← Trials/Trial dossier/NCT00073658

CompletedPhase 2

Treating Behavioral Disturbances in Individuals With Dementia

Continuation Pharmacotherapy for Agitation of Dementia

Lead sponsor

University of Pittsburgh

Assets

Citalopram / Risperidone

Listed sites

Recruiting sites

Enrollment

137

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

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

SecondaryDSIR GT-GP

NCT IDNCT00073658

Org study IDR01MH059666-02https://reporter.nih.gov/quickSearch/R01MH059666-02

NihR01MH059666-02

Timeline

Milestones

Study start2000-01 (month precision)

Study first posted2003-12-03estimated

Primary completion2005-06actual (month precision)

Study completion2005-06actual (month precision)

Last update posted2014-03-10estimated

Assets

Drug assets

Citalopram Risperidone

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of Alzheimer's type dementia and/or meet criteria for probable or possible Alzheimer's disease

•Inpatient admittance to Western Psychiatric Institute and Clinic

•Written informed consent from participant's legally authorized representative with the participant's assent

•Psychosis or behavioral problems severe enough to be a danger to the participant's health, well-being, or safety

•Score of 3 to 6 (moderate to severe) on at least one of the Neurobehavioral Rating Scale (NBRS) agitation or psychosis items

•Ability to participate in study evaluation and ingest oral medication

Exclusion criteria

•Diagnosis of an unstable medical illness within the last 12 months

•Kidney or liver dysfunction

•Diagnosis of delirium, substance-induced persisting dementia, or vascular dementia

•Score of 12 or higher on the Cornell Scale for Depression in Dementia, and a score greater than 3 on the depression item of the NBRS

•Diagnosis of Parkinson's disease or any neurological illness which may affect cognitive function

•History of schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, or bipolar affective disorder

•Alcohol or substance abuse or dependence

•Receiving monoamine oxidase inhibitors within 15 days of study

•Display behaviors which could endanger the participant's life or the lives of others

•Received fluoxetine within 4 weeks of screening

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 (10)

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.