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Epidemiological studies report a 2- to 4-fold risk of a depressive disorder in patients with restless legs syndrome (RLS) compared with healthy controls. The high prevalence rates of depression in RLS indicate an association between the two disorders. Severe sleep disturbance due to the nightly occurrence of RLS symptoms is a common complaint of patients with moderate or severe RLS and may substantially contribute to the emergence of depressive symptoms. Difficulty in the diagnosis of a depressive disorder in patients with RLS may arise from the overlap of symptoms in the two disorders, as sleep-related complaints are frequent both in RLS and depression. The treatment of depression in RLS has some unique aspects, as several antidepressants have been reported to trigger or worsen RLS. To date, no studies have been published regarding the course of depression in untreated and treated patients with RLS. On the other hand, the presence of co-morbid depression can have a substantial impact on the global treatment outcome. In patients with co-morbid moderate/severe depression, antidepressant therapy in parallel with or shortly after commencing RLS treatment is usually necessary. Data from recent trials with dopamine receptor agonists indicate that mild to moderate depressive symptoms are often relieved with improvement of RLS symptoms.

Background Restless legs syndrome (RLS) is a chronic disorder with substantial impact on quality of life similar to that seen in diabetes mellitus or osteoarthritis. Little is known about the psychological characteristics of RLS patients although psychological factors may contribute to unfavourable treatment outcome. Methods In an observational cross-sectional design, we evaluated the psychological features of 166 consecutive RLS patients from three outpatient clinics, by means of the Symptom Checklist 90-R (SCL-90-R) questionnaire. Additionally, the Beck Depression Inventory-II (BDI-II) and the International RLS Severity Scale (IRLS) were measured. Both treated and untreated patients were included, all patients sought treatment. Results Untreated patients (n = 69) had elevated but normal scores on the SCL-90-R Global Severity Index (GSI; p = 0.002) and on the sub-scales somatisation (p < 0.001), compulsivity (p = 0.003), depression (p = 0.02), and anxiety (p = 0.004) compared with a German representative sample. In the treated group, particularly in those patients who were dissatisfied with their actual treatment (n = 62), psychological distress was higher than in the untreated group with elevated scores for the GSI (p = 0.03) and the sub-scales compulsivity (p = 0.006), depression (p = 0.012), anxiety (p = 0.031), hostility (p = 0.013), phobic anxiety (p = 0.024), and paranoid ideation (p = 0.012). Augmentation, the most serious side effect of dopaminergic, i.e. first-line treatment of RLS, and loss of efficacy were accompanied with the highest psychological distress, as seen particularly in the normative values of the sub-scales compulsivity and anxiety. Generally, higher RLS severity was correlated with higher psychological impairment (p < 0.001). Conclusion Severely affected RLS patients show psychological impairment in multiple psychological domains which has to be taken into account in the treatment regimen.

The European Restless Legs Syndrome (RLS) Study Group performed the first multi-center, long-term study systematically evaluating RLS augmentation under levodopa treatment. This prospective, open-label 6-month study was conducted in six European countries and included 65 patients (85% treatment naive) with idiopathic RLS. Levodopa was flexibly up-titrated to a maximum dose of 600 mg/day. Presence of augmentation was diagnosed independently by two international experts using established criteria. In addition to the augmentation severity rating scale (ASRS), changes in RLS severity (International RLS severity rating scale (IRLS), clinical global impression (CGI)) were analyzed. Sixty patients provided evaluable data, 35 completed the trial and 25 dropped out. Augmentation occurred in 60% (36/60) of patients, causing 11.7% (7/60) to drop out. Median time to occurrence of augmentation was 71 days. The mean maximum dose of levodopa was 311 mg/day (SD: 105). Patients with augmentation compared to those without were significantly more likely to be on higher doses of levodopa (≥300 mg, 83 vs. 54%, P  = 0.03) and to show less improvement of symptom severity (IRLS, P  = 0.039). Augmentation was common with levodopa, but could be tolerated by most patients during this 6-month trial. Patients should be followed over longer periods to determine if dropout rates increase with time.

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.

Background:Restless legs syndrome (RLS) is a usually chronic disorder accompanied by clinically relevant psychosocial impairment. To date, no psychologically based approach is available to improve the coping strategies and quality of life of RLS sufferers.Objective:To develop cognitive behavioural therapy tailored to this disorder (the RELEGS coping therapy programme) and present the results of this proof-of-concept study.Methods:Twenty-five patients (five men, 20 women; 15 medicated, 10 unmedicated; mean (SD) age 56.1 (12.3) years) with subjective psychosocial impairment due to RLS participated in one of three consecutive therapy groups. The severity scales (IRLS and RLS-6) indicated moderate to severe RLS symptoms at baseline. Exclusion criteria were secondary RLS, foreseeable change of RLS medication during the study period, serious physical or psychiatric comorbidity, and severe cognitive deficits. Each group took part in eight group sessions (90 min each with a break).Results:At the end of the treatment, both the RLS-related quality of life and the mental health status of the subjects had improved significantly (QoL-RLS scale: from 28.6 (12.8) to 23.4 (13.1); SCL-90-R: from 51.3 (37.0) to 45.9 (32.9)). The improvement remained at follow-up 3 months later. Subjective ratings of RLS severity had improved at the end of therapy and at follow-up. Psychometric scales not specific for RLS-related impairment remained unaffected by the treatment.Conclusions:The study establishes the feasibility and high acceptance of the newly devised therapy programme. The application of RLS-oriented specific psychological strategies is a step toward an integrated treatment approach in RLS.

