Table 2.
Comparison across groups of mean change from baseline to week 12
| Measure | Variable name | Number of subjects placebo | Mean change placebo | Median change placebo | Number of subjects oxytocin | Mean change oxytocin | Median change oxytocin | Mann–Whitney U test statistic | Two-sided p-value |
|---|---|---|---|---|---|---|---|---|---|
| ABC | |||||||||
| Irritability | 9 | − 5 | − 3 | 7 | − 1.71 | 0 | 40.5 | 0.351 | |
| Social withdrawal | 9 | − 7.44 | − 7 | 7 | − 2.42 | − 3 | 50 | 0.055 | |
| Stereotypy | 9 | − 2.22 | − 1 | 7 | 0.57 | 0 | 41.5 | 0.299 | |
| Hyperactivity | 9 | − 8.11 | − 6 | 7 | − 2.71 | 0 | 42 | 0.299 | |
| Inappropriate speech | 9 | − 1.67 | 0 | 7 | − 7.14 | 0 | 35 | 0.758 | |
| RBS-R | |||||||||
| Stereotypic behaviors | 9 | − 1.67 | − 2 | 7 | 0.29 | 0 | 43 | 0.252 | |
| Self-injury | 9 | − 1.22 | 0 | 7 | 1 | 0 | 46 | 0.142 | |
| Compulsive behaviors | 9 | − 1.56 | 0 | 7 | − 0.14 | 0 | 38 | 0.536 | |
| Ritualistic behaviors | 9 | − 1.33 | − 1 | 7 | − 0.43 | 0 | 39 | 0.47 | |
| Sameness behaviors | 9 | − 2 | − 1 | 7 | − 0.29 | − 1 | 41 | 0.351 | |
| Restricted behaviors | 9 | − 1.43 | 0 | 7 | 0.14 | 0 | 23.5 | 0.902 | |
| Overall score | 9 | − 8.56 | − 3 | 7 | 0 | 0 | 46 | 0.142 | |
| CGI-I | |||||||||
| Severity | 9 | − 0.11 | 0 | 7 | − 0.14 | 0 | 30.5 | 0.918 | |
| Improvement* | 9 | N/A | N/A | 7 | N/A | N/A | 38 | 0.536 | |
| SSP | |||||||||
| Tactile | 9 | 2.56 | 2 | 7 | 1.57 | 0 | 29 | 0.837 | |
| Taste/smell | 9 | 1.67 | 0 | 7 | 0.71 | 0 | 28.5 | 0.758 | |
| Movement | 9 | − 0.67 | 0 | 7 | 0.29 | 0 | 41.5 | 0.299 | |
| Under-responsive/seeks sensation | 9 | 4.44 | 6 | 7 | 0.71 | 2 | 19 | 0.21 | |
| Auditory filtering | 9 | 4 | 3 | 7 | 0.29 | − 1 | 16 | 0.114 | |
| Low energy/weak | 9 | 1.67 | 2 | 7 | − 0.71 | 0 | 24 | 0.47 | |
| Visual/auditory sensitivity | 9 | 1.89 | 3 | 7 | − 0.86 | 0 | 13 | 0.055 | |
| Total | 9 | 14.33 | 8 | 7 | 1 | − 8 | 14.5 | 0.071 | |
| Vineland-II | |||||||||
| Communication | 7 | 4 | 0 | 6 | 2.83 | 2 | 22 | 1 | |
| Daily living skills | 7 | 3.29 | 1 | 6 | 1.17 | 0.5 | 14.5 | 0.366 | |
| Socialization | 7 | 3 | 1 | 6 | − 0.5 | − 0.5 | 12 | 0.234 | |
| Motor | 6 | 1 | 0 | 6 | 3.17 | 0 | 20.5 | 0.699 | |
| Adaptive behavior composite | 7 | 3.14 | 2 | 6 | 2 | 2 | 21 | 1 | |
| Internalizing | 7 | − 1.14 | − 1 | 6 | − 0.5 | 0 | 29 | 0.295 | |
| Externalizing | 7 | − 1.14 | − 1 | 6 | − 0.17 | 0 | 25.5 | 0.534 | |
| Maladaptive | 6 | − 1.33 | 0 | 6 | − 0.5 | − 0.5 | 18 | 1 | |
| MSEL | |||||||||
| Gross motor | 7 | − 1.57 | 0 | 7 | − 0.86 | 0 | 22 | 0.805 | |
| Visual reception | 7 | 0.29 | 0 | 7 | 2.86 | 4 | 34 | 0.259 | |
| Fine motor | 7 | − 0.29 | 0 | 7 | 0.71 | 0 | 32 | 0.383 | |
| Receptive language | 7 | − 1.86 | − 1 | 7 | 1.71 | 1 | 35.5 | 0.165 | |
| Expressive language | 7 | 0.43 | 0 | 7 | 0.43 | 0 | 22 | 0.805 | |
| MCDI | |||||||||
| Phrases understood | 7 | 0.71 | 0 | 7 | 1.43 | 0 | 29.5 | 0.535 | |
| Words understood | 7 | − 8.14 | 0 | 7 | 7 | 1 | 29 | 0.62 | |
| Words produced | 7 | − 8.43 | 0 | 7 | 2.57 | 0 | 23 | 0.902 | |
| Early gestures | 7 | 1.86 | 1 | 7 | − 0.27 | 0 | 9 | 0.053 | |
| Later gestures | 7 | 2.71 | 1 | 7 | 0.86 | 1 | 26 | 0.902 | |
| Total gestures | 7 | 4.57 | 1 | 7 | 0.57 | 1 | 18 | 0.456 |
*CGI-I scores reflect results at Week 12 only; Vineland-II domain and composite values are standard scores; MSEL values are age equivalents
ABC Aberrant Behavior Checklist; AE age equivalent; CGI Clinical Global Impression-Improvement Scale; MCDI Macarthur-Bates Communicative Development Inventory; MSEL Mullen Scales of Early Learning; RBS Repetitive Behavior Scale-Revised; SSP Short Sensory Profile