A randomized controlled trial of intranasal oxytocin in Phelan-McDermid syndrome

Fastman, J.; Foss-Feig, J.; Frank, Y.; Halpern, D.; Harony-Nicolas, H.; Layton, C.; Sandin, S.; Siper, P.; Tang, L.; Trelles, P.; Zweifach, J.; Buxbaum, J. D.; Kolevzon, A.

doi:10.1186/s13229-021-00459-1

Molecular Autism

Table 2 Comparison across groups of mean change from baseline to week 12

From: A randomized controlled trial of intranasal oxytocin in Phelan-McDermid syndrome

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

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ISSN: 2040-2392

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