Three- and Six-Week Outcomes by Study Group Assignment*
| 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.