Table 1.
Baseline demographics and outcomes for efficacy samplea.
| POMA | TS-134 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Overall (n = 76) | Placebo (n = 28) | Low dose (n = 21) | High dose (n = 27) | P-values | Overall (n = 60) | Placebo (n = 10) | Low dose (n = 25) | High dose (n = 25) | P-values | |
| Age | 34.43 (9.78) | 32.18 (8.91) | 35 (10.64) | 36.33 (9.85) | 0.28 | 38.25 (9.36) | 38.20 (7.48) | 38.28 (10.01) | 38.32 (9.52) | 1.00 |
| Male (%) | 49% | 57% | 38% | 48% | 0.42 | 68% | 50% | 76% | 68% | 0.36 |
| dACC peak amplitudeb | 1.90 (0.94) | 2.08 (1.29) | 1.75 (0.65) | 1.82 (0.66) | 0.41 | 2.28 (0.94) | 2.39 (1.02) | 2.34 (0.92) | 2.17 (0.96) | 0.77 |
| BPRS totalb | 3.76 (4.68) | 3.75 (4.57) | 3.71 (5.76) | 3.81 (4.00) | 1.00 | 2.32 (4.04) | 1.30 (1.95) | 2.44 (4.50) | 2.52 (4.17) | 0.70 |
| BPRS positiveb | 1.62 (2.05) | 1.54 (1.71) | 1.86 (2.63) | 1.52 (1.91) | 0.82 | 1.02 (1.62) | 1.00 (1.33) | 1.00 (1.55) | 1.00 (1.83) | 1.00 |
| CADSS totalb | 16.12 (14.13) | 18.86 (15.89) | 17.19 (13.14) | 12.44 (12.55) | 0.23 | 11.24 (9.61) | 9.60 (7.43) | 10.28 (7.64) | 12.48 (12.00) | 0.63 |
All values mean (SD), except percentage. dACC amplitude represents peak change from prefusion baseline, calculated as a percentage.
dACC anterior cingulate cortex, BPRS Brief Psychiatric Rating Scale, CADSS Clinician Administered Dissociative States Scale.
aP-values are shown within study. There were also no significant differences for the TS-134 study when the combined placebo group was used.
bDifference on screening day (preinfusion vs postinfusion).