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 |
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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 |
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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. |