Completed

Continuation Pharmacotherapy for Agitation of Dementia

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is being recruted

Mental Disorders
+3

+ Brain Diseases
+ Central Nervous System Diseases
Over 50 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2000
See protocol details

Summary

Principal SponsorUniversity of Pittsburgh
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2000Actual date on which the first participant was enrolled.

Dementia-related behavioral disturbances have been associated with excess disability, increased caregiver burden, and premature institutionalization. Pharmacotherapy is often necessary to treat these disturbances. This study will use citalopram and risperidone to treat people with dementia-related behavior problems. Participants in this study will begin a psychotropic medication washout period for up to 3 days at study start. Participants will then be randomly assigned to receive either citalopram or risperidone for up to 12 weeks. Limited doses of the sedative lorazepam may be administered as needed throughout the study. During the first 2 weeks of the study, participants will be admitted to a hospital to have their dementia-related behavioral disturbances stabilized. Following hospital discharge, participants will move to a long-term care facility or a residential home and will continue medication treatment for up to 10 weeks. Side effects and improvements in behavioral status will be assessed every week until Week 6 and every 2 weeks thereafter. Experimental laboratory measures will be collected at study start, Week 1, Week 2, and every 2 weeks thereafter until Week 12. Upon study completion, patients may continue to receive citalopram or risperidone under the supervision of their current physicians. Three months after study completion, participants may be contacted for a follow-up report of their psychiatric and medical status.

Official TitleContinuation Pharmacotherapy for Agitation of Dementia 
NCT00073658
Principal SponsorUniversity of Pittsburgh
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
137 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 50 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Dementia
Nervous System Diseases
Neurocognitive Disorders
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



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
University of Pittsburgh Medical Center/Western Psychiatric Institute and ClinicPittsburgh, United StatesSee the location

CompletedOne Study Center
;