Table 1.
HAMD‐17 Improvement, Response and Remission Rates, and Changes in Weight in Study Completers
| Study 1 | Study 2 | ||||
|---|---|---|---|---|---|
| CHO‐1/PRO‐2 (n = 10) | PRO‐1/CHO‐2 (n = 8) | CHO (n = 14) | PRO (n = 17) | ||
| HAMD17 (Screen) | 17.0 ± 4.2 | 17.4 ± 4.3 | HAMD‐17 (Screen) | 17.7 ± 2.9 | 17.4 ± 2.9 |
| HAMD‐17 (End Phase 1) | 6.5 ± 3.8a | 9.3 ± 4.4a | HAMD‐17 (End week 1) | 12.3 ± 4.1g | 11.1 ± 3.0g |
| HAMD‐17 (End Phase 2) | 4.6 ± 3.9a | 7.9 ± 5.3a | HAMD‐17 (End week 2) | 9.0 ± 5.1g | 7.8 ± 3.4g |
| HAMD‐17 (End week 3) | 6.4 ± 5.8g | 6.1 ± 4.4g | |||
| Response Rate (End Phase 1) | 50% (n = 5/10)b | 50% (n = 4/8)b | Response Rate | 71% (n = 10)h | 76% (n = 13)h |
| Remission Rate (End Phase 1) | 50% (n = 5/10)c | 38% (n = 3/8)c | Remission Rate | 71% (n = 10)i | 71% (n = 12)i |
| Response Rate (End Phase 2) | 88% (n = 7/8)d | 63% (n = 5/8)d | |||
| Remission Rate (End Phase 2) | 88% (n = 7/8)e | 50% (n = 4/8)e | |||
| Weight (Screen) (kg) | 75.4 ± 20.0 | 72.8 ± 11.3 | Weight (Screen)(kg) | 67.2 ± 7.6 | 73.1 ± 14.6 |
| Weight (End Phase 1) (kg) | 76.2 ± 20.3f | 73.2 ± 10.7f | Weight (End week 1) (kg) | 67.8 ± 7.8j | 73.0 ± 14.5j |
| Weight (End Phase 2) (kg) | 73.4 ± 21.4f | 73.2 ± 9.7f | Weight (End week 2) (kg) | 67.9 ± 7.6j | 74.3 ± 14.9j |
| Weight (End week 3) (kg) | 68.2 ± 7.4j | 73.4 ± 14.4j | |||
| Notes | |
| Study 1 | Study 2 |
| CHO‐1/PRO‐2 = CHO in Phase 1, followed by PRO in Phase 2. | CHO = CHO drink |
| PRO‐1/CHO‐2 = PRO in Phase 1, followed by CHO in Phase 2. | PRO = PRO drink |
| a Repeated measures ANOVA: | g Repeated measures ANOVA: |
| Time effect: F = 76.99, df(2,28), P<0.001, η2 p= 0.85 | Time effect: F = 91.48, df(3,87), P<0.001, η2 p= 0.76 |
| Time X Treatment effect: F = 2.67, df(2,28), P = 0.09, η2 p= 0.16 | Time X Treatment effect: F = 0.22, df(3,87), P = 0.88, η2 p= 0.01 |
| b P = 1.00, OR = 1.00, 95% CI(0.16–6.42) | h P = 1.00, OR = 0.77, 95% CI(0.15–3.86) |
| c P = 0.66, OR = 1.67, 95% CI(0.25–11.11) | i P = 1.00, OR = 1.04, 95% CI(0.22–4.96) |
| d P = 0.57, OR = 4.17, 95% CI(0.33–50.0) | j Repeated measures ANOVA: |
| e P = 0.28, OR = 7.14, 95% CI(0.57–100.00) | Time effect: F = 2.36, df(3,84), P = 0.08, η2 p= 0.08 |
| f Repeated measures ANOVA: | Time X Treatment effect: F = 0.73, df(3,84), P = 0.54, η2 p= 0.03 |
| Time effect: F = 1.01, df(2,28), P = 0.38, η2 p= 0.07 | η2 p= Partial eta squared |
| Time X Treatment effect: F = 0.08, df(2,28), P = 0.93, η2 p= 0.01 | |
| η2 p= Partial eta squared | |