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DESEP

CompletedPhase 4

Dementia Antipsychotics And Antidepressants Discontinuation Study

Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - a 24 Weeks Double Blind RCT.

Assets

Citalopram / Escitalopram / Paroxetine / Risperidone / Sertraline

Listed sites

8

Recruiting sites

-

Enrollment

149

actual

Study population

Alzheimer’s disease, Vascular cognitive impairment / dementia

Key I/E criterion

•Multiple dementia etiologies

Primary endpoints

•Neuropsychiatric Inventory (NPI)•Changes in Cornell's Depression Scale•Changes in UPDRS subscale

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

Org study IDF06001
NCT IDNCT00594269

Timeline

Milestones

Study first posted2008-01-15estimated
Study start2008-08 (month precision)
Primary completion2010-12actual (month precision)
Study completion2010-12actual (month precision)
Last update posted2011-02-23estimated

Assets

Drug assets

CitalopramEscitalopramParoxetineRisperidoneSertraline

Study populations

Who this study enrolls

Alzheimer’s diseaseVascular cognitive impairment / dementia

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Vascular- or Alzheimer Dementia
•Nursing Homes resident for 3 months or more
•Given antipsychotics or antidepressants for 3 months or more
•Clinical Dementia rating 1, 2 or 3

Exclusion criteria

•Dementia of other origin
•Psychiatric disease
•Life expectancy less than 3 months
•Acute infection last 10 days
•Unstable Diabetes Mellitus
•Terminal disease

Endpoints (10)

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

Other (unclassified)
4
Global cognition
2
Behavior / neuropsychiatric
2
Caregiver / quality of life
1
Other clinical outcomes
1

Global cognition

2 endpoints
Secondary/protocol endpoint

Changes in Severe Impairment Battery

Time frame:24 weeks

descriptive

Secondary/protocol endpoint

Clinical Dementia Rating

Time frame:24 weeks

descriptive

Behavior / neuropsychiatric

2 endpoints
Primary/protocol endpoint

Changes in Neuropsychiatric Inventory

Time frame:24 weeks

Neuropsychiatric Inventory (NPI)

descriptive

Primary/protocol endpoint

Changes in Cornell's Depression Scale

Time frame:24 weeks

descriptive

Caregiver / quality of life

1 endpoint
Secondary/protocol endpoint

Quality of Life - Alzheimer disease

Time frame:24 weeks

descriptive

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Number of falls

Time frame:24 weeks

event count, event

Other (unclassified)

4 endpoints
Primary/protocol endpoint/low confidence

Changes in UPDRS subscale

Time frame:24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Changes in Lawton's PADL

Time frame:24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Oxazepam given p.n.

Time frame:24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Changes in Body Weight

Time frame:24 weeks

descriptive

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.