Methods |
Six‐week randomised, double‐blind study |
Participants |
Outpatients fulfilling DSM‐III‐R or DIS criteria for unipolar major depression, with a score of at least 20 on the Hamilton Rating Scale for Depression‐21 item (HDRS‐21).
Age range: 18‐70 years
Exclusion criteria: any serious psychiatric disorder other than depression, such as schizophrenia, bipolar disorder, panic or obsessive disorder, alcohol or drug abuse within the past six months, serious medical disorders, use of psychoactive drugs that could affect mood. |
Interventions |
Fluoxetine: 20 participants
Amitriptyline : 22 participants
Fluoxetine dose range: 20‐80 mg/day
Amitriptyline dose range: 100‐250 mg/day
Only small amounts of benzodiazepines or chloral hydrate for sleep and anxiety were allowed |
Outcomes |
Diagnostic Interview Schedule, HDRS‐21, Beck Depression Inventory (BDI), Raskin Depression Scale (RDS), Covi Anxiety Scale (CAS) |
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: "study drugs were packaged as identical capsules" |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Double blind, no further information |
Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Rating scale scores reported without denominators. Number and reasons for discontinuation reported |
Selective reporting (reporting bias) |
Unclear risk |
Endpoint scores reported with standard deviations. Only 12 most common side effects reported |
Other bias |
High risk |
Quote: "the study was supported by Eli Lilly, Canada Inc.". Eli Lilly Company produces fluoxetine |