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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)