Table 2.
Changes in depressive symptoms
| Group | Stage | Treatment | Time | n | Mean (s.d.) | Change from baseline (s.d.) | Within-subject Cohen’s d | Response (%) |
|---|---|---|---|---|---|---|---|---|
|
PA group (ntotal = 17) |
Stage 1 (blinded) | Placebo (ntotal = 17) | Day −1 | 17 | 25.5 (7.25) | – | – | – |
| Day 8 | 16 | 23.6 (8.29) | –1.9 (6.04) | −0.31 | 12.5 | |||
| Day 14 | 17 | 21.9 (10.71) | –3.6 (7.67) | −0.47 | 11.8 | |||
| Stage 2 (open label) | DMT (after placebo; ntotal = 16) | Day 22 | 14 | 14.4 (11.72) | –10.6 (12.03) | −0.88 | 42.9 | |
| Day 29 | 16 | 14.4 (10.93) | –10.8 (12.77) | −0.85 | 43.8 | |||
| Day 45 | 16 | 11.9 (9.94) | –13.3 (12.93) | −1.02 | 50.0 | |||
| Day 105 | 14 | 9.6 (8.05) | –15.4 (12.21) | −1.26 | 50.0 | |||
| Day 224 | 12 | 14.4 (9.82) | –8.4 (12.45) | −0.67 | 50.0 | |||
| AA group (ntotal = 17) | Stage 1 (blinded) | DMT (ntotal = 17) | Day −1 | 17 | 26.3 (6.14) | – | – | – |
| Day 8 | 16 | 13.3 (10.36) | –12.7 (10.38) | −1.22 | 43.8 | |||
| Day 14 | 17 | 15.3 (10.20) | –11.0 (10.11) | −1.35 | 35.3 | |||
| Stage 2 (open label) | DMT (after active; ntotal = 13a) | Day 22 | 12 | 11.1 (8.53) | –13.4 (9.89) | −1.15 | 58.3 | |
| Day 29 | 12 | 11.2 (9.49) | –13.3 (11.57) | −0.94 | 58.3 | |||
| Day 45 | 12 | 12.1 (10.29) | –12.4 (13.13) | −0.94 | 50.0 | |||
| Day 105 | 12 | 16.7 (12.26) | –7.8 (13.63) | −0.59 | 41.7 | |||
| Day 224 | 9 | 16.0 (7.79) | –7.8 (12.02) | −0.64 | 33.3 | |||
| All participants (ntotal = 34) | Stage 2 (open label) | DMT (one or two doses (ntotal = 33) | Day 105 | 30 | 13.7 (11.15) | −11.8 (13.16) | – | 46.7 |
| Day 224 | 25 | 15.2 (9.28) | −9.2 (12.0) | – | 44.0 |
MADRS outcome data at all time points and in both stages, including within-subject Cohen’s d (relative to day −1) and response rates (response defined as ≥50% change from baseline). ntotal, total number of participants; n, number of participants with data. aAA data are without the 4 individuals (A−) who did not receive their second DMT dose.