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Randomized trial of pramipexole for patients with restless legs syndrome (RLS) and RLS-related impairment of mood.
- Source :
-
Sleep medicine [Sleep Med] 2011 Jan; Vol. 12 (1), pp. 34-40. Date of Electronic Publication: 2010 Oct 20. - Publication Year :
- 2011
-
Abstract
- Objectives: Patients with restless legs syndrome (RLS) have an elevated prevalence of mood disorders compared with the general population. We investigated the change of RLS-related mood impairment during treatment of RLS with pramipexole, a dopamine D(3)/D(2) agonist.<br />Methods: Adults with moderate to very severe RLS were enrolled in a 12-week, double-blind, placebo-controlled Phase IV pramipexole trial. A moderate to very severe RLS-related mood disturbance at baseline (score ≥2 on Item 10 of the International RLS Study Group Rating Scale [IRLS]) was also required. Pramipexole (0.125 to 0.75 mg once daily) was flexibly titrated over the first 4 weeks.<br />Results: The intent-to-treat population comprised 199 patients on placebo and 203 on pramipexole. At week 12, adjusted mean total-score changes on IRLS were -14.2±0.7 for pramipexole and -8.1±0.7 for placebo (p<0.0001), and on the Beck Depression Inventory version II, -7.3±0.4 for pramipexole and -5.8±0.5 for placebo (p=0.0199). For IRLS item 10, the 12-week responder rate (reduction to no or mild mood disturbance) was 75.9% for pramipexole and 57.3% for placebo (p<0.0001). Study withdrawal rates were higher for placebo (20.5%) than for pramipexole (12.8%).<br />Conclusions: In patients with RLS-related mood disturbance, pramipexole improved RLS while also improving RLS-related mood impairment. Tolerability of pramipexole was similar to that in previous studies.<br /> (Copyright © 2010 Elsevier B.V. All rights reserved.)
- Subjects :
- Affect drug effects
Benzothiazoles administration & dosage
Dopamine Agonists administration & dosage
Double-Blind Method
Female
Humans
Male
Middle Aged
Mood Disorders etiology
Pramipexole
Psychiatric Status Rating Scales
Restless Legs Syndrome complications
Restless Legs Syndrome psychology
Treatment Outcome
Benzothiazoles therapeutic use
Dopamine Agonists therapeutic use
Mood Disorders drug therapy
Restless Legs Syndrome drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1878-5506
- Volume :
- 12
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Sleep medicine
- Publication Type :
- Academic Journal
- Accession number :
- 20965780
- Full Text :
- https://doi.org/10.1016/j.sleep.2010.08.005