| Methods |
Six‐week double‐blind, randomised study |
| Participants |
Outpatients fulfilling DSM‐III criteria for major depression (unipolar), with a score of at least 17 on the Hamilton Rating Scale for Depression (HDRS‐17).
Age range: 18‐75 years
Exclusion criteria: significant physical illness, lactation, pregnancy, history of schizophrenia or drug or alcohol abuse, current use of antidepressant. |
| Interventions |
Fluoxetine: 30 participants
Dothiepin: 30 participants
Fluoxetine dose range: 20‐40 mg/day
Dothiepine dose range: 100‐200 mg/day
Benzodiazepines were allowed for sedation at the discretion of the doctor |
| Outcomes |
HDRS, Montgomery and Asberg Scale for Depression (MADRS), Clinical Global Impression (CGI) Severity and Improvement, Patient Global Impression (PGI) |
| 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 |
Quote: "double blind", no further information |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Quote: "all patients took identical capsules", no further information |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
No information provided |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Number and reasons for dropouts were reported. Scores reported without denominators |
| Selective reporting (reporting bias) |
Unclear risk |
Only most common side effects were reported. Mean scores were reported without standard deviations. No endpoint scores (MADRS, CGI) |
| Other bias |
High risk |
In the aknowledgements authors thank Eli Lilly Company. This company produces fluoxetine and probably the study was supported by this industry |
