| Methods |
Six‐week double‐blind, randomised study |
| Participants |
Outpatients fulfilling DSM‐III‐R criteria for major depression, with a score of at least 17 on the Hamilton Rating Scale for Depression‐17 item (HDRS‐17).
Age range: 18‐70 years
Exclusion criteria: acute suicidal ideation, dementia, history of epilepsy, alcoholism in the previous 6 months, other psychoactive substance, pregnancy, lactation, absence of contraception, hepatic, renal, pulmonary, endocrine, cardiac disease, previous failure with SSRI therapy, concomitant use of lithium, warfarin, carbamazepine, theophyline, insulin, hypoglycaemic agents, MAOI or ECT in the previous 2 weeks. |
| Interventions |
Fluoxetine: 94 participants
Fluvoxamine: 90 participants
Fluoxetine dose: 20 mg/day
Fluvoxamine dose: 100 mg/day |
| Outcomes |
Primary outcome: area under the curve of the change in HDRS‐17 total score from baseline
Secondary outcomes: numbers of HDRS‐17 responders, Clinical Global Impression (CGI) Severity and Improvement, Clinical Anxiety Scale (CAS), Irritability Depression and Anxiety Scale (IDAS) total score and sub‐scores, Beck Scale for Suicide Ideation (SSI), Sleep Evaluation and the HDRS‐17 total and subtotal scores |
| 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 |
Double blind, no further information |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Double blind, no further information |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Reasons and number of dropouts were not clear. Rating scale scores reported without denominators |
| Selective reporting (reporting bias) |
Unclear risk |
Scores reported without standard deviations |
| Other bias |
High risk |
Quote: "the study was supported by a grant from Solvay Pharmaceuticals". This company produces maprotiline |
