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Randomised, double blind, placebo controlled trial.
Participants and assessors blinded.
Follow up period:
Eight weeks with assessments at baseline and endpoint; the three primary outcome variables were also assessed every 2 weeks.
Multicentre trial in the USA; timeframe not specified.
752 people, age ⩾60 years (75% ⩾65) with major depressive disorder (MDD; DSM-IV criteria), and scoring ⩾18 on the Hamilton Depression Scale (HAMD) with a score ⩾2 on item 1 (depressed mood), and a minimum of 4 weeks of symptoms. Exclusions: bipolar disorder, schizophrenia, or other psychosis; Mini-Mental State Exam (MMSE) score <24; DSM-IV diagnosis of dementia, organic mental disorder, or mental retardation; or a significant unstable medical condition.
Sertraline 50–100 mg, flexible dose; placebo for 8 weeks. …
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