Table 2. Changes in PANSS and BPRS, descriptive statistics and MMRM results adjusted for baseline, full analysis set (modified intention-to-treat).
|
Cannabidiol |
Amisulpride |
Cannabidiol vs Amisulpride |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline to (day) | Mean (s.d., n) | EMM (s.e., df) | P-value | Mean (s.d., n) | EMM (s.e., df) | P-value | Difference (95% CI, df) | P-value | |
| PANSS | |||||||||
| Total | 14 | 18.8 (10.7, 20) | 19.4 (3.4, 36.1) | <0.001 | 18.8 (19.9, 19) | 17.9 (3.5, 36.1) | <0.001 | 1.5 (−8.5 to 11.5, 36.1) | 0.763 |
| 28 | 30.5 (16.4, 17) | 29.5 (4.7, 34.3) | <0.001 | 30.1 (24.7, 18) | 28.5 (4.7, 32.6) | <0.001 | 1.0 (−12.6 to 14.6, 33.7) | 0.884 | |
| Positive | 14 | 6.3 (4.7, 20) | 5.8 (1.0, 36.0) | <0.001 | 5.1 (5.0, 19) | 5.5 (1.0, 36.0) | <0.001 | 0.2 (−2.6 to 3.0, 36.1) | 0.878 |
| 28 | 9.0 (6.1, 17) | 8.2 (1.4, 34.3) | <0.001 | 8.4 (7.5, 18) | 8.7 (1.4, 33.2) | <0.001 | −0.5 (−4.5 to 3.5, 33.8) | 0.800 | |
| Negative | 14 | 4.5 (4.6, 20) | 4.7 (1.1, 36.4) | <0.001 | 3.3 (5.9, 19) | 3.0 (1.1, 36.4) | 0.012 | 1.7 (−1.6 to 5.0, 36.5) | 0.300 |
| 28 | 9.1 (4.9, 17) | 8.7 (1.3, 32.5) | <0.001 | 6.4 (6.0, 18) | 5.8 (1.3, 30.9) | <0.001 | 2.9 (−0.8 to 6.6, 31.9) | 0.116 | |
| General | 14 | 8.0 (5.4, 20) | 9.0 (1.8, 35.9) | <0.001 | 10.4 (11.4, 19) | 9.1 (1.9, 35.9) | <0.001 | −0.1 (−5.4 to 5.2, 36.0) | 0.975 |
| 28 | 12.5 (10.4, 17) | 12.9 (2.5, 33.1) | <0.001 | 15.3 (14.3, 18) | 13.9 (2.5, 31.1) | <0.001 | −0.9 (−8.2 to 6.4, 32.5) | 0.799 | |
| Factor 1 | 14 | 3.0 (4.7, 20) | 2.8 (0.8, 36.0) | <0.001 | 3.3 (5.3, 19) | 3.3 (0.8, 36.0) | <0.001 | −0.5 (−2.7 to 1.7, 36.0) | 0.658 |
| 28 | 4.8 (5.0, 17) | 4.1 (1.2, 30.1) | 0.002 | 4.6 (7.7, 18) | 4.5 (1.2, 28.5) | <0.001 | −0.4 (−3.9 to 3.1, 29.3) | 0.812 | |
| Factor 2 | 14 | 3.1 (4.1, 20) | 3.4 (1.0, 35.9) | 0.002 | 3.2 (5.2, 19) | 2.9 (1.0, 35.9) | 0.008 | 0.4 (−2.5 to 3.4, 36.0) | 0.776 |
| 28 | 8.0 (4.5, 17) | 7.6 (1.2, 30.9) | <0.001 | 6.0 (6.1, 18) | 5.5 (1.2, 29.5) | <0.001 | 2.2 (−1.2 to 5.6, 30.4) | 0.203 | |
| Factor 3 | 14 | 2.5 (2.0, 20) | 2.7 (0.5, 36.1) | <0.001 | 1.7 (3.1, 19) | 1.4 (0.5, 36.2) | 0.011 | 1.2 (−0.3 to 2.8, 36.2) | 0.107 |
| 28 | 3.2 (2.5, 17) | 3.3 (0.7, 35.5) | <0.001 | 3.4 (3.4, 18) | 3.2 (0.7, 33.5) | <0.001 | 0.1 (−1.8 to 2.0, 35.0) | 0.922 | |
| Factor 4 | 14 | 3.2 (2.4, 20) | 3.1 (0.6, 36.0) | <0.001 | 3.2 (2.9, 19) | 3.3 (0.6, 36.0) | <0.001 | −0.2 (−1.9 to 1.4, 36.0) | 0.778 |
| 28 | 5.2 (2.5, 17) | 4.7 (0.8, 35.5) | <0.001 | 5.1 (4.2, 18) | 5.2 (0.8, 33.8) | <0.001 | −0.5 (−2.7 to 1.7, 34.7) | 0.647 | |
| Factor 5 | 14 | 2.0 (2.7, 20) | 2.1 (0.5, 35.6) | <0.001 | 2.9 (3.0, 19) | 2.7 (0.6, 35.6) | <0.001 | −0.5 (−2.1 to 1.1, 35.6) | 0.511 |
| 28 | 3.0 (4.4, 17) | 3.3 (0.7, 29.1) | <0.001 | 4.1 (3.5, 18) | 3.8 (0.7, 27.3) | <0.001 | −0.5 (−2.6 to 1.7, 28.2) | 0.659 | |
| BPRS | |||||||||
| 7 | 6.4 (6.1, 20) | 6.4 (1.8, 35.8) | <0.001 | 7.9 (9.5, 19) | 8.0 (1.8, 35.8) | <0.001 | −1.6 (−6.7 to 3.5, 35.8) | 0.530 | |
| 14 | 14.5 (7.9, 20) | 14.5 (2.2, 35.5) | <0.001 | 12.7 (12.0, 19) | 12.8 (2.2, 35.5) | <0.001 | 1.7 (−4.6 to 8.1, 35.5) | 0.589 | |
| 21 | 18.4 (10.6, 16) | 16.9 (2.8, 35.4) | <0.001 | 14.2 (14.4, 18) | 14.0 (2.8, 33.0) | <0.001 | 2.9 (−5.1 to 10.9, 34.2) | 0.468 | |
| 28 | 20.5 (12.3, 17) | 18.9 (3.2, 33.7) | <0.001 | 19.4 (15.6, 18) | 19.1 (3.1, 32.0) | <0.001 | −0.1 (−9.2 to 8.9, 32.8) | 0.977 | |
Abbreviations: BPRS, Brief Psychiatric Rating Scale; CI, confidence interval; df, degrees of freedom; EMM, estimated marginal mean; MMRM, mixed effects repeated measures model; PANSS, Positive and Negative Syndrome Scale.
Bold indicates statistical significance between groups (P⩽0.05).