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 |