Table 3.
Exploratory Analysis of Efficacy From Week 2 to Week 8.
| Baseline | Change | Endpoint | |||||
|---|---|---|---|---|---|---|---|
| Mean | SD | Mean | SE | Difference | 95% CI | P value | |
| MADRS | – | – | – | – | −7.08 | [–12.50 to –1.69] | 0.0100 |
| Placebo | 21.2 | 3.38 | –6.64 | 1.43 | – | – | – |
| Cannabidiol | 21.5 | 2.95 | –13.72 | 2.38 | – | – | – |
| CGI severity | – | – | – | – | –0.50 | [–1.74 to 0.74] | 0.4303 |
| Placebo | 4.13 | 0.70 | –1.06 | 0.45 | – | – | – |
| Cannabidiol | 4.09 | 0.60 | –1.56 | 0.46 | – | – | – |
| HAMD | – | – | – | – | –6.18 | [–9.58 to –2.77] | 0.0004 |
| Placebo | 13.80 | 2.12 | –2.62 | 1.29; | – | – | – |
| Cannabidiol | 14.30 | 2.22 | –8.80 | 1.16 | – | – | – |
| PHQ-9 | – | – | – | – | –4.09 | [–8.17 to 0.01] | 0.0501 |
| Placebo | 14.02 | 2.39 | –4.33 | 1.28 | – | – | – |
| Cannabidiol | 14.46 | 1.96 | –8.42 | 5.1 | – | – | – |
| HAMA | – | – | – | – | –2.94 | [–7.08 to 1.19] | 0.1625 |
| Placebo | 14.99 | 2.22 | –4.52 | 1.27 | – | – | – |
| Cannabidiol | 15.33 | 2.82 | –7.46 | 1.69; | – | – | – |
| BPRS | – | – | – | – | –4.02 | [–8.07 to 0.03] | 0.0518 |
| Placebo | 31.4 | 3.18 | –2.62 | 1.10 | – | – | – |
| Cannabidiol | 32.1 | 3.48 | –6.64 | 1.77 | – | – | – |
| FAST | – | – | – | – | –2.02 | [–14.0 to 9.97] | 0.7413 |
| Placebo | 38.4 | 3.81 | –8.44 | 4.67 | – | – | – |
| Cannabidiol | 38.5 | 4.21 | –10.46 | 3.76 | – | – | – |
Note. Exploratory analysis of efficacy showing the changes in scale scores from baseline (week 2) to endpoint (week 8) in those patients who were not early responders. Mean and 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.