Table 3. Primary, Secondary, and Exploratory End Points.
| Primary, secondary and exploratory end points | Mean (SD) | Difference of week 6 and baseline between Placebo and minocycline (95% CI)a | P value | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Pre-treatment | Post-treatment | |||||||||
| Patients, No. | Minocycline, mean (SD) | Patients, No. | Placebo, mean (SD) | Patients, No. | Minocycline, mean (SD) | Patients, No. | Placebo, mean (SD) | |||
| MADRS | 81 | 26.4 (4.8) | 87 | 26.6 (5.1) | 69 | 17.6 (7.8) | 75 | 18.7 (9.0) | 1.46 (−1.04 to 3.96) | .25 |
| BDI II | 78 | 32.3 (9.0) | 87 | 32.9 (10.4) | 66 | 21.6 (12.0) | 72 | 23.6 (13.2) | 1.56 (−2.00to 5.11) | .39 |
| CGI | 81 | 4.8 (0.6) | 87 | 4.9 (0.7) | 69 | 3.9 (1.1) | 75 | 4.0 (1.2) | 0.05 (−0.29 to 0.40) | .77 |
| HAMD-6 | 81 | 11.4 (2.2) | 87 | 11.4 (2.1) | 69 | 7.4 (3.5) | 71 | 7.6 (6.7) | 0.33 (−0.77 to 1.42) | .56 |
| HAMD-17 | 77 | 20.0 (3.5) | 81 | 20.3 (3.5) | 68 | 13.1 (5.9) | 71 | 14.2 (6.7) | 1.16 (−0.62 to 2.93) | .20 |
| SCL-GSI | 81 | 68.7 (6.7) | 87 | 66.9 (7.0) | 66 | 62.3 (10.7) | 72 | 62.0 (10.1) | 1.24 (−1.76 to 4.25) | .42 |
| SCL-PSDI | 81 | 66.3 (4.9) | 87 | 66.1 (6.0) | 65 | 60.2 (8.3) | 72 | 60.2 (8.9) | 0.68 (−1.83 to 3.18) | .59 |
| SCL-PST | 81 | 64.4 (6.6) | 87 | 62.2 (6.0) | 66 | 60.5 (10.1) | 72 | 59.5 (8.9) | 0.85 (−3.53 to 5.24) | .39 |
| TMT-A | 80 | 34.7 (16.6) | 87 | 35.1 (14.3) | 69 | 29.9 (12.2) | 74 | 30.4 (14.1) | 0.56 (−3.81 to 4.93) | .80 |
| TMT-B | 79 | 77.5 (32.7) | 85 | 76.1 (32.3) | 69 | 68.1 (27.6) | 72 | 68.8 (29.1) | 1.67 (−7.73 to 11.11) | .73 |
| Log CRP | 81 | −0.10 (1.6) | 86 | −0.49 (1.4) | 50 | 0.37 (1.2) | 57 | 0.03 (1.3) | 0.24 (−0.04 to 0.53) | .09 |
| Log Leukocytes | 76 | 1.96 (0.31) | 79 | 1.95 (1.85) | 66 | 1.77 (0.29) | 69 | 1.82 (0.28) | 0.06 (0.00 to 0.12) | .05 |
Abbreviations: BDI II, Beck’s depression inventory Version II; CGI, clinical global impression scale; HAMD, Hamilton Depression Rating Scale; MADRS, Montgomery Asberg Depression Rating Scale; SCL-GSI, global severity index; SCL-PSDI, positive symptom distress; SCL-PST, positive symptom total; TMT, trail making test, version A or B.
a
The differences week 6 to baseline between the two treatment groups are based on the difference of least square means of linear mixed effects models for repeated measures.