Methods |
Ten‐week double‐blind, randomised, multicentre study |
Participants |
In‐ and outpatients fulfilling DSM‐III‐R criteria for major depressive disorder, with a score of at least 16 on the Hamilton Rating Scale for Depression‐17 item (HDRS‐17).
Age: over 60 years
Exclusion criteria: mental organic disorder, Mini Mental State Examination (MMSE) less than 24, high suicide risk, history of alcohol or drug abuse, severe physical illness, epilepsy, schizophrenia. |
Interventions |
Fluoxetine: 32 participants
Amitriptyline: 33 participants
Fluoxetine dose: 20 mg/day
Amitriptyline dose range: 50‐100 mg/day
Patients taking lorazepam 5 mg/day for at least 6 months before enrolment were allowed to continue; triazolam was allowed (0.25 mg/day) during the first 2 weeks for insomnia |
Outcomes |
HDRS‐17, Montgomery and Asberg Scale for Depression (MADRS), Covi Anxiety Scale (CAS), Clinical Global Impression (CGI) Severity and Improvement |
Notes |
Response: decrease of at least 50% in the HDRS‐17 total score or a total score less than 10
Funding: unclear |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Quote: "randomised trial", no further information |
Allocation concealment (selection bias) |
Unclear risk |
No information provided |
Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Insufficient 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: "all ratings were conducted under double blind condition", no further information |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Rating scale scores reported without denominators. Number and reasons for discontinuation not clear |
Selective reporting (reporting bias) |
Unclear risk |
Incidence of adverse effects not clear |
Other bias |
Unclear risk |
Funding: unclear |