Methods | Fifty-two-week double-blind, randomised, multicentre study. | |
Participants | Outpatients fulfilling ICD-10 criteria for major depression, with a Mini Mental State Examination score of at least 22, HDRS score of at least 18. Age range: over 65 years old. 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 |
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Interventions | Fluoxetine: 119 participants. Paroxetine: 123 participants. Fluoxetine dose range: 20-60 mg/day. Paroxetine dose range: 20-40 mg/day. |
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Outcomes | Hamilton Rating Scale for Depression (HDRS-21), Clinical Anxiety Scale, BSRT, BIMT, CLAS, CTT, WPW, MMSE and Clinical Global Impression | |
Notes | Depression response: total score less than 10 on the HDRS. Anxiety response: total score less than 8 on the CAS. Funding: by industry |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |