Chouinard 1985.
| Methods | Five‐week double‐blind, randomised study | |
| Participants | Outpatients fulfilling Research Diagnostic Criteria (RDC) criteria for major depressive disorder, with a score of at least 21 on Hamilton Rating Scale for Depression (HDRS‐17) and of at least 8 on the Raskin Depression Scale (RAS). Age range: 21‐70 years Exclusion criteria: physical illness, schizophrenia, schizoaffective illness, chronic or acute organic brain syndrome, mental deficiency, alcoholism, epilepsy, drug addiction. |
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| Interventions | Fluoxetine: 23 participants Amitriptyline: 28 participants Fluoxetine dose range: 40‐80 mg/day Amitriptyline dose range: 100‐300 mg/day Benzodiazepines were allowed for agitation and insomnia | |
| Outcomes | Primary outcome: HDRS‐17, Clinical Global Impression (CGI), Efficacy Index‐Side Effects rating (EISE) Secondary outcomes: Hamilton Rating Scale for Anxiety (HAM‐A) and Zung Depression Scale (SDS) |
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| Notes | One patient attempted suicide in the fluoxetine group Funding: unclear | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "randomly assigned. Assigment was stratified to ensure balanced distribution of male and female patients to each of the two study drug regimen". No other information provided |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Double blind, no other information |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "double blind conditions in identical capsules", no further information |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Double blind, no other information |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Scores reported without standard deviations. Reasons for withdrawal reported, but withdrawals not included in analysis |
| Selective reporting (reporting bias) | Unclear risk | Side effects reported only with an incidence over 10% |
| Other bias | Unclear risk | Funding: unclear |