Summary We have developed and validated the Munich Parasomnia Screening (MUPS) questionnaire, a self-rating instrument with 21 items assessing the lifetime prevalence and current frequency of parasomnias and nocturnal behaviors in adult persons. The MUPS was developed with psychiatric patients (total n = 74). For the validation study the MUPS was given to three large groups, i.e. psychiatric patients (n = 65), sleep-disordered patients (n = 50), and healthy controls (n = 65). In a randomly chosen subset of 20 % of these subjects the MUPS was compared to the information obtained in a detailed clinical interview with a sleep medicine expert. Validity was assessed for lifetime prevalence of any frequency for each of the 21 nocturnal behaviors. For the individual items of the MUPS sensitivity was equal to or above 90 % for all but two of 21 items and specificity was above 80 % for all items and above 90 % for 19 of 21 items. More importantly, concerning the use of the MUPS in clinical practice, positive and negative predictive values of the single items were high for the majority of items. The MUPS appears to be an easy to use and valid instrument in the recognition of nocturnal behaviors and parasomnias.

Summary Question of the study  As sedating antidepressants have been used increasingly in the treatment of insomnia, the question whether they elicit periodic leg movements in sleep (PLMS) and thereby disturb sleep patterns may be clinically relevant. PLMS are generally supposed to play a role in eliciting and maintaining sleep disturbances in patients with otherwise unexplained insomnia or daytime sleepiness. We evaluated the PLMS data from a double‐blind, placebo‐controlled polysomnographic treatment study with doxepin in patients with primary insomnia. The aim of the study was to investigate the influence of low‐dose doxepin on PLMS. Patients and methods  PLMS recordings from the first diagnostic nights were scored in all 40 patients. PLMS scores from each of the 10 polysomnographic (PSG) nights were however available only in a subset of subjects, because PLMS data were originally not considered as a study objective. The PLMS data of 13 patients over 10 nights (2 baseline nights, 3 treatment nights, 3 withdrawal nights, 2 follow‐up nights) were assessed. Patients were treated either with doxepin (six patients 50 mg, one patient 25 mg) or with placebo (six patients) 1 h prior to bed time. Results  Comparing the doxepin and the placebo group for the different days of the study, we found no significant differences in PLMS parameters. In the doxepin group, the discontinuation of doxepin was however associated with a significant (P < 0.05) decrease in the PLMS–arousal index (PLMS associated with arousal per hour of sleep), indicating a possible relationship between doxepin medication and the presence of PLMS. Conclusions  Treatment with low‐dose doxepin appears to exert only a weak influence on PLMS in patients with primary insomnia. Zusammenfassung Fragestellung  Sedierende Antidepressiva werden zunehmend in der Behandlung der Insomnien eingesetzt. Die Frage, ob sedierende Antidepressiva die Anzahl der PLMS erhöhen gewinnt daher an klinischer Relevanz, da PLMS zur Entstehung bzw. Aufrechterhaltung von Insomnien beitragen können. In der vorliegenden Untersuchung haben wir die PLMS‐Daten einer bereits publizierten doppel‐blinden plazebo‐kontrollierten polysomnographischen (PSG) Behandlungsstudie mit niedrig‐dosiertem Doxepin bei Patienten mit primärer Insomnie ausgewertet. Ziel der retrospektiven Auswertung war es, den Einfluss von niedrig‐dosiertem Doxepin auf die Anzahl der PLMS zu untersuchen. Patienten und Methodik  Die PLMS‐Daten aller PSG‐Untersuchungsnächte waren bei 13 Patienten vorhanden. Eine PLMS‐Diagnostik wurde in der ersten (Adaptations‐) Nacht zwar bei allen Patienten durchgeführt, PLMS‐Ableitungen in den weiteren Nächten wurden jedoch nur bei einer kleinen Anzahl der Patienten vorgenommen. Die PSG‐Untersuchungen erfolgten 2 Nächte vor Behandlung, in den ersten und den letzten 2 Nächten der Behandlungsperiode, in den ersten 3 Absetz‐Nächten sowie in den letzten 2 Nächten der Untersuchung (41. und 42. Nacht). Die Patienten erhielten entweder Doxepin (6 Patienten 50 mg, ein Patient 25 mg) oder Plazebo (6 Patienten), jeweils 1 Stunde vor dem Schlafengehen. Ergebnisse  Die PLMS‐Parameter zeigten keine Unterschiede beim Vergleich beider Gruppen. Das Absetzen von Doxepin war in der Verum‐Guppe jedoch mit einer signifikanten Abnahme (P < 0,05) des PLMS‐Arousal Index (PLMS‐assoziierte Arousals pro Stunde Schlaf) verbunden. Schlussfolgerung  Die Abnahme des PLMS‐Arousal Index nach Absetzen von Doxepin weist auf einen möglichen, allerdings schwachen, Einfluss von Doxepin auf die PLMS in Patienten mit primärer Insomnie hin.

SummaryWe have developed and validated the Munich Parasomnia Screening (MUPS) questionnaire, a self-rating instrument with 21 items assessing the lifetime prevalence and current frequency of parasomnias and nocturnal behaviors in adult persons. The MUPS was developed with psychiatric patients (total n = 74). For the validation study the MUPS was given to three large groups, i.e. psychiatric patients (n = 65), sleep-disordered patients (n = 50), and healthy controls (n = 65). In a randomly chosen subset of 20 % of these subjects the MUPS was compared to the information obtained in a detailed clinical interview with a sleep medicine expert. Validity was assessed for lifetime prevalence of any frequency for each of the 21 nocturnal behaviors. For the individual items of the MUPS sensitivity was equal to or above 90 % for all but two of 21 items and specificity was above 80 % for all items and above 90 % for 19 of 21 items. More importantly, concerning the use of the MUPS in clinical practice, positive and negative predictive values of the single items were high for the majority of items. The MUPS appears to be an easy to use and valid instrument in the recognition of nocturnal behaviors and parasomnias.