title: Discontinuation of antidepressants in people with dementia and neuropsychiatric symptoms (DESEP study): double blind, randomised, parallel group, placebo controlled trial.
abstract: OBJECTIVE
  To determine the effect of discontinuing antidepressant treatment in people with dementia and neuropsychiatric symptoms.
  
  
  METHODS
  Double blind, randomised, parallel group, placebo controlled trial.
  
  
  METHODS
  Norwegian nursing homes; residents recruited by 16 study centres in Norway from August 2008 to June 2010.
  
  
  METHODS
  128 patients with Alzheimer's disease, dementia or vascular dementia, and neuropsychiatric symptoms (but no depressive disorder), who had been prescribed escitalopram, citalopram, sertraline, or paroxetine for three months or more. We excluded patients with severe somatic disease or terminal illness, or who were unable to take tablets or capsules as prescribed.
  
  
  METHODS
  Antidepressant treatment was discontinued over one week in 63 patients, and continued in 68 patients. We assessed patients at baseline, four, seven, 13, and 25 weeks.
  
  
  METHODS
  Primary outcomes were score differences between study groups in the Cornell scale of depression in dementia and the neuropsychiatric inventory (10 item version) after 25 weeks. Secondary outcomes were score differences in the clinical dementia rating scale, unified Parkinson's disease rating scale, quality of life-Alzheimer's disease scale, Lawton and Brody's physical self maintenance scale, and severe impairment battery.
  
  
  RESULTS
  Using a linear multilevel model analysis, we found that the discontinued group had significantly higher scores on the Cornell scale after 25 weeks than the continuation group (difference -2.89 (95% confidence interval -4.76 to -1.02); P=0.003). We saw a similar result in the mean total score for the neuropsychiatric inventory after 25 weeks, but this difference was non-significant (-5.96 (-12.35 to 0.44); P=0.068). We confirmed these results by non-response analysis (>30% worsening on the Cornell scale)--significantly more patients worsened in the discontinuation group than in the continuation group (32 (54%) v 17 (29%); P=0.006). We found no significant differences between the groups for secondary outcomes. Forty seven (37%) patients withdrew from the study early.
  
  
  CONCLUSIONS
  Discontinuation of antidepressant treatment in patients with dementia and neuropsychiatric symptoms leads to an increase in depressive symptoms, compared with those patients who continue with treatment.
  
  
  BACKGROUND
  ClinicalTrial.gov NCT00594269, EudraCT 2006-002790-43.
authors.affiliation: Centre for Old Age Psychiatric Research, Innlandet Hospital Trust, N-2312 Ottestad, Norway. sverre.bergh@sykehuset-innlandet.no
authors.forename: Sverre
authors.initials: S
authors.lastname: Bergh
authors.forename: Geir
authors.initials: G
authors.lastname: Selbæk
authors.forename: Knut
authors.initials: K
authors.lastname: Engedal
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000928:Antidepressive Agents / Q000627:therapeutic use*; D003704:Dementia / Q000150:complications / Q000175:diagnosis / Q000523:psychology; D003863:Depression / Q000150:complications / Q000188:drug therapy*; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D015577:Geriatric Assessment; D006801:Humans; D008297:Male; D058027:Neuropsychiatry / Q000379:methods; D009483:Neuropsychological Tests; D017063:Outcome Assessment, Health Care; D028761:Withholding Treatment
chemical_list: D000928:Antidepressive Agents