- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00249158
A Study of the Effectiveness and Safety of Risperidone in the Treatment of Behavioral Disturbances in Patients With Dementia
November 18, 2010 updated by: Janssen-Cilag Pty Ltd
Risperidone in the Treatment of Behavioural and Psychological Signs and Symptoms in Dementia (BPSSD): a Multicentre, Double-blind, Placebo-controlled Parallel-group Trial
The purpose of the study is to compare the effectiveness of an oral formulation of risperidone (an antipsychotic medication) to that of placebo for treating behavioral and psychological signs and symptoms in dementia (BPSSD), specifically aggression, delusions, and hallucinations, in patients with dementia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Dementia is a term used for a collection of symptoms that can be caused by a number of diseases or injuries that affect the brain.
Individuals with dementia have a loss of function in cognition (thinking, perception, learning, verbal communication, memory, judgment), which may lead to behavioral and personality changes (for example, agitation, delusions, hallucinations).
Some causes of dementia are reversible; however, irreversible dementia is caused by certain conditions, such as Alzheimer's disease.
Dementia is common in elderly individuals, but it is not a normal part of aging.
This is a randomized, double-blind, parallel-group, placebo-controlled study comparing the effectiveness and safety of risperidone to placebo in patients with behavioral disturbances associated with dementia.
The study is composed of two periods: a 1-week run-in period in which patients are discontinued from other antipsychotic drugs and take placebo twice daily and a 12-week double-blind period.
At the end of the run-in period, patients are randomly assigned to oral solutions of either risperidone or placebo.
The starting dose of risperidone is 0.25 mg twice daily and increasing to 0.5 mg twice daily (1 mg/day).
If 1 mg/day shows an insufficient response, a maximum of 1 mg twice daily of risperidone is permitted.
The patient receives study drugs for the 12-week double-blind period.
The primary measure of effectiveness is the change from baseline to the end of double-blind treatment in the Cohen-Mansfield Agitation Inventory (CMAI), a questionnaire evaluating agitation.
Additional measures of efficacy include the change from baseline to end of double-blind treatment in the Behavior Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD), a rating scale used to evaluate behavior symptoms in patients with Alzheimer's disease; the Clinical Global Impressions (CGI), a rating system used to evaluate the overall and severity of clinical change in a patient with various diseases affecting the brain; the Functional Assessment Staging (FAST), a diagnosis tool for determining the stage of dementia; and the Mini-Mental State Examination (MMSE), a clinical measure used to evaluate cognition.
Safety evaluations include the incidence of adverse events; results of clinical laboratory tests (hematology and biochemistry); measurements of vital signs and body weight; physical examination findings; and the Extrapyramidal Symptoms Rating Scale (ESRS), a scale used to measure effects of antipsychotic medications on motor functions of the patient.
The study hypothesis is that risperidone is more effective than placebo, as measured by the total aggression score on the CMAI, in treating behavioral disturbances in demented patients.
Risperidone oral solution (1 mg/mL).
Starting doses of 0.25 mg twice daily and increasing to 0.5 mg twice daily (1 mg/day).
If 1 mg/day shows an insufficient response, a maximum of 1 mg twice daily of risperidone is permitted.
Total treatment duration is 12 weeks.
Study Type
Interventional
Enrollment (Actual)
344
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Dementia of the Alzheimer's type with behavioral disturbance, vascular dementia with behavioral disturbance, or mixed dementia, as classified by DSM-IV (the Diagnostic and Statistical Manual of Mental Diseases, 4th edition)
- a score >=4 on the FAST (Functional Assessment Staging, a diagnosis tool for determining the stage of dementia) and a score <=23 on the MMSE (Mini-Mental State Examination, a clinical measure used to evaluate cognition)
- a BEHAVE-AD (Behavior Pathology in Alzheimer's Disease Rating Scale) total score >=8, and a BEHAVE-AD global rating >=1
- patient must be living in an nursing home for >=1 month. Exclusion Criteria:
- Patients with other medical or neurological conditions other than dementia in which cognition is diminished (for example, severe anemia, severe liver, heart, lung, and kidney malfunctions, Parkinson's disease)
- diagnosis of depression within the 6 months before study entry, schizophrenia, bipolar affective disorder, or schizoaffective disorder
- history of or moderate to severe tardive dyskinesia, (a condition of uncontrollable movements of the tongue, lips, face, trunk, hands and feet that is seen in patients receiving long-term medication with certain types of antipsychotic drugs)
- abnormal clinical laboratory test findings.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Change from baseline to the end of double-blind treatment in total aggression score of the CMAI (Cohen-Mansfield Agitation Inventory).
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Secondary Outcome Measures
Outcome Measure |
---|
Change from baseline to end of double-blind treatment in global and total BEHAVE-AD score, BEHAVE-AD cluster scores and in CMAI cluster scores, CGI, and in FAST MMSE; safety evaluations conducted throughout the study.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 1998
Study Completion (Actual)
February 1, 2001
Study Registration Dates
First Submitted
November 4, 2005
First Submitted That Met QC Criteria
November 4, 2005
First Posted (Estimate)
November 7, 2005
Study Record Updates
Last Update Posted (Estimate)
November 19, 2010
Last Update Submitted That Met QC Criteria
November 18, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Tauopathies
- Intracranial Arterial Diseases
- Intracranial Arteriosclerosis
- Leukoencephalopathies
- Dementia
- Alzheimer Disease
- Dementia, Vascular
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- Risperidone
Other Study ID Numbers
- CR006010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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