| Methods |
Twelve‐week randomised, double‐blind, multicentre study |
| Participants |
Outpatients fulfilling DSM‐III‐R criteria for major depressive disorder, with a score of at least 18 on the Hamilton Rating Scale for Depression (HDRS‐24) .
Age: over 70 years
Exclusion criteria: any significant medical problem, criteria for any other Axis I psychiatric or neurological disorder, any cognitive impairment, suicidal risk, drug abuse or dependence, any medical contraindication to study medications, history of failure to respond to either ECT or adequate trials with two or more antidepressants. |
| Interventions |
Fluoxetine: 33 participants
Sertraline: 42 participants
Fluoxetine dose range: 20‐40 mg/day
Sertraline dose range: 50‐100 mg/day |
| Outcomes |
HDRS‐24, Hamilton Rating Scale for Anxiety (HAM‐A), Clinical Global Impression (CGI) Severity and Improvement, Profile Of Mood States (POMS), Quality of Life Enjoyment and satisfaction Questionnaire (Q‐LES‐Q). |
| Notes |
Response: decrease of at least 50% in the HDRS‐24 total
Remission: total score of maximum 7 on the HDRS‐24 at the week 10 and 12
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 |
Unclear risk |
Responders at endpoint reported without denominators. Number and reasons for withdrawal were reported |
| Selective reporting (reporting bias) |
Unclear risk |
Only most common side effects reported. Primary endpoint scores reported in figures and without standard deviations |
| Other bias |
Unclear risk |
Funding: unclear |
