Table 2.
Changes in Main Outcome Instruments, Response and Remission Rates for Intent-to-Treat (ITT) Sample
| INTENT-TO-TREAT (n = 189) | ||||||
|---|---|---|---|---|---|---|
| Instrument | SAMe (n = 64) | Escitalopram (n = 65) | Placebo (n = 60) | |||
| Mean | SD | Mean | SD | Mean | SD | |
| HAM-D-17 BSL | 18.98 | 5.09 | 19.25 | 4.88 | 19.43 | 4.07 |
| HAM-D-17 END | 12.79* | 7.38 | 12.94* | 6.98 | 14.32* | 6.92 |
| IDS-SR BSL | 34.87 | 9.74 | 37.54 | 12.35 | 37.44 | 11.56 |
| IDS-SR END | 23.29* | 12.53 | 26.84* | 15.28 | 28.57* | 14.21 |
| CGI-S BSL | 4.38 | 0.76 | 4.44 | 0.69 | 4.29 | 0.65 |
| CGI-S END | 3.08* | 1.46 | 3.14* | 1.44 | 3.28* | 1.37 |
| CGI-I END | 2.73 | 1.24 | 2.76 | 1.24 | 2.90 | 1.24 |
| n | % | n | % | n | % | |
| Responsea | 23 | 35.9 | 22 | 33.8 | 18 | 30.0 |
| Remissiona | 18 | 28.1 | 18 | 27.7 | 10 | 16.7 |
Abbreviations:
HAM-D-17: Hamilton Depression Rating Scale – 17 item
IDS-SR: Inventory of Depressive Symptomatology – Self-Rated
CGI-S: Clinical Global Improvement Scale – Severity
CGI-I: Clinical Global Improvement Scale – Improvement
BSL: Baseline visit
END: End visit
*
P < 0.001 for change from baseline to endpoint
a
There were no significant differences between the 3 treatment groups for response and remission rates based on ≥ 50% improvement in HAM-D-17 score from baseline to end (P > 0.05 for all 2-way and 3-way comparisons) for the ITT sample.