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Table 2 Participant characteristics

From: Cannabinoid treatment for autism: a proof-of-concept randomized trial

  All Placebo in 1st period; whole- plant in the 2nd Pure cannabinoids in 1st period; placebo in the 2nd Whole-plant in 1st period; pure cannabinoids in 2nd P-valuea
Age: mean ± SD
[median, range]
11.8 ± 4.1
[11.3, 5.1–20.8]
11.7 ± 3.8
[10.7, 5.8–20]
11.6 ± 4.3
[10.3, 5.1–20.4]
12.1 ± 4.3
[12.6, 5.1–20.8]
0.79
Sex (% girls) 20% 16% 16% 28% 0.22
ADOS-2 Total Score
mean ± SD [median, range]
21.8 ± 6.0
[23, 7–32]
22.1 ± 6.5
[23.5, 7–32]
22.5 ± 5.8
[24, 11–32]
20.9 ± 5.8
[21, 9–30]
0.41
VABS Standard Score
mean ± SD [median, range]
52.3 ± 14.5
[51, 20–102]
52.0 ± 15.0
[49, 26–102]
52.4 ± 15.2
[54, 25–89]
52.3 ± 13.6
[52, 20–78]
0.27
CARS Total Score
mean ± SD [median, range]
45.4 ± 8.4
[47.5, 29.5–59]
46.0 ± 8.5
[47.5, 30.5–59]
45.5 ± 8.9
[48.5, 29.5–57.5]
44.6 ± 7.8
[46.5, 31–56.5]
0.55
CGI-S maladaptive behavior
mean ± SD [median, range]
5.6 ± 0.7
[6, 4–7]
5.5 ± 0.7
[6, 4–7]
5.6 ± 0.7
[6, 4–7]
5.6 ± 0.7
[6, 4–7]
0.78
HSQ Total Score (baseline)
mean ± SD [median, range]
3.5 ± 1.7
[3.3, 0.3–8.5]
3.7 ± 1.5
[3.7, 0.7–6.0]
3.2 ± 1.5
[3.1, 0.7–6.6]
3.7 ± 2.1
[3.6, 0.3–8.5]
0.33
SRS-2 Total Score (baseline)
mean ± SD [median, range]
119 ± 27
[121, 53–180]
122 ± 23
[124, 53–159]
118 ± 31
[118, 64–178]
117 ± 27
[117, 66–180]
0.37
APSI Total Score (baseline)
mean ± SD [median, range]
27.1 ± 10.4
[26, 7–54]
28.3 ± 10.3
[27, 11–50]
25.8 ± 10.4
[25, 8–54]
27.4 ± 10.7
[25, 7–48]
0.67
BMI (baseline)
mean ± SD [median, range]
20.8 ± 5.7
[19.0, 12.3–39.6]
20.5 ± 5.2
[19.1, 12.8–34]
20.5 ± 6.0
[19.1, 12.3–39.6]
21.3 ± 6.1
[19.0, 13.9–39.6]
0.67
Epilepsy 9% 8% 8% 10% 0.92
Concomitant medications
Any medication 72% 72% 68% 76% 0.67
Antipsychotics 54% 58% 44% 60% 0.22
SSRIs 15% 12% 16% 16% 0.80
Antiepileptics (also given as mood stabilizers) 12% 12% 12% 12% 1.0
Stimulants 12% 8% 22% 6% 0.033
Benzodiazepines 7% 2% 8% 10% 0.19
Alpha-2 agonists 4% 4% 2% 6% 0.58
  1. ADOS-2 Autism Diagnostic Observation Schedule-2nd edition, (Modules 1, 2 and 3 were used for 55%, 17%, and 28% of the participants, respectively, without significant differences among the 3 study arms); VABS Vineland Adaptive Behavior Scales; CARS Childhood Autism Rating Scale; CGI-S Clinical Global Impression–Severity [5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients; all referencing disruptive behaviors]; HSQ Home Situations Questionnaire; SRS-2 Social Responsiveness Scale-2nd edition; APSI Autism Parenting Stress Index; SSRIs Selective serotonin reuptake inhibitors
  2. aCategorical parameters (sex, epilepsy and medications) were compared using likelihood ratio chi-square tests. Continuous parameters were compared using the Kruskal–Wallis test if data distribution was non-normal but similar across groups (BMI) and using median tests if data distribution was non-normal and different across groups (age, assessment scores)