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Design of Depression in Alzheimer's Disease Study-2

From Johns Hopkins Bloomberg School of Public Health (BKM, CEF, CLM, CGL), Baltimore, MD; Johns Hopkins School of Medicine (PBR, PVR, CAM), Baltimore, MD; the Medical University of South Carolina (JEM), Charleston; the University of Pennsylvania School of Medicine (IRK), Philadelphia; the University of Rochester School of Medicine (APP), Rochester, NY; the University of Southern California Keck School of Medicine (LSS), Los Angeles; and the National Institute of Mental Health (GN); for the DIADS-2 Research Group.

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.

Key Words: Alzheimer disease • depression • randomized, controlled trial • clinical trial • selective serotonin reuptake inhibitors • sertraline

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