title: Sertraline for the treatment of depression in Alzheimer disease.
abstract: OBJECTIVE
  Depression is common in Alzheimer disease (AD), and antidepressants are commonly used for its treatment, however, evidence for antidepressant efficacy in this population is lacking. The authors conducted a multicenter, randomized, placebo-controlled trial titled "Depression in Alzheimer's Disease-2" to assess the efficacy and tolerability of sertraline for depression in AD.
  
  
  METHODS
  One hundred thirty-one participants from five U.S. medical centers with mild-to-moderate AD (Mini-Mental State Examination scores 10-26) and depression of AD were randomized to double-blinded treatment with sertraline (N = 67) or placebo (N = 64), with a target dosage of 100 mg daily. Efficacy was assessed using logistic regressions and mixed effects models in an intention-to-treat analysis with imputation of missing data. Principal outcome measures were modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC), change in Cornell Scale for Depression in Dementia (CSDD) scores, and remission defined by both mADCS-CGIC score <or=2 and CSDD score <or=6.
  
  
  RESULTS
  mADCS-CGIC ratings (odd ratio [OR = 1.01], 95% confidence interval [CI]: 0.52-1.97, p = 0.98), CSDD scores (median difference at 12 weeks 1.2, 95% CI: 1.65-4.05, p = 0.41), and remission at 12 weeks of follow-up (OR = 2.06, 95% CI: 0.84-5.04, p = 0.11) did not differ between sertraline (N = 67) and placebo (N = 64). Sertraline-treated patients experienced more adverse events, most notably gastrointestinal and respiratory, than placebo-treated patients.
  
  
  CONCLUSIONS
  Sertraline did not demonstrate efficacy for the treatment depression symptoms in patients with AD. In addition, its use was associated with an increased incidence of adverse events. Thus, selective serotonin reuptake inhibitors may be of limited value for treating depression in patients with AD.
authors.affiliation: Division of Geriatric Psychiatry and Neuropsychiatry, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA. prosenb9@jhmi.edu
authors.forename: Paul B
authors.initials: PB
authors.lastname: Rosenberg
authors.forename: Lea T
authors.initials: LT
authors.lastname: Drye
authors.forename: Barbara K
authors.initials: BK
authors.lastname: Martin
authors.forename: Constantine
authors.initials: C
authors.lastname: Frangakis
authors.forename: Jacobo E
authors.initials: JE
authors.lastname: Mintzer
authors.forename: Daniel
authors.initials: D
authors.lastname: Weintraub
authors.forename: Anton P
authors.initials: AP
authors.lastname: Porsteinsson
authors.forename: Lon S
authors.initials: LS
authors.lastname: Schneider
authors.forename: Peter V
authors.initials: PV
authors.lastname: Rabins
authors.forename: Cynthia A
authors.initials: CA
authors.lastname: Munro
authors.forename: Curtis L
authors.initials: CL
authors.lastname: Meinert
authors.forename: Constantine G
authors.initials: CG
authors.lastname: Lyketsos
mesh_terms: D000368:Aged; D000544:Alzheimer Disease / Q000150:complications*; D003863:Depression / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D010352:Patient Dropouts / Q000706:statistics & numerical data; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D020280:Sertraline / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D016903:Drug Monitoring
chemical_list: D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline