| Methods |
Fifty‐two week double‐blind, randomised, multicentre study |
| Participants |
Outpatients fulfilling ICD‐10 criteria for major depression, with a Mini Mental State Examination (MMSE) score of at least 22 and a Hamilton Rating Scale for Depression (HDRS‐21) score of at least 18.
Age: over 65 years
Exclusion criteria: concurrent major medical disorders, dementia, any history of schizophrenia, psychosis; alcohol or drug dependence; major suicide risk; use of long‐acting neuroleptic drugs within 6 months or oral neuroleptics within 2 weeks before the study entry; ECT; daily use of benzodiazepines within 8 weeks or SSRI within 4 weeks, MAOI within 3 weeks, TCA within 1 week before the study entry. |
| Interventions |
Fluoxetine: 119 participants
Paroxetine: 123 participants
Fluoxetine dose range: 20‐60 mg/day
Paroxetine dose range: 20‐40 mg/day |
| Outcomes |
HDRS‐21, Clinical Anxiety Scale, Buschke Selective Reminding Test (BSRT), Blessed Information and Memory Test (BIMT), Clifton Assessment Scale (CLAS), Cancellation Task Test (CTT), Wechsler Paried Word Test (WPW), Mini Mental Sate Evaluation (MMSE) and Clinical Global Impression (CGI) |
| Notes |
Depression response: total score less than 10 on the HDRS‐21
Anxiety response: total score less than 8 on the Covi Anxiety scale (CAS)
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 |
No information provided |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Unclear if raters were independent and unclear if blinding was successful |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
No information provided |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Rating scale scores reported without denominator |
| Selective reporting (reporting bias) |
High risk |
Standard deviations not reported (HDRS). No endpoint scores (CGI, CAS) |
| Other bias |
High risk |
The study was supported by SmithKline. This company produces paroxetine |
