Status:
COMPLETED
Treating Behavioral Disturbances in Individuals With Dementia
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Dementia
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
This study will compare the safety and effectiveness two medications, citalopram (Celexa®) and risperidone (Risperdal®).
Detailed Description
Dementia-related behavioral disturbances have been associated with excess disability, increased caregiver burden, and premature institutionalization. Pharmacotherapy is often necessary to treat these ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT00073658
Start Date
January 1 2000
End Date
June 1 2005
Last Update
March 10 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Pittsburgh Medical Center/Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213