Table 3.
References | Study Design | Number of Patients | Age | Diagnosis | Melatonin Dosage | Time of Melatonin Supplementation (before Bedtime) | Duration of Melatonin Supplementation |
---|---|---|---|---|---|---|---|
Gupta R, et al. 2005 [92] | Retrospective study | 9 | 2–11 years | ASD | 2.5–5 mg | 45 min | |
Giannotti F, et al. 2006 [93] | Open label | 20 | 2.6–9.1 | ASD | 3 mg (1 mg FR and 2 mg CR)–6mg |
30–40 min | 2 years |
Garstrang J, et al. 2006 [94] | DB-RCT | 7 | 4–16 | ASD ADHD |
5 mg | 4 weeks | |
Andersen IM, et al. 2008 [95] | Retrospective study | 107 | 2−18 | ASD | 0.75–6 mg | 30–60 min | 1.8 ± 1.4 years |
Wasdell MB, et al. 2008 [96] | DB-RCT | 50 | 2.05−17.81 | Severe intellectual loss Cerebral palsy Epilepsy Visual impairment Lack of mobility ASD |
5 mg CR | 20–30 min | 10 days |
Wirojanan J, et al. 2009 [97] | DB-RCT | 12 | 2–15.25 | ASD Fragile X syndrome |
3 mg | 30 min | 2 weeks |
Wright B, et al. 2011 [98] | DB-RCT | 16 | 4–16 | ASD | 2–10 mg | 30–40 min | 3 months |
Cortesi F, et al. 2012 [90] | DB-RCT | 74 | 4–10 | ASD | 3 mg CR | 21:00 | 12 weeks |
Gringras P, et al. 2012 [99] | DB-RCT | 51 | 3.7–15 | DD alone DD and epilepsy DD and ASD DD, ASD, epilepsy DD and “other” |
0.5–12 mg | 45 min | 12 weeks |
Malow B, et al.2012 [59] | Open label | 24 | 3−10 | ASD | 1–6 mg | 30 min | 14 weeks |
Goldman S, et al. 2014 [48] | Open label | 9 | 3−8 | ASD | 1–3 mg | 30 min | 3–6 weeks |
Gringras P, et al. 2017 [100] | DB-RCT | 58 | 2−17 | ASD SMS |
2–5 mg of PedPRM | 13 weeks | |
Maras A, et al. 2018 [101] | DB-RCT | 51 | 2−17.5 | ASD Neurogenetic disorders |
2–10 mg of PedPRM | 30−60 min | 52 weeks |
Schroder CM, et al. 2019 [102] | DB-RCT | 58 | 2−17.5 | ASD SMS |
2–5 mg of PedPRM | 30−60 min | 13 weeks |
Malow BA, et al. 2020 [103] | DB-RCT | 74 | 2−17.5 | ASD SMS |
2–10 mg of PedPRM | 30−60 min | 104 weeks |
DB-RCT—double blind, randomized control trial, CR—controlled-release, FR—fast release, DD—developmental delay, PedPRM—pediatric-appropriate 3 mm diameter prolonged release melatonin minitablet, SMS—Smith–Magenis syndrome.