The Depression in Alzheimer's Disease Study (DIADS)
Status:
Completed
Trial end date:
2007-11-01
Target enrollment:
Participant gender:
Summary
Major depression afflicts approximately 25 percent of patients with AD. Depression in AD
patients leads to mental suffering, behavioral disturbance (such as aggression), poor
cognition, poor self-care, caregiver depression, caregiver burden, and early entry into the
nursing home. Since major depression is treatable, this additional disability may be
avoidable. The use of antidepressants to treat major depression in AD is supported by two
studies, although a third does not show a benefit for antidepressants over placebo. Also, the
safety of antidepressant treatment in depressed AD patients is poorly studied. A conclusive
study showing that depression reduction in AD can be accomplished safely with antidepressant
medications, and that depression reduction is associated with improvements in activities of
daily living, non-mood behavioral disturbances, caregiver burden, and caregiver depression
would have major clinical and cost implications for the care of the AD patient. This study is
a 13-week, double blind, flexible dose, placebo controlled trial of sertraline in the
treatment of outpatients with AD and co-morbid major depression. The hypothesis is that
antidepressant treatment is superior to placebo in improving mood, in improving cognition, in
reducing physical dependency, in reducing caregiver depression, and in reducing caregiver
burden. It is also hypothesized that the degree of depression reduction is correlated with
these improvements. It is further hypothesized that the safety profile of sertraline when
compared to placebo is acceptable, especially with regard to risk of falls, sleep
disturbance, and delirium. One hundred community residing outpatients with probable AD who
also meet DSM-IV criteria for major depressive episode will be recruited into the study. They
will be randomized to sertraline or placebo and followed through weekly telephone contact by
an experienced clinical trials team. Outcomes will be assessed every 3 weeks, for a total of
four followup data points. Scales assessing the following domains will be used: depression,
cognition, behavioral disturbance, physical dependency, delirium, falls, sleep, other side
effects, caregiver depression, caregiver burden, caregiver functioning, and caregiver health.