Journal Article

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

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

2011

Overview

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.

• Publisher: Springer-Verlag,Springer,Springer Nature B.V
• Subject: Aged / Analysis of Variance / Antidepressants / Biological and medical sciences / Comorbidity / Depressive Disorder - drug therapy / Depressive Disorder - etiology / Dopamine / Dopamine Agonists - therapeutic use / Double-Blind Method / Female / Follow-Up Studies / Humans / Indoles - therapeutic use / Male / Medical sciences / Medicine / Medicine & Public Health / Mental depression / Middle Aged / Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis / Neurology / Neuroradiology / Neurosciences / Original Communication / Psychiatric Status Rating Scales / Restless legs syndrome / Restless Legs Syndrome - complications / Restless Legs Syndrome - drug therapy / Severity of Illness Index / Sleep / Suicides & suicide attempts / Time Factors / Treatment Outcome