Treating Behavioral Disturbances in Individuals With Dementia

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare the safety and effectiveness two medications, citalopram (Celexa®) and risperidone (Risperdal®).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Citalopram; Risperidone

Criteria

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