The Depression in Alzheimer's Disease Study (DIADS)
| Status: | Completed |
|---|---|
| Conditions: | Alzheimer Disease, Depression, Depression |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 8/22/2018 |
| Start Date: | November 2005 |
| End Date: | November 2007 |
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.
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.
Inclusion:
- Diagnosis of Probable Alzheimer's disease (AD) by NINCDS/ADRDA criteria (McKann et
al., 1984), with a MMSE score greater than 10
- Diagnosis of current major depressive episode (MD), by DSM-IV, based on the SCID-IV
examination
- Patients will be included even if they have a pre-AD history of unipolar depression
- Patients who currently are being treated with antidepressants but continue to meet
criteria for MD (i.e., have not responded to the medications) and who are willing to
discontinue the other medication and enter the study also will be included
- Currently residing in the community (own home,family member's home, or small group
home) and agreeing to 13 weeks of followup in the study
- Stable medical history and general health, in the opinion of the study psychiatrist
- A caregiver who knows the patient well (spends at least 10 hours per week with him or
her), and who is in reasonably good health, agrees to participate as well
- Participant and his/her legal representative provide informed consent
Exclusion:
- Use of sertraline is contraindicated, based on the Food and Drug Administration
package insert for sertraline
- Patient has a lifetime diagnosis of schizophrenia, bipolar disorder, or pre-AD anxiety
disorder, as determined by the SCID
- Patient has a current substance use disorder, as determined by the SCID
- Patient is acutely suicidal or requires inpatient psychiatric hospitalization, as
determined by the study psychiatrist
- No psychotropic medicine dose changes, including cholinesterase inhibitors, after
study entry
- May enter with any drug except another antidepressant.
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