Table 2.
Main Analysis of Efficacy From Baseline to Week 8.
| Baseline | Change | Endpoint | |||||
|---|---|---|---|---|---|---|---|
| Mean | SD | Mean | SE | Difference | 95% CI | P value | |
| MADRS | – | – | – | – | −0.82 | [–7.81 to 6.17] | 0.8176 |
| Placebo | 26.4 | 6.85 | –14.56 | 2.21 | – | – | –- |
| Cannabidiol | 26.2 | 5.49 | –15.38 | 2.82 | – | – | – |
| CGI severity | – | – | – | – | 0.52 | [–0.59 to 1.63] | 0.3573 |
| Placebo | 4.69 | 0.95 | -2.12 | 0.43 | – | – | – |
| Cannabidiol | 4.50 | 0.92 | -1.60 | 0.37 | – | – | – |
| HAMD | – | – | – | – | –2.47 | [–7.24 to 2.30] | 0.3106 |
| Placebo | 16.7 | 6.25 | –7.82 | 1.58 | – | – | – |
| Cannabidiol | 18.4 | 4.88 | –10.29 | 1.85 | – | – | – |
| PHQ-9 | – | – | – | – | -0.67 | [–5.49 to 4.16] | 0.7860 |
| Placebo | 17.2 | 4.01 | –8.65 | 1.51 | – | – | – |
| Cannabidiol | 17.2 | 4.01 | –9.32 | 1.94 | – | – | – |
| HAMA | – | – | – | – | –0.51 | [–5.55 to 4.54] | 0.8435 |
| Placebo | 16.3 | 7.20 | -8.03 | 1.51 | – | – | – |
| Cannabidiol | 19.1 | 10.5 | -8.54 | 2.08 | – | – | – |
| BPRS | – | – | – | – | –3.24 | [–7.45 to 0.97] | 0.1314 |
| Placebo | 33.7 | 5.16 | –7.16 | 1.68 | – | – | – |
| Cannabidiol | 36.8 | 6.25 | –10.40 | 1.40 | – | – | – |
| FAST | – | – | – | – | 0.52 | [–10.1 to 11.2] | 0.9246 |
| Placebo | 38.1 | 13.9 | –12.05 | 4.57 | – | – | – |
| Cannabidiol | 35.8 | 14.7 | –11.53 | 2.86 | – | – | – |
Note. The main analysis of efficacy shows the changes in scale scores from baseline (week 0) to endpoint (week 8). Mean changes are represented by the estimated mean changes. BPRS = Brief Psychiatric Rating Scale; CGI-S = Clinical Global Impression-Severity scale for depression; FAST = Functioning Assessment Short Test; HAMA = Hamilton Anxiety Rating Scale; HAMD = Hamilton Depression Rating Scale 17 items; MADRS = Montgomery-Åsberg Depression Rating Scale; PHQ-9 = Patient Health Questionnaire-9.