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

Feighner 1979.

Methods Type of trial: parallel
Randomised: yes
Allocation concealment: yes
Double‐blinding: yes
Study quality: high
Duration of treatment: 4 weeks
Cointervention: not available
Participants Setting: psychiatric OP
Diagnosis: definite primary depression (Feighner), with moderate‐to‐severe anxiety
Age (mean): 40.6 years
Men/women: 66/124
Baseline depressive severity (mean): 35.2 (SD 8.8) on HRSD‐24
Baseline anxiety severity: moderate/severe
Interventions Amitriptyline 75–150 mg + chlordiazepoxide 30–60 mg
Outcomes HRSD‐24, CGI 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 provided 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: "this multicenter, double‐blind, placebo‐controlled study". 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 Large proportion of participants (18/97 of intervention group and 23/93 of control group) excluded from the analysis.
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.