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 |