Table 10 Van Heeringen et al., 1996
Domain | Description | Review author’s judgement |
|---|---|---|
Sequence generation | The randomization method is not described | “Unclear” |
Allocation concealment | The exact method is not described. | “Unclear” |
Blinding of participants, personnel, and outcome | The study is defined as double blind. The issue is not addressed by the authors. | “Unclear” |
Incomplete outcome data | The main outcome was the HDRS score. There were 6 drop outs in the mianserin group and 15 dropouts in the placebo group. 2 patients in the mianserin group and 11 in the placebo group withdrew due to lack of efficacy. 2 dropouts in the mianserin group and 4 in the placebo group due to AEs. ITT analysis. Missing data imputation method: LOCF approach. Over one third of the patients withdrew from the study (38%), No study protocol available. All pre-specified outcomes are reported in the pre-specified way. | “No” |
Selective outcome reporting | No study protocol available. All pre-specified outcomes are reported in the pre-specified way. | “Yes” |
Other sources of bias | The study seems to be free of other sources of bias. | “Yes” |