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Ropinirole improves depressive symptoms and restless legs syndrome severity in RLS patients: a multicentre, randomized, placebo-controlled study.
J Neurol. 2011 Jun; 258(6):1046-54.JN

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.

Authors+Show Affiliations

Somni-Bene Institute for Medical Research and Sleep Medicine, Schwerin, Germany.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

21188406

Citation

Benes, Heike, et al. "Ropinirole Improves Depressive Symptoms and Restless Legs Syndrome Severity in RLS Patients: a Multicentre, Randomized, Placebo-controlled Study." Journal of Neurology, vol. 258, no. 6, 2011, pp. 1046-54.
Benes H, Mattern W, Peglau I, et al. Ropinirole improves depressive symptoms and restless legs syndrome severity in RLS patients: a multicentre, randomized, placebo-controlled study. J Neurol. 2011;258(6):1046-54.
Benes, H., Mattern, W., Peglau, I., Dreykluft, T., Bergmann, L., Hansen, C., Kohnen, R., Banik, N., Schoen, S. W., & Hornyak, M. (2011). Ropinirole improves depressive symptoms and restless legs syndrome severity in RLS patients: a multicentre, randomized, placebo-controlled study. Journal of Neurology, 258(6), 1046-54. https://doi.org/10.1007/s00415-010-5879-7
Benes H, et al. Ropinirole Improves Depressive Symptoms and Restless Legs Syndrome Severity in RLS Patients: a Multicentre, Randomized, Placebo-controlled Study. J Neurol. 2011;258(6):1046-54. PubMed PMID: 21188406.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Ropinirole improves depressive symptoms and restless legs syndrome severity in RLS patients: a multicentre, randomized, placebo-controlled study. AU - Benes,Heike, AU - Mattern,Wolfgang, AU - Peglau,Ines, AU - Dreykluft,Tillmann, AU - Bergmann,Lars, AU - Hansen,Corinna, AU - Kohnen,Ralf, AU - Banik,Norbert, AU - Schoen,S W, AU - Hornyak,Magdolna, Y1 - 2010/12/28/ PY - 2010/09/21/received PY - 2010/12/13/accepted PY - 2010/11/29/revised PY - 2010/12/29/entrez PY - 2010/12/29/pubmed PY - 2011/9/29/medline SP - 1046 EP - 54 JF - Journal of neurology JO - J Neurol VL - 258 IS - 6 N2 - 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. SN - 1432-1459 UR - https://www.unboundmedicine.com/medline/citation/21188406/Ropinirole_improves_depressive_symptoms_and_restless_legs_syndrome_severity_in_RLS_patients:_a_multicentre_randomized_placebo_controlled_study_ L2 - https://dx.doi.org/10.1007/s00415-010-5879-7 DB - PRIME DP - Unbound Medicine ER -