Falk 1989.
| Methods | Six‐week randomised, double‐blind study | |
| Participants | Outpatients fulfilling DSM‐III criteria for unipolar major depression (single or recurrent), with the present episode lasting 4 weeks or more and with a score of at least 20 on the Hamilton Rating Scale for Depression‐21 item (HDRS‐21). Age: over 62 years Exclusion criteria: serious medical illness, unstable cardiac arrhythmia, seizure disorders, history of allergy to either drug, severe psychosis, suicidal symptoms or DSM‐II diagnosis of schizophrenia, bipolar disorder, organic mental disorder, substance abuse disorder within the past year or paranoid disorders, use of either drugs within 1 month preceding study entry, MAOI in the prior 14 days or other antidepressants at the time of entry. |
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| Interventions | Fluoxetine: 14 participants Trazodone: 13 participants Fluoxetine dose range: 20‐60 mg/day Trazodone dose range: 50‐400 mg/day Only use of benzodiazepines and chloral hydrate for sleep were allowed | |
| Outcomes | HDRS‐21, Clinical Global Impression (CGI), Treatment Emergent Symptom Scale (TESS) | |
| Notes | Funding: by industry | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomised, no further information |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Double blind, no further information |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "all capsules were identical", no further information |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Scores reported without denominators. Reasons and number of dropouts described |
| Selective reporting (reporting bias) | Unclear risk | Side effects reported. Scores reported for each follow‐up with standard deviations |
| Other bias | High risk | Quote: "this research was supported by a grant from Eli Lilly and Company", and this company produces fluoxetine |