| Methods |
Five‐week randomised, double‐blind two‐centre study |
| Participants |
In‐ and outpatients fulfilling DSM‐III‐R criteria for major depression, with a score of at least 16 on the Hamilton Rating Scale for Depression‐17 item (HDRS‐17).
Age: over 60 years
Exclusion criteria: serious suicidal risk, glaucoma, chronic urinary retention, prostatic hypertrophy, significant organic illness, severe organic brain disease, history of seizures, schizophrenia, hypo‐ or hyperthyroidism, history of severe allergy, known allergy to imipramine, history of less than 1 year of alcohol or drug abuse. |
| Interventions |
Fluoxetine: 10 participants
Trimipramine: 9 participants
Fluoxetine dose: 20 mg/day
Trimipramine dose: 150 mg/day |
| Outcomes |
HDRS‐17, Montgomery and Asberg Scale for Depression (MADRS) |
| Notes |
This study focuses on sleep related problems
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 |
Double blind, no further information |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Quote: "since investigators were blind with regard to treatment", no further information |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Number and reasons for dropout reported. Scores reported without denominators |
| Selective reporting (reporting bias) |
Unclear risk |
Side effects not clearly reported. Mean endpoint scores and standard deviation reported |
| Other bias |
High risk |
Quote: "this work was supported by Lilly Deutschland", this company produces fluoxetine |
