| 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 20 on Hamilton Rating Scale for Depression (HDRS), of 8 on Raskin Depression Scale (RDS).
Age range: 23‐69 years
Exclusion criteria: suicide risk, history of schizophrenia or other psychotic state likely to be aggravated by imipramine, organic brain disease, history of seizures; glaucoma, chronic urinary retention or serious cardiovascular disease; history of multiple adverse reaction to drugs, drug or alcohol abuse, pregnancy. |
| Interventions |
Fluoxetine: 20 participants
Imipramine: 20 participants
Fluoxetine dose range: 60‐80 mg/day
Imipramine dose range: 125‐300 mg/day |
| Outcomes |
HDRS, RDS, Covi Anxiety scale (CAS), Clinical Global Impressions (CGI) |
| Notes |
Patients over 65 years in the imipramine group only
Funding: by academy |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "randomly assigned", 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: "the study drugs and placebo were supplied as identical capsules". No other information |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Unclear if raters were independent and unclear if blinding was successful |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Criteria and number of dropouts reported, but not included in the analysis |
| Selective reporting (reporting bias) |
Unclear risk |
Scores at rating scales were reported without standard deviations |
| Other bias |
Low risk |
Funding: by academy |
