Table 2.
Availability of information on efficacy outcomes based on intent-to-treat with last observation carried forward data by trial*
| Author (reference) |
|||||||
|---|---|---|---|---|---|---|---|
| Burke (6) | Lepola (7) | SCT-MD-02 (11) | Lalit (39)† | Colonna (8) | Moore (9) | Yevtushenko (10) | |
| Used data: | |||||||
| published | + | + | – | + | + | + | + |
| unpublished | + | + | + | – | – | – | – |
| Duration (weeks) | 8 | 8 | 8 | 4 | 24 | 8 | 6 |
| MADRS change: | |||||||
| week 1 | + | + | + | – | – | + | + |
| week 4 | + | + | + | – | – | + | + |
| week 6 | + | + | + | – | – | – | + |
| week 8 | + | + | + | – | + | + | – |
| week 24 | – | – | – | – | + | – | – |
| Variability | SD | SD | SD | – | from CI, imput‡ | from P | from SE§ |
| Response rates: | |||||||
| week 2 | – | + | – | + | – | – | – |
| week 4 | – | + | – | + | – | – | – |
| week 6 | – | + | – | – | – | – | + |
| week 8 | + | + | + | – | + | + | – |
| week 24 | – | – | – | – | + | – | – |
| CGI-S change: | |||||||
| week 6 | – | – | – | – | – | – | + |
| week 8 | + | + | + | – | + | + | – |
| week 24 | – | – | – | – | + | – | – |
| Variability | from SE | imput | from SE | – | imput, from P║ | from P | from SE |
*Abbreviations: MADRS – Montgomery-Asberg Depression Rating Scale (33); SD – standard deviation; SE – standard error; CI – confidence interval; CGI-S – Clinical Global Impression-severity (35).
†HAM-D17 – 17-item Hamilton Depression Rating Scale (HAM-D17) (34) was used for quantification of depression but, just as with CGI-S, no post-baseline numerical data and measures of variability were reported. Graphical presentations did not allow for data extraction. Response was defined as ≥50% reduction in HAM-D17.
‡For week 24 SD recovered from CI of difference, for week 8 imputed (37).
§Numerical values reported for week 6, for weeks 1 and 4 mean and SE graph-read.
║For week 8 SD imputed, for week 24 from P.