Design of Depression in Alzheimer's Disease Study-2.
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.
Martin
Barbara K
BK
Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. bmartin@jhsph.edu
Frangakis
Constantine E
CE
Rosenberg
Paul B
PB
Mintzer
Jacobo E
JE
Katz
Ira R
IR
Porsteinsson
Anton P
AP
Schneider
Lon S
LS
Rabins
Peter V
PV
Munro
Cynthia A
CA
Meinert
Curtis L
CL
Niederehe
George
G
Lyketsos
Constantine G
CG
D000339:Affect; D000368:Aged; D000544:Alzheimer Disease / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use*; D017028:Caregivers / Q000193:education / Q000523:psychology; D003131:Combined Modality Therapy; D017281:Cost of Illness; D003376:Counseling; D003866:Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D010352:Patient Dropouts; D011340:Problem Solving; D011785:Quality Assurance, Health Care; D012107:Research Design; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D020280:Sertraline / Q000009:adverse effects / Q000627:therapeutic use*; D012944:Social Support; D016896:Treatment Outcome
D018687:Antidepressive Agents, Second-Generation; D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline