Table 2.
Effect of Guanfacine Treatment on Primary and Secondary Outcomes
Outcome Measure | Placebo (n=40) | 0.1 mg (n=40) | 0.5 mg (n=39) |
---|---|---|---|
Prefrontal Executive Function (PEF6 z-score) | |||
Unadjusted Baseline | 0.039 | −0.084 | 0.102 |
Unadjusted Week 12 | 0.305 | 0.053 | 0.303 |
Unadjusted Change | 0.266 | 0.137 | 0.201 |
Adjusted Change | 0.270 | 0.121 | 0.213 |
95% confidence interval | 0.159, 0.380 | 0.011, 0.232 | 0.101, 0.324 |
p-Value* | –––– | 0.06 | 0.47 |
Quality of Life (SF-36-MCS) | |||
Unadjusted Baseline | 55.878 | 56.617 | 55.462 |
Unadjusted Week 12 | 55.985 | 55.677 | 54.638 |
Unadjusted Change | 0.107 | −0.940 | −0.824 |
Adjusted Change | −0.083 | −0.618 | −0.960 |
95% confidence interval | −1.725, 1.559 | −2.253, 1.017 | −2.614, 0.694 |
p-Value* | –––– | 0.65 | 0.46 |
Global Function (ADCS-CGIC) | |||
Worsened (%) | 3 (7.5) | 4 (10.0) | 2 (5.1) |
No Change (%) | 25 (62.5) | 20 (50.0) | 22 (56.4) |
Improved (%) | 12 (30.0) | 16 (40.0) | 15 (38.5) |
Odds Ratio | –––– | 1.43 | 1.46 |
p-Value** | –––– | 0.67 | 0.60 |
Notes: PEF6 z-score = the mean of z-scores for 6 executive function tasks (CANTAB: Spatial Working Memory, Stockings of Cambridge, Intradimensiona/Extradimensional Shift, Paired Associates Learning; Stroop Color Word Score, Trail Making Test B); SF-36-MCS = Mental Component Score of the 36-Item Short-Form Health Survey (higher scores represent better mental health); ADCS-CGIC scores are for Week 12 compared to baseline. The seven-point scale was collapsed to 3 groups: improved (1–3), no-change (4), and worsening (5–7).
p-Values for regression coefficients representing the differences in least squares means between each dosing group and the placebo group. A multivariable linear regression model was employed, whose main predictor was medication treatment group, and whose covariates included baseline score, age, sex, and education.
p-Values for regression coefficients representing log odds ratios for each dosing group as compared to the placebo group. A multivariable proportional odds model was employed, whose main predictor is medication treatment group, and whose covariates include age, sex, and education.