Randomized trial of pramipexole for patients with restless legs syndrome (RLS) and RLS-related impairment of mood.
OBJECTIVE
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.


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.


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%).


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.
Dipartimento di Scienze Neurologiche, Università degli Studi di Bologna, Bologna, Italy.
Pasquale
P
Montagna
Magdolna
M
Hornyak
Jan
J
Ulfberg
Seung Bong
SB
Hong
Juergen
J
Koester
Giovanna
G
Crespi
Stefan
S
Albrecht
D000339:Affect / Q000187:drug effects; D052160:Benzothiazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D018491:Dopamine Agonists / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019964:Mood Disorders / Q000188:drug therapy* / Q000209:etiology; D000077487:Pramipexole; D011569:Psychiatric Status Rating Scales; D012148:Restless Legs Syndrome / Q000150:complications / Q000188:drug therapy* / Q000523:psychology; D016896:Treatment Outcome
D052160:Benzothiazoles; D018491:Dopamine Agonists; D000077487:Pramipexole