Abstract
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 language | English (US) |
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Pages (from-to) | 920-930 |
Number of pages | 11 |
Journal | American Journal of Geriatric Psychiatry |
Volume | 14 |
Issue number | 11 |
DOIs | |
State | Published - Nov 2006 |
Keywords
- Alzheimer disease
- Clinical trial
- Controlled trial
- Depression
- Randomized
- Selective serotonin reuptake inhibitors
- Sertraline
ASJC Scopus subject areas
- Geriatrics and Gerontology
- Psychiatry and Mental health