. Author manuscript; available in PMC: 2021 Apr 29.

Published in final edited form as: J Am Acad Child Adolesc Psychiatry. 2020 Jan 23;60(2):252–261.e3. doi: 10.1016/j.jaac.2019.12.007

TABLE 2.

Pubertal Development and Change From Baseline in Mean Standard Deviation Scores at Week 106 in Children ≥8 Years of Age Treated With Pediatric Prolonged-Release Melatonin (PedPRM)

SDS	PedPRM group				Placebo group
SDS	Mean (SD)		Range		Mean (SD)		Range
Pubic hair growth	0.881 (1.11), n = 19		−0.43 to 3.04		1.323 (0.998), n = 12		−0.43 to 2.63
Breast development	0.709 (1.16), n = 7		−0.12 to 3.14		NA		NA
Genitalia development	0.692 (0.96), n = 12		−0.55 to 2.12		1.205 (0.8), n = 12		−0.55 to 2.11
Change from baseline	Mean (SD)	Range	(95%CI)	P	Mean (SD)	Range	(95%CI)	P
Pubic hair growth	1.09 (1.24), n = 16	0.0 to 3.40	(0.49, 1.69)	< .0001	1.55(1.11), n = 11	0.0 to 2.85	(0.85, 2.35)	< .001
Breast development	1.78 (1.70), n = 5	0.0 to 3.54	(0.21,3.36)	< .001	NA	NA	NA	NA
Genitalia development	0.74 (1.09), n = 11	0.0 to 2.99	(0.05, 1.43)	< .001	11.30 (1.00), n = 11	0.0 to 2.48	(0.67, 1.94)	< .001

Note: NA = not applicable; SDS = standard deviation score.