Yamaoka 1994.
| Methods | Type of trial: parallel Randomised: yes Allocation concealment: unclear Double‐blinding: yes Study quality: low (because of high dropout rates) Duration of treatment: 4 weeks Cointervention: not available |
|
| Participants | Setting: psychiatric OP Diagnosis: major depressive disorder (DSM‐III) Age (mean): 44.4 years Men/women: 8/11 Baseline depressive severity (mean): 26.1 (SD 8.8) on HRSD‐24 Baseline anxiety severity: NS |
|
| Interventions | Mianserin 30–60 mg + mexazolam 3 mg | |
| Outcomes | HRSD‐24 up to 4 weeks | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Participants randomised, but no details on how random sequence generated. |
| Allocation concealment (selection bias) | Unclear risk | Details of allocation concealment not reported. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "double blind", "placebo controlled." Further details not reported. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Details of outcome assessor blinding not reported. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Dropout was a large proportion (4/16 of intervention group and 9/16 of control group) and completer analysis was done. |
| Selective reporting (reporting bias) | Unclear risk | Study protocol not available; thus, unsure if all of prespecified outcomes of interest reported in prespecified way. |
| Other bias | Unclear risk | Insufficient information to assess other bias. |
CGI: Clinical Global Impression; CPRS: Comprehensive Psychopathological Rating Scale; CPRS‐VAS: Comprehensive Psychopathological Rating Scale – Visual Analogue Scale; DSM‐III: Diagnostic and Statistical Manual 3rd Edition; DSM‐III‐R: Diagnostic and Statistical Manual 3rd Revised Edition; DSM‐IV: Diagnostic and Statistical Manual 4th Edition; HRSD: Hamilton Rating Scale for Depression; IP: inpatient; OP: outpatient; SD: standard deviation; VAS: Visual Analogue Scale.