Table 3.
Liebowitz social anxiety total scores, severity categorization and changes in total scorea
Placebo (n = 4) |
MDMA (n = 8)c |
||
---|---|---|---|
Primary efficacy variable LSAS total score, mean (SD) | |||
Baseline | 83.3 (11.9) | 91.8 (15.8) | |
Primary endpoint | 64.0 (13.3) | 46.4 (15.2) | |
Changeb | − 19.3 (18.8) | − 44.1 (14.8) | |
P valueb | 0.037 | ||
Primary endpoint, no. (%) LSAS 20-point reduction | |||
Yes | 2 (50.0) | 6 (85.7) | |
No | 2 (50.0) | 1 (14.3) | |
LSAS severity categoriesd | |||
Baseline | |||
Marked | 2 (50.0) | 2 (25.0) | |
Severe | 2 (50.0) | 3 (37.5) | |
Very severe | 0 | 3 (37.5) | |
Primary endpoint | |||
Normal | 2 (50.0) | 5 (71.4) | |
Moderate | 0 | 1 (12.5) | |
Marked | 2 (50.0) | 1 (12.5) | |
Change baseline to primary endpoint | |||
No change | 1 (25.0) | 0 | |
Reduction of one level | 1 (25.0) | 0 | |
Reduction of two levels | 1 (25.0) | 4 (57.1) | |
Reduction of three levels | 1 (25.0) | 2 (28.6) | |
Reduction of four levels | 0 | 1 (12.5) | |
LSAS total score, mean (SD) | |||
Baseline | 83.3 (11.9) | 91.8 (15.8) | |
6-month follow-up | 60.0 (17.4) | 42.9 (20.4) | |
Changeb | − 23.3 (18.0) | − 47.7 (14.7) | |
P valueb | 0.036 |
Abbreviations: LSAS, Liebowitz Social Anxiety Scale; N, number of participants
aOutcomes are based on intent-to-treat set
bChange from baseline
cN = 7 in MDMA group after baseline
dSeverity categories defined as LSAS total scores ranging from 0 to 54 (normal), 55–65 (moderate), 66–80 (marked), 81–95 (severe), 96–200 (very severe)