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NCT00009191 · ClinicalTrials.gov registry record · Phase 4
The Depression in Alzheimer's Disease Study (DIADS)
A Phase 4 study of Depression and Alzheimer Disease, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 4
- Development phase
- 1
- Study location
NCT00009191 is a Phase 4 study of Depression and Alzheimer Disease that has completed, run by Johns Hopkins University. The trial reports 1 study location across 1 state.
The verdict
NCT00009191, a Phase 4 study of Depression and Alzheimer Disease, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1
- Study location
Study 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 follo
Conditions Studied
Interventions
- DRUG Sertraline [Zoloft]
Study Locations (1)
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Start Date | 2005-11 |
| Est. Completion | 2007-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00009191
The ClinicalTrials.gov registry entry for NCT00009191 describes a study currently listed as completed, categorized as Phase 4. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 1 intervention - of which Sertraline [Zoloft] is the first listed.
NCT00009191 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00009191 about?
NCT00009191 is a clinical study titled "The Depression in Alzheimer's Disease Study (DIADS)". 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 depress...
What is the current status of trial NCT00009191?
This trial is currently completed. It is a Phase 4 study. The study started on 2005-11. Estimated completion is 2007-11.
What conditions does trial NCT00009191 study?
This clinical trial studies the following conditions: Depression, Alzheimer Disease.
What interventions are being tested in trial NCT00009191?
The interventions under investigation include: Sertraline [Zoloft] (DRUG).
Who is sponsoring clinical trial NCT00009191?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00009191 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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