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 |
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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." |
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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. |