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← Trials/Trial dossier/NCT00009191

CompletedPhase 4

The Depression in Alzheimer's Disease Study (DIADS)

Asset

Sertraline

Listed sites

1

Recruiting sites

-

Enrollment

-

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required

Primary endpoint

-

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

SecondaryIA0010
NCT IDNCT00009191
Org study IDR01MH056511https://reporter.nih.gov/quickSearch/R01MH056511
NihR01MH056511

Timeline

Milestones

Study first posted2001-01-24estimated
Study start2005-11 (month precision)
Primary completion2006-11actual (month precision)
Study completion2007-11actual (month precision)
Last update posted2018-08-20actual

Assets

Drug assets

Sertraline

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted

Eligibility criteria

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.

Endpoints (0)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

No endpoints recorded for this trial.

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.