Table 2.
Model-estimated Mean changes from baseline (95% Confidence Intervals) for study outcomes at 10 weeks.
| Mirtazapine (N = 20)1 | ES2 | p | Placebo (N = 10) | ES2 | p | Mirtazapine-Placebo | ES2 | p | |
|---|---|---|---|---|---|---|---|---|---|
| Pediatric Anxiety Rating Scale, 5-Item Total3 | −4.9 (−7.3, −2.6) | 1.76 | <0.001 | −3.2 (−6.5, 0.2) | 1.13 | 0.07 | −1.8 (−5.9, 2.4) | 0.63 | 0.64 |
| Screen for Childhood Anxiety Related Emotional Disorders | −9.7 (−15.4, −4.0) | 0.77 | 0.003 | −5.1 (−12.6, 2.4) | 0.41 | 0.17 | −4.6 (−13.2, 4.1) | 0.36 | 0.29 |
| Child and Adolescent Symptom Inventory Anxiety Items | −9.4 (−14.1, −4.8) | 0.98 | <0.001 | −5.5 (−11.9, 0.8) | 0.58 | 0.09 | −3.9 (−11.6, 3.8) | 0.41 | 0.31 |
| Aberrant Behavior Checklist | |||||||||
| I - Irritability | −3.7 (−7.5, 0.1) | 0.43 | 0.053 | −3.3 (−8.5, 2.0) | 0.38 | 0.21 | −0.5 (−6.9, 6.0) | 0.06 | 0.88 |
| II - Lethargy/Social Withdrawal | −4.9 (−7.6, −2.1) | 0.59 | 0.001 | −2.0 (−5.7, 1.7) | 0.24 | 0.28 | −2.9 (−7.2, 1.5) | 0.35 | 0.19 |
| III - Stereotypic Behavior | −2.8 (−4.3, −1.2) | 0.50 | 0.001 | −1.9 (−4.0, 0.2) | 0.34 | 0.08 | −0.9 (−3.3, 1.5) | 0.16 | 0.46 |
| IV - Hyperactivity/Noncompliance | −5.0 (−8.1, −1.9) | 0.43 | 0.003 | −1.0 (−5.4, 3.3) | 0.09 | 0.62 | −3.9 (−9.3, 1.4) | 0.34 | 0.14 |
| V - Inappropriate Speech | −0.7 (−1.9, 0.5) | 0.19 | 0.26 | −0.5 (−2.1, 1.2) | 0.13 | 0.56 | −0.2 (−2.2, 1.8) | 0.06 | 0.84 |
| Children’s Sleep Habit Questionnaire | −4.3 (−7.1, −1.4) | 0.49 | 0.004 | −3.9 (−7.5, −0.2) | 0.44 | 0.04 | −0.4 (−4.6, 3.8) | 0.05 | 0.85 |
| Developmental Disability-Child Global Assessment Scale | 4.6 (1.9, 7.3) | 0.76 | 0.002 | 1.8 (−1.9, 5.5) | 0.30 | 0.32 | 2.8 (−1.7, 7.4) | 0.46 | 0.21 |
1One participant assigned to mirtazapine who withdrew due to an adverse effect was missing week 6 and week 10 measurements.
2Effect sizes were calculated by dividing the absolute value of the model-estimated mean 10-week change from baseline (mirtazapine and placebo) or the model-estimated mean treatment difference at 10 weeks (mirtazapine-placebo) by the pooled standard deviation at baseline.
3The Pediatric Anxiety Rating Scale (PARS) 5-item total score was a co-primary outcome measure for the study. The corresponding confidence intervals and p-value have been adjusted to reflect a Bonferroni correction accounting for the study’s two co-primary outcomes, the PARS and the Clinical Global Impressions-Improvement subscale.