| Methods |
Nine‐week, randomised, double‐blind study. |
| Participants |
Inclusion criteria: patients with Montgomery and Asberg Depression Rating Scale (MADRS) 20+.
Age range: 19‐85 years.
Country: Australia.
Setting: family practice. |
| Interventions |
Paroxetine versus amitriptyline |
| Outcomes |
Montgomery and Asberg Depression Rating Scale (MADRS), Clinical Global Impression (CGI), dropouts. |
| Notes |
None. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "patients were randomly assigned (...) using a computer generated randomization list". |
| Allocation concealment (selection bias) |
Unclear risk |
No information provided. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "double blind (...) medication was blinded by over‐encapsulation of marketed forms of paroxetine and amitriptyline in identical capsules. To maintain the blinding, placebo was given at night to patients receiving paroxetine and in the morning to patients receiving amitriptyline". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Quote: "double blind". No further details. |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Quote: "all patients randomized to active treatment and fro whom one valid post‐randomization evaluation was available within 4 days of intake of medication, were included in the Intention‐to‐treat (ITT) analysis. Three hundred and six patients were eligible for the ITT analysis and all efficacy variables were analysed using this population. All patients (381) were included in the safety analysis; however, six patients were not evaluable by treatment due to inconsistent treatment allocation". |
| Selective reporting (reporting bias) |
Low risk |
Outcomes data were reported. |
| Other bias |
Unclear risk |
Sponsorship bias cannot be ruled out. |
