Table 1.
Baseline characteristics of youth with ASD randomly assigned to Mirtazapine or Placebo.
| Mirtazapine (n = 20) | Placebo (n = 10) | |
|---|---|---|
| Age, Mean (SD) | 10.9 (3.6) | 11.3 (4.1) |
| Male, n (%) | 17 (85%) | 7 (70%) |
| White, n (%)1 | 17 (85%) | 9 (90%) |
| Black or African American, n (%) | 1 (5%) | 1 (10%) |
| Asian, n (%) | 1 (5%) | 0 (0%) |
| Other Race, n (%) | 1 (5%) | 0 (0%) |
| Hispanic or Latino, n (%)2 | 2 (11%) | 2 (20%) |
| DSM-IV Diagnosis, n (%) | ||
| Autistic Disorder | 13 (65%) | 8 (80%) |
| Asperger’s Disorder | 3 (15%) | 1 (10%) |
| PDD NOS | 4 (20%) | 1 (10%) |
| IQ, Mean (SD) | 84.9 (22.5) | 89.6 (23.6) |
| PPVT-4 Score, Mean (SD) | 88.6 (27.5) | 93.1 (22.2) |
| Vineland Adaptive Behavior II Composite Score, Mean (SD) | 73.1 (12.3) | 73.6 (12.5) |
| Clinical Global Impression–Severity subscale, n (%)3 | ||
| 4: Moderately Ill | 7 (35%) | 2 (20%) |
| 5: Markedly Ill | 13 (65%) | 8 (80%) |
| Pediatric Anxiety Rating Scale, 5-Item Total, Mean (SD) | 18.5 (2.9) | 18.1 (2.8) |
| Screen for Childhood Anxiety Related Emotional Disorders, Mean (SD) | 33.5 (13.9) | 28.1 (8.8) |
| Child and Adolescent Symptom Inventory, Anxiety, Mean (SD) | 26.0 (10.3) | 19.7 (6.5) |
| Aberrant Behavior Checklist, Mean (SD) | ||
| I - Irritability | 15.3 (8.2) | 16.4 (9.9) |
| II - Lethargy/Social Withdrawal | 14.9 (8.3) | 6.2 (4.4) |
| III - Stereotypic Behavior | 7.8 (5.7) | 4.4 (4.5) |
| IV - Hyperactivity/Noncompliance | 21.5 (10.7) | 17.5 (13.2) |
| V - Inappropriate Speech | 5.6 (3.8) | 3.7 (2.9) |
| Children’s Sleep Habit Questionnaire, Mean (SD) | 51.2 (9.5) | 47.7 (6.8) |
| Developmental Disability-Child Global Assessment Scale, Mean (SD) | 55.7 (6.1) | 57.7 (6.1) |
1Participants could select more than one race. No participants selected American Indian/Alaskan Native, or Native Hawaiian/Other Pacific Islander.
2Hispanic or Latino ethnicity was missing for two youth.
3No youth were rated 6 (Severely Ill) or 7 (Extremely Ill).
4ASD Autism spectrum disorder; PDD NOS Pervasive developmental disorder not otherwise specified; IQ intelligence quotient; PPVT-4 Peabody Picture Vocabulary Test, Fourth Edition.