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. 2019 Jun 3;2019(6):CD001026. doi: 10.1002/14651858.CD001026.pub2

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.