Table 3.
Baseline | Week 1 | Month 1 | Month 3 | Month 5 | Month 6 | Placebo Run-out | |
---|---|---|---|---|---|---|---|
Morning alertness | |||||||
Placebo | 4.09 | 3.88 | 3.90 | 3.75 | 3.80 | 3.70 | 3.67 |
Ramelteon | 4.12 | 4.00 | 3.86 | 3.79 | 3.79 | 3.78 | 3.67 |
Ability to concentrate | |||||||
Placebo | 4.10 | 3.89 | 3.96 | 3.79 | 3.85 | 3.75 | 3.67 |
Ramelteon | 4.15 | 3.95 | 3.83 | 3.73 | 3.77 | 3.79 | 3.67 |
DSST | |||||||
Placebo | 36.00 | 38.31 | 40.51 | 38.36 | 40.27 | 41.72 | 41.49 |
Ramelteon | 35.27 | 38.08 | 40.48 | 39.29 | 40.77 | 41.53 | 42.27 |
Immediate memory recall | |||||||
Placebo | 6.78 | 8.13 | 7.60 | 8.98 | 8.81 | 8.46 | 8.43 |
Ramelteon | 6.89 | 8.11 | 7.50 | 9.12 | 8.67 | 8.36 | 8.09 |
Delayed memory recall | |||||||
Placebo | 4.87 | 6.44 | 6.30 | 7.79 | 7.45 | 7.42 | 6.95 |
Ramelteon | 5.04 | 6.41 | 6.32 | 7.92 | 7.46 | 7.24 | 6.52 |
VAS for feelings – energetic/fatigued | |||||||
Placebo | 47.99 | 42.53 | 41.77 | 40.72 | 39.08 | 39.22 | 38.14 |
Ramelteon | 47.83 | 44.67 | 42.66 | 39.45 | 40.93 | 43.26a | 42.22a |
VAS for mood - drowsy | |||||||
Placebo | 36.06 | 31.11 | 30.22 | 29.61 | 30.62 | 28.65 | 27.76 |
Ramelteon | 35.22 | 34.46a | 31.96 | 29.69 | 30.24 | 30.69 | 28.86 |
VAS for mood – slowed down | |||||||
Placebo | 34.43 | 30.12 | 28.87 | 29.11 | 29.28 | 28.11 | 26.25 |
Ramelteon | 33.85 | 33.27a | 30.87 | 28.78 | 29.88 | 30.41 | 28.42 |
VAS for mood - sleepy | |||||||
Placebo | 37.86 | 33.17 | 31.78 | 30.41 | 31.23 | 30.12 | 28.62 |
Ramelteon | 37.68 | 36.42a | 33.08 | 31.12 | 31.58 | 31.94 | 29.48 |
VAS for feelings – thinking slowed down/speeded up | |||||||
Placebo | 39.08 | 39.91 | 38.88 | 39.25 | 39.28 | 40.90 | 40.79 |
Ramelteon | 39.31 | 38.39 | 40.59 | 40.58 | 39.46 | 37.34a | 37.94 |
Data are reported as least-square mean. The number of subjects was 224 in the Placebo group and 227 in the Ramelteon group. The number for each time point may be slightly less in either group due to available data. DSST refers to Digit Symbol Substitution Test.
Subjective morning alertness and ability to concentrate are evaluated on a 7-point scale in which 1 = excellent and 7 = extremely poor. Visual analog scale (VAS) for Feelings: 0 = energetic, 100 = fatigued; VAS for Mood: 0 = a little, 100 = a lot;
P < 0.05 vs placebo (obtained using t-tests from the analysis of covariance model of the overall treatment comparison).