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

Smith 2002.

Methods Type of trial: parallel
Randomised: yes
Allocation concealment: unclear
Double‐blinding: yes
Study quality: intermediate
Duration of treatment: 12 weeks
Cointervention: not available
Participants Setting: psychiatric OP
Diagnosis: non‐psychotic major depressive disorder (DSM‐IV), not precipitated by life stressors
Age (mean): 41.1 years
Men/women: 25/25
Baseline depressive severity (mean): 22.4 on HRSD‐17
Baseline anxiety severity: 58% of participants were described as "aroused."
Interventions Fluoxetine 20–40 mg + clonazepam 0.5–1 mg
Outcomes HRSD‐17, CGI up to 18 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: "using a traditional double‐blind parallel group design." 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 (13/27 of intervention group and 5/25 of control group) and detail of imputing method not reported.
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.