| Methods |
Twelve‐week randomised, double‐blind study |
| Participants |
Outpatients fulfilling DSM‐III‐R criteria for major depressive episode (single or recurrent), without psychotic features, with a score of at least 18 on the Hamilton Rating Scale for Depression‐ 24 item (HDRS‐24).
Age: over 60 years
Exclusion criteria: DSM‐III‐R criteria for any other psychiatric disorder, significant cognitive impairment (Mini Mental State Examination less than 24), any medical contraindication to any antidepressant therapy, endocrine, cardiovascular, gastrointestinal, renal disease, failure to respond to ECT in a prior depressive episode or to adequate trials (6 weeks) of 2 or more antidepressants. |
| Interventions |
Fluoxetine: 119 participants
Sertraline: 117 participants
Fluoxetine dose range: 20‐40 mg/day
Sertraline dose range: 50‐100 mg/day
Temazepam and chloral hydrate were allowed for sleep |
| Outcomes |
Primary outcome: HDRS‐24 (total and factor scores), Clinical Global Impression (CGI) Severity, Efficacy
Secondary outcomes: Montgomery and Asberg Scale for Depression (MADRS), Hamilton Rating Scale for Anxiety (HAM‐A), Profile Of Mood State (POMS), Beck Depression Inventory (BDI), Quality of Life Enjoyment and Satisfaction Questionnaire (Q‐LES‐Q) |
| 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: "double dummy procedure was used to ensured patients and physician blindness to treatment assignment", 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 |
Scores reported without denominator. Number and reasons for dropout not clearly reported |
| Selective reporting (reporting bias) |
Unclear risk |
Adverse events reported. End point scores reported without standard deviation |
| Other bias |
High risk |
Quote: "supported by a grant from Pfizer", this company produces sertraline |
