Article Figures & Data
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- Figure 1.
Participant flow diagram.
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Diagnostic Criteria Supportive clinical features of Restless Legs Syndrome Urge to move legs usually accompanied or caused by uncomfortable or unpleasant sensations in the legs (urge to move may not be accompanied by uncomfortable sensations, and arms or other body parts may be involved) Periodic limb movements Urge to move or unpleasant sensation begins or worsens during periods of rest or inactivity Positive family history Urge to move or unpleasant sensation partially or totally relieved by movement (such as walking or stretching) as long as activity continues Response to dopaminergic therapy Urge to move or unpleasant sensation worse in the evening or at night than during the day, or only occurs during the evening or at night; in very severe cases, worsening at night may not be noticeable, but must have been previously present Week 3 Week 6 Completed (n = 49) Not Completed (n = 11) Completed (n = 46) Not Completed (n = 14) Group (% active drug) 46 55 48 50 Female sex (%) 74 91 72 93 Age (years) 51.3 39.5* 52.2 38.8* Baseline scores IRLSSG Total 25.9 26.9 26.0 26.4 BDI (depression) score 14.7 20.9 15.3 17.9 * P < .05 for t test of significant difference between the completion groups.
IRLSSG, International Restless Legs Syndrome Study Group; BDI, Beck Depression Inventory.
Full Sample (N = 60) Active Drug (n = 29) Placebo (n = 31) t/χ2# P Age (years)* 49.3 (13.5) 48.0 (12.9) 50.5 (14.1) −0.69 .491 Female sex (%) 77 76 77 0.02 .887 Baseline IRLSS score* 26.1 (5.3) 26.3 (5.4) 25.9 (5.3) 0.29 .771 Baseline BDI (depression) score* 15.9 (12.8) 16.9 (13.5) 14.9 (12.2) 0.58 .563 * Values presented as mean (SD).
IRLSSG, International Restless Legs Syndrome Study Group; BDI, Beck Depression Inventory.
Active Drug† Placebo† t/χ2# P Week 3 IRLSSG score 15.5 (10.2) 19.9 (7.6) −1.90 .032 IRLSSG difference from baseline 10.8 (10.0) 6.0 (6.6) 2.20 .016 BDI (depression) score 13.9 (11.3) 13.0 (12.6) 0.30 .383 Week 6 IRLSSG score 15.9 (9.1) 18.3 (8.7) −1.04 .152 IRLSSG difference from baseline 10.4 (10.1) 7.6 (7.1) 1.25 .108 BDI (depression) score 13.9 (12.7) 10.4 (11.3) 1.14 .129 * All 60 participants were included in the above intention to treat analyses. For those who dropped out by 3 weeks (n = 11) and by 6 weeks (n = 14), the most recent previous score for that participant on that measure was used.
† Values presented as mean (SD).
IRLSSG, International Restless Legs Syndrome Study Group; BDI, Beck Depression Inventory.
Reason Bupropion Group (n) Placebo Group (n) Chose to withdraw; no medication-related problems 5 4 Miscarriage* 1 0 Nausea 1 2 Irritable mood 0 1 * Participant had denied pregnancy at screening but had miscarriage during study. After this event, we began to require pregnancy testing of all women younger than 55 years of age unless they had had a hysterectomy.
