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EscBPSD

CompletedPhase 4

Escitalopram Treatment for BPSD in Alzheimer's Disease in Comparison to Risperidone

Post Marketing Study of Escitalopram Versus Risperidone for the Treatment of Behavioral and Psychological Symptoms Amongst Alzheimer's Disease Patients

Assets

Escitalopram / Risperidone

Listed sites

1

Recruiting sites

-

Enrollment

40

actual

Study population

Alzheimer’s disease

Key I/E criterion

•MMSE 5-26

Primary endpoint

•Neuropsychiatric Inventory (NPI)

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 IDABR-BPSD-001
Other grantCO01ABR01022008Lundbeck A/S
NCT IDNCT01119638

Timeline

Milestones

Study start2008-04 (month precision)
Primary completion2010-04actual (month precision)
Study completion2010-05actual (month precision)
Study first posted2010-05-07estimated
Last update posted2015-06-24estimated

Assets

Drug assets

EscitalopramRisperidone

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
Maximum age95 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Eligible participants will fulfill criteria for dementia of the Alzheimer's type (according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition). The score on the Mini-Mental State Examination (MMSE) has to be between 5 and 26.

Eligible patients will suffer from delusions, hallucinations, aggression, or agitation that developed after the onset of dementia and is severe enough to disrupt their functioning and, in the opinion of the study physicians, to justify treatment with antipsychotic drugs.

Signs and symptoms of psychosis, aggression, or agitation will have to occur nearly daily during the week prior to enrollment.

A frequency rating of "often" or "more frequently" and a severity rating of at least "moderate" are required for delusions, hallucinations, agitation, or "aberrant motor behavior" in the Neuropsychiatric Inventory (NPI)

Exclusion criteria

Patients will be excluded if they had received a diagnosis of a primary psychotic disorder (e.g., schizophrenia), delirium, other dementia. Patients will also be excluded if they were going to receive treatment with a cholinesterase inhibitor or antidepressant medication, had previously been treated with escitalopram for BPSD, or had contraindications to the two study drugs.

Endpoints (2)

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

Behavior / neuropsychiatric
1
Other (unclassified)
1

Behavior / neuropsychiatric

1 endpoint
Primary/protocol endpoint

Change in total score on the NPI.

Time frame:from first treatment to end of study at 6 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Time from initial treatment to the discontinuation of treatment for any reason.

Time frame:time to discontinuation for any reason

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.