Design of depression in Alzheimer's disease study-2

Barbara K. Martin, Constantine E. Frangakis, Paul B. Rosenberg, Jacobo E. Mintzer, Ira R. Katz, Anton P. Porsteinsson, Lon S. Schneider, Peter V. Rabins, Cynthia A. Munro, Curtis L. Meinert, George Niederehe, Constantine G. Lyketsos

Research output: Contribution to journalArticlepeer-review

33 Scopus citations


Objective: Research on the efficacy of antidepressant therapy for depressive symptoms in Alzheimer disease has been hampered by lack of systematic diagnosis, small sample sizes, and short-term follow up. To address these issues, the authors present the design of the Depression in Alzheimer's Disease Study-2 (DIADS-2), a randomized, placebo-controlled multicenter trial to evaluate the efficacy and safety of the selective serotonin reuptake inhibitor sertraline for the treatment of depression in people with Alzheimer disease. Methods: The authors present and discuss the following important aspects of the design: the inclusion of structured psychosocial therapy for the caregivers of all participants; the measurement not only of patient mood outcomes, but also of global and functional outcomes for patients and mood and burden outcomes for caregivers; the ongoing rating of multiple diagnostic criteria to allow nosologic study of depression in Alzheimer disease; the evaluation of both short-term efficacy and longer-term outcomes; the follow up of all patients regardless of whether they complete study treatment; and the unmasking of treatment assignment at the conclusion of each patient's treatment phase. Conclusions: The authors believe these design elements are important features to be included in trials of depression and other neuropsychiatric disturbances in Alzheimer disease.

Original languageEnglish (US)
Pages (from-to)920-930
Number of pages11
JournalAmerican Journal of Geriatric Psychiatry
Issue number11
StatePublished - Nov 2006


  • Alzheimer disease
  • Clinical trial
  • Controlled trial
  • Depression
  • Randomized
  • Selective serotonin reuptake inhibitors
  • Sertraline

ASJC Scopus subject areas

  • Geriatrics and Gerontology
  • Psychiatry and Mental health


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