Sertraline improves depression scores in the elderly in the short term, regardless of medical comorbidity status.

What are the effects of sertraline in elderly people with depression, taking comorbid medical illnesses into consideration?METHODS:DESIGN: Randomised, double blind, placebo controlled trial.Allocation: Concealed.Blinding: 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.SETTING: Multicentre trial in the USA; timeframe not specified.PATIENTS: 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.Intervention: Sertraline 50-100 mg, flexible dose; placebo for 8 weeks.Outcomes: Depression, measured with the primary outcomes: HAMD Clinical Global Impression-Severity scale (CGI-S) and the Clinical Global Impression-Improvement (CGI-I) scale. Response was defined as an endpoint CGI-I score of 1 (very much) or 2 (much) and a reduction >/=50% in HAMD. Safety and adverse events also assessed.Patient follow up: 97% of participants received at least one dose of study medication and were included in the ITT analysis. Safety: data presented for 80% of participants.MAIN RESULTS:The intention to treat analysis included 728 participants. 442 participants had medical comorbiditities (vascular disease, diabetes, or arthritis) and were likely to be older, retired, widowed, female, and to have lower ratings of quality of life and functioning than those with no comorbidities (n = 127). Efficacy: at 8 weeks, sertraline significantly improved depression scores compared with placebo for the overall sample (see httP://www.ebmentalhealth.com/supplemental for table). There were no significant differences in changes of depression score from baseline between people with and without comorbidities for both the placebo and sertraline groups. Adverse events: data presented for 458 participants. More people taking scrtraline discontinued the trial compared with placebo; however statistical comparisons between groups are not presented (sertraline: 25/172, 15% v placebo 11/232, 5%). Discontinuation rates were similar for people with and without comorbidities for both the sertraline and placebo groups.CONCLUSIONS:Sertraline improved depression scores in elderly people both with and without comorbidities.NOTES:Results from the 159 people without vascular disease, diabetes, or arthritis but with a current prescription or hospitalisation in the preceding year are not reported in this study. To be included in the ITT analysis, participants only had to take one dose of medication. More detailed information on the adherence rate, or number of doses taken by participants are not presented. Discontinuation rates are presented for 458/569 (80%) participants.