw%3D%3D (Pubitemid 38091275)
19. A Walters W Ondo T Dreykluft On behalf of the TREAT RLS 2 (Therapy with Ropinirole: Efficacy And Tolerability in RLS 2) study group, et al. 2004 Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2: a 12-week, double-blind, randomized, parallel-group, placebo-controlled study Mov Disord 19 12 1414 1423 15390050 10.1002/mds.20257 (Pubitemid 40104048)
20. R Allen PM Becker R Bogan, et al. 2004 Ropinirole decreases periodic leg movements and improves sleep parameters in patients with restless legs syndrome Sleep 27 5 907 914 15453549 (Pubitemid 39095723)
21. RK Bogan JM Fry MH Schmidt For the TREAT RLS US (Therapy with ropinirole And Efficacy, Tolerability in RLS US) study group, et al. 2006 Ropinirole in the treatment of patients with restless legs syndrome: a US-based randomized, double-blind, placebo-controlled clinical trial Mayo Clin Proc 81 17 27 16438474 10.4065/81.1.17 1:CAS:528:DC%2BD28XntVCisA%3D%3D (Pubitemid 43054313)
22. G Perugi C Toni G Ruffolo, et al. 2001 Adjunctive dopamine agonists in treatment-resistant bipolar II depression: an open case series Pharmacopsychiatry 34 4 137 141 11518474 10.1055/s-2001-15872 1:CAS:528:DC%2BD3MXmt1agu70%3D (Pubitemid 32701763)
23. P Cassano L Lattanzi M Fava, et al. 2005 Ropinirole in treatment-resistant depression: a 16-week pilot study Can J Psychiatry 50 6 357 360 15999953 (Pubitemid 43175517)
24. H Benes R Kohnen 2009 Validation of an algorithm for the diagnosis of Restless Legs Syndrome: The Restless Legs Syndrome-Diagnostic Index (RLS-DI) Sleep Med 10 5 515 523 18823819 10.1016/j.sleep.2008.06.006
25. A Walters The International Restless Legs Syndrome Study Group 2003 Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs syndrome Sleep Med 4 121 132 14592342 10.1016/S1389-9457(02) 00258-7 (Pubitemid 36527232)
26. SA Montgomery M Asberg 1979 A new depression rating scale designed to be sensitive to change Brit J Psychiatry 134 382 389 10.1192/bjp.134.4.382 1:STN:280:DyaE1M7ovVCksg%3D%3D (Pubitemid 9136500)
27. DV Sheehan Y Lecrubier KH Sheehan, et al. 1998 The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10 J Clin Psychiatry 59 suppl 20 22 33 9881538 (Pubitemid 29001829)
28. M Zimmerman MA Posternak I Chelminski 2004 Defining remission on the Montgomery-Asberg depression rating scale J Clin Psychiatry 65 2 63 68 10.4088/JCP.v65n0204
29. R Uher A Farmer W Maier, et al. 2008 Measuring depression: comparison and integration of three scales in the GENDEP study Psychol Med 38 289 300 17922940 10.1017/S0033291707001730 1:STN:280:DC%2BD1c%2FlsFGktg%3D%3D (Pubitemid 351156595)
30. Beck AT, Steer RA, Brown GK (1996) Manual for the Beck depression inventory-II. Psychological corporation, San Antonio
31. E Frank RF Prien RB Jarrett, et al. 1991 Conceptualization and rationale for consensus definitions of terms in major depressive disorder. Remission, recovery, relapse, and recurrence Arch Gen Psychiatry 48 851 855 1929776 1:STN:280:DyaK38%2FivVamsQ%3D%3D
32. RD Hays SA Martin AM Sesti, et al. 2005 Psychometric properties of the medical outcomes study sleep measure Sleep Med 6 41 44 15680294 10.1016/j.sleep.2004.07.006
33. M Hornyak H Benes I Eisensehr J Haan J Kassubek I Peglau K Stiasny-Kolster C Trenkwalder 2009 Depression in restless legs syndrome, pathogenesis, assessment, and implications for treatment Nervenarzt 80 10 1160 1168 19360385 10.1007/s00115-009-2710-8 1:STN:280:DC%2BD1MnovF2ntQ%3D%3D