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CompletedPhase 4Results posted

Antidepressant Medication Plus Donepezil for Treating Late-life Depression

Maintenance Therapies in Late-Life Depression: MTLD III

Lead sponsor

University of Pittsburgh

Assets

Donepezil / Duloxetine / Escitalopram / Venlafaxine

Listed sites

Recruiting sites

Enrollment

220

actual

Study population

Mixed / unspecified dementia

Key I/E criterion

•Age ≥65

Primary endpoints

•Global Cognitive Performance•Cognitive Instrumental Activities of Daily Living (IADL)•Recurrence of Major Depression

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

Secondary0312018

NCT IDNCT00177671

NihR01MH043832

Org study IDR01MH043832-03https://reporter.nih.gov/quickSearch/R01MH043832-03

Timeline

Milestones

Study start2003-12 (month precision)

Study first posted2005-09-15estimated

Primary completion2009-09actual (month precision)

Study completion2009-09actual (month precision)

Results first posted2011-06-08estimated

Last update posted2013-02-06estimated

Assets

Drug assets

Donepezil Duloxetine Escitalopram Venlafaxine

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Current episode of major depression

•HRS-D 17-item score of 15 or higher

•Must be able to speak English

•Willing to discontinue other psychotropics

•Availability of family member/caregiver

•Hearing capacity adequate to respond to raised conversational voice

•Must have no formal diagnosis of dementia

Exclusion criteria

•Meets DSM-IV criteria for bipolar disorder, schizophrenia, schizoaffective disorder, or a psychotic disorders

•Alcohol/drug abuse within 12 months of study entry

•History of treatment non-adherence in other clinic protocols

•History of non-response to citalopram in other clinic protocols

•History of non-tolerance to SSRI therapy

Endpoints (7)

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.

Coverage by outcome category

Global cognition

Function / daily living

Behavior / neuropsychiatric

Disease progression

Global cognition

2 endpoints

Primary/protocol endpoint

Global Cognitive Performance

Time frame:Measured at baseline and Years 1 and 2 in maintenance

descriptive

Primary/registry result

Global Cognitive Performance

Time frame:Measured at baseline and Years 1 and 2 in maintenance

descriptive

Posted result

Group	Value (mean), Z-score	Standard deviation
DonepezilBaseline (N=67;N=63)n=67 Participants	-0.47	0.88
Year 1 (N=45; N=57)n=67 Participants	-0.23	0.79
Year 2 N=42; N=49)n=67 Participants	-0.31	0.92
PlaceboBaseline (N=67;N=63)n=63 Participants	-0.47	0.76
Year 1 (N=45; N=57)n=63 Participants	-0.65	0.81
Year 2 N=42; N=49)n=63 Participants	-0.56	0.90

Function / daily living

2 endpoints

Primary/protocol endpoint

Cognitive Instrumental Activities of Daily Living (IADL)

Time frame:baseline, year 1 and year 2

threshold achievement, improvement

Primary/registry result

Cognitive Instrumental Activities of Daily Living (IADL)

Time frame:baseline, year 1 and year 2

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	Reported bounds
DonepezilBaseline (N=33; N=34)n=33 Participants	54.10	-
Year 1 (N=23; N=25)n=33 Participants	62.16	-
Year 2 (N=11; N=17)n=33 Participants	36.67	-
PlaceboBaseline (N=33; N=34)n=34 Participants	61.82	-
Year 1 (N=23; N=25)n=34 Participants	54.35	-
Year 2 (N=11; N=17)n=34 Participants	47.22	-

Behavior / neuropsychiatric

2 endpoints

Primary/protocol endpoint

Number of Participants With Recurrence of Major Depression

Time frame:2 years

event count, event

Primary/registry result

Number of Participants With Recurrence of Major Depression

Time frame:2 years

event count, event

Posted result

Group	Value (number), participants	Reported bounds
Donepeziln=67 Participants	19	-16 - 31
Placebon=63 Participants	11	-6 - 18

Hazard Ratio (HR)3.9795% CI1.00 - 4.41p.05Log Rank

Disease progression

1 endpoint

Post_hoc/registry result

Percentage of Participants With Mild Cognitive Impairment Converting to Dementia.

Time frame:2 year

time to event, event

Posted result

Group	Value (number), Percent of Participants	Reported bounds
Donepeziln=30 Participants	10	-
Placebon=27 Participants	33	-

Publications (5)

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 tableClinicalTrials.gov results section

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